| Austria |
EU |
1 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Austrian Federal Office for Safety in Health Care (BASG) |
| Austria |
EU |
1 |
2 |
Link to the authority website |
https://www.basg.gv.at/en/ |
| Austria |
EU |
1 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.basg.gv.at/en/healthcare-professionals/clinical-trials/clinical-trials-with-medical-devices |
| Austria |
EU |
1 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
5/25/2022 |
| Austria |
EU |
1 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Austria |
EU |
1 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Austria |
EU |
1 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Austria |
EU |
1 |
8 |
Link to the website of the performance monitoring system |
No |
| Austria |
EU |
1 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Austria |
EU |
1 |
10 |
Language of submission |
Local language & English |
| Belgium |
EU |
2 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Federal Agency for Medicines and Health Products – Belgium (FAMHP) |
| Belgium |
EU |
2 |
2 |
Link to the authority website |
https://www.famhp.be/en |
| Belgium |
EU |
2 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.afmps.be/sites/default/files/Guideline%20Submission%20of%20Clinical%20Investigation%20according%20to%20MDR_version%209.0_1.pdf |
| Belgium |
EU |
2 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/11/2024 |
| Belgium |
EU |
2 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Belgium |
EU |
2 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Belgium |
EU |
2 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Belgium |
EU |
2 |
8 |
Link to the website of the performance monitoring system |
No |
| Belgium |
EU |
2 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Belgium |
EU |
2 |
10 |
Language of submission |
Local language, English, Dutch and German |
| Bulgaria |
EU |
3 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Bulgarian Drug Agency, Ministry of Health (BDA) |
| Bulgaria |
EU |
3 |
2 |
Link to the authority website |
https://www.bda.bg/en/ |
| Bulgaria |
EU |
3 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.bda.bg/en/information-for-companies/114-medical-devices-category |
| Bulgaria |
EU |
3 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Bulgaria |
EU |
3 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Bulgaria |
EU |
3 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Bulgaria |
EU |
3 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Bulgaria |
EU |
3 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Bulgaria |
EU |
3 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Bulgaria |
EU |
3 |
10 |
Language of submission |
Local language & English |
| Croatia |
EU |
4 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) |
| Croatia |
EU |
4 |
2 |
Link to the authority website |
https://www.halmed.hr/en/ |
| Croatia |
EU |
4 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.halmed.hr/O-HALMED-u/Sredisnje-eticko-povjerenstvo-SEP/Naputci-podnositeljima-zahtjeva/ |
| Croatia |
EU |
4 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Croatia |
EU |
4 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Croatia |
EU |
4 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://sep.halmed.hr/ |
| Croatia |
EU |
4 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Croatia |
EU |
4 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Croatia |
EU |
4 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Croatia |
EU |
4 |
10 |
Language of submission |
Local language only |
| Cyprus |
EU |
5 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Cyprus Medical Devices Competent Authority (CYMDA) |
| Cyprus |
EU |
5 |
2 |
Link to the authority website |
https://www.moh.gov.cy/Moh/mphs/mphs.nsf/home2/home2?openform |
| Cyprus |
EU |
5 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.moh.gov.cy/moh/mphs/mphs.nsf/page23_en/page23_en?OpenDocument |
| Cyprus |
EU |
5 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/15/2020 |
| Cyprus |
EU |
5 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Cyprus |
EU |
5 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Cyprus |
EU |
5 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Cyprus |
EU |
5 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Cyprus |
EU |
5 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Cyprus |
EU |
5 |
10 |
Language of submission |
Local language & English |
| Czechia |
EU |
6 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
State Institute for Drug Control – Czech Republic (SÚKL) |
| Czechia |
EU |
6 |
2 |
Link to the authority website |
https://www.sukl.eu/ |
| Czechia |
EU |
6 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.sukl.eu/medical-devices/podani-zadosti-o-povoleni-provedeni-klinicke-zkousky |
| Czechia |
EU |
6 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/7/2015 |
| Czechia |
EU |
6 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Czechia |
EU |
6 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://prehledy.sukl.cz/prehled_kh.html |
| Czechia |
EU |
6 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Czechia |
EU |
6 |
8 |
Link to the website of the performance monitoring system |
No |
| Czechia |
EU |
6 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Czechia |
EU |
6 |
10 |
Language of submission |
Local language & English |
| Denmark |
EU |
7 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Danish Medicines Agency (DMA / Laegemiddelstyrelsen) |
| Denmark |
EU |
7 |
2 |
Link to the authority website |
https://laegemiddelstyrelsen.dk/en/devices/clinical-investigations |
| Denmark |
EU |
7 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://laegemiddelstyrelsen.dk/en/devices/new-regulations/ |
| Denmark |
EU |
7 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
6/22/2023 |
| Denmark |
EU |
7 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Denmark |
EU |
7 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Denmark |
EU |
7 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Denmark |
EU |
7 |
8 |
Link to the website of the performance monitoring system |
No |
| Denmark |
EU |
7 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Denmark |
EU |
7 |
10 |
Language of submission |
Local language & English |
| Estonia |
EU |
8 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Estonian Health Board (Health Board) |
| Estonia |
EU |
8 |
2 |
Link to the authority website |
https://www.terviseamet.ee/en/medical-devices/regulatory-controls |
| Estonia |
EU |
8 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.terviseamet.ee/en/clinical-investigations-and-performance-studies |
| Estonia |
EU |
8 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Estonia |
EU |
8 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Estonia |
EU |
8 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Estonia |
EU |
8 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Estonia |
EU |
8 |
8 |
Link to the website of the performance monitoring system |
No |
| Estonia |
EU |
8 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Estonia |
EU |
8 |
10 |
Language of submission |
Local language & English |
| Finland |
EU |
9 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Finnish Medicines Agency (Fimea) |
| Finland |
EU |
9 |
2 |
Link to the authority website |
www.fimea.fi |
| Finland |
EU |
9 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://fimea.fi/en/medical-devices/investigations-with-devices |
| Finland |
EU |
9 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Finland |
EU |
9 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Finland |
EU |
9 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Finland |
EU |
9 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Finland |
EU |
9 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Finland |
EU |
9 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Finland |
EU |
9 |
10 |
Language of submission |
Local language, English & Swedish |
| France |
EU |
10 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
| France |
EU |
10 |
2 |
Link to the authority website |
Accueil - ANSM (sante.fr) |
| France |
EU |
10 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
Dispositifs médicaux - Demander une autorisation pour une inves - ANSM (sante.fr) |
| France |
EU |
10 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
2/13/2023 |
| France |
EU |
10 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| France |
EU |
10 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| France |
EU |
10 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| France |
EU |
10 |
8 |
Link to the website of the performance monitoring system |
N/A |
| France |
EU |
10 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| France |
EU |
10 |
10 |
Language of submission |
Local language & English |
| Germany |
EU |
11 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Federal Institute for Drugs and Medical Devices – Germany (BfArM) |
| Germany |
EU |
11 |
2 |
Link to the authority website |
https://www.bfarm.de/EN/Home/_node.html |
| Germany |
EU |
11 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.bfarm.de/EN/Medical-devices/Tasks/Clinical-investigations-and-performance-studies/Clinical-investigations/Request-for-authorisation-kp/_node.html |
| Germany |
EU |
11 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
8/17/2022 |
| Germany |
EU |
11 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Germany |
EU |
11 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://drks.de/search/de |
| Germany |
EU |
11 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Germany |
EU |
11 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Germany |
EU |
11 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Germany |
EU |
11 |
10 |
Language of submission |
Local language & English |
| Greece |
EU |
12 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Organization for Medicines – Greece (EOF) |
| Greece |
EU |
12 |
2 |
Link to the authority website |
https://www.eof.gr/web/guest;jsessionid=481cac2bbf55496b479bb61f0bc1 |
| Greece |
EU |
12 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.eof.gr/web/guest/clinical-md |
| Greece |
EU |
12 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Greece |
EU |
12 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Greece |
EU |
12 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Greece |
EU |
12 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Greece |
EU |
12 |
8 |
Link to the website of the performance monitoring system |
No |
| Greece |
EU |
12 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Greece |
EU |
12 |
10 |
Language of submission |
Local language & English |
| Hungary |
EU |
13 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Institute of Pharmacy and Nutrition – Hungary (OGYÉI) |
| Hungary |
EU |
13 |
2 |
Link to the authority website |
https://ogyei.gov.hu/main_page |
| Hungary |
EU |
13 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://ogyei.gov.hu/medical_devices/ |
| Hungary |
EU |
13 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
11/20/2023 |
| Hungary |
EU |
13 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Hungary |
EU |
13 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Hungary |
EU |
13 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Hungary |
EU |
13 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Hungary |
EU |
13 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Hungary |
EU |
13 |
10 |
Language of submission |
Local language & English |
| Ireland |
EU |
14 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Health Products Regulatory Authority – Ireland (HPRA) |
| Ireland |
EU |
14 |
2 |
Link to the authority website |
www.hpra.ie |
| Ireland |
EU |
14 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.hpra.ie/homepage/medical-devices/regulatory-information/medical-devices-regulation/clinical-investigations |
| Ireland |
EU |
14 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
11/18/2022 |
| Ireland |
EU |
14 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Ireland |
EU |
14 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Ireland |
EU |
14 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Ireland |
EU |
14 |
8 |
Link to the website of the performance monitoring system |
No |
| Ireland |
EU |
14 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Ireland |
EU |
14 |
10 |
Language of submission |
Local language & English |
| Italy |
EU |
15 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
General Directorate of Medical Devices and Pharmaceutical Service – Italy (GDMDPS) |
| Italy |
EU |
15 |
2 |
Link to the authority website |
https://www.salute.gov.it/portale/ministro/p4_5_2_4_1.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1153 |
| Italy |
EU |
15 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.salute.gov.it/portale/moduliServizi/catalogoModuliServizi.jsp?lingua=italiano&label=servizionline&menu=ufficio&gruppoUfficioDir=DGDMF-UFFXIV&gruppoUfficio=ALL |
| Italy |
EU |
15 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
8/7/2024 |
| Italy |
EU |
15 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Italy |
EU |
15 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Italy |
EU |
15 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Italy |
EU |
15 |
8 |
Link to the website of the performance monitoring system |
No |
| Italy |
EU |
15 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Italy |
EU |
15 |
10 |
Language of submission |
Local language & English |
| Latvia |
EU |
16 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
State Agency of Medicines of Latvia (SAMLV) |
| Latvia |
EU |
16 |
2 |
Link to the authority website |
https://www.zva.gov.lv/en |
| Latvia |
EU |
16 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.zva.gov.lv/en/industry/medical-device-manufacturers-authorized-representatives/clinical-investigations-and-performance-studies |
| Latvia |
EU |
16 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
9/18/2023 |
| Latvia |
EU |
16 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Latvia |
EU |
16 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Latvia |
EU |
16 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Latvia |
EU |
16 |
8 |
Link to the website of the performance monitoring system |
No |
| Latvia |
EU |
16 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Latvia |
EU |
16 |
10 |
Language of submission |
Local language & English |
| Lithuania |
EU |
17 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
State Health Care Accreditation Agency – Lithuania (VASPVT) |
| Lithuania |
EU |
17 |
2 |
Link to the authority website |
https://vaspvt.lrv.lt/en/ |
| Lithuania |
EU |
17 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://vaspvt.lrv.lt/lt/medicinos-priemones-pagal-es-direktyvas/registravimas/ |
| Lithuania |
EU |
17 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
11/9/2023 |
| Lithuania |
EU |
17 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Lithuania |
EU |
17 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Lithuania |
EU |
17 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Lithuania |
EU |
17 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Lithuania |
EU |
17 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Lithuania |
EU |
17 |
10 |
Language of submission |
Local language only |
| Luxembourg |
EU |
18 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Ministry of Health – Luxembourg (Gesondheetsministère) |
| Luxembourg |
EU |
18 |
2 |
Link to the authority website |
https://msan.gouvernement.lu/en.html |
| Luxembourg |
EU |
18 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://sante.public.lu/fr/espace-professionnel/domaines/recherche-biomedicale/investigation-clinique-dispositifs-medicaux.html |
| Luxembourg |
EU |
18 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
10/20/2023 |
| Luxembourg |
EU |
18 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Luxembourg |
EU |
18 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Luxembourg |
EU |
18 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Luxembourg |
EU |
18 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Luxembourg |
EU |
18 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Luxembourg |
EU |
18 |
10 |
Language of submission |
Local language, English & German |
| Malta |
EU |
19 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Malta Medicines Authority (MMA) |
| Malta |
EU |
19 |
2 |
Link to the authority website |
https://medicinesauthority.gov.mt |
| Malta |
EU |
19 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Malta |
EU |
19 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Malta |
EU |
19 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Malta |
EU |
19 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Malta |
EU |
19 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Malta |
EU |
19 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Malta |
EU |
19 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Malta |
EU |
19 |
10 |
Language of submission |
Local language & English |
| Netherlands |
EU |
20 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Central Committee on Research Involving Human Subjects – Netherlands (CCMO) |
| Netherlands |
EU |
20 |
2 |
Link to the authority website |
https://english.ccmo.nl/ |
| Netherlands |
EU |
20 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://english.ccmo.nl/investigators/clinical-investigations-with-medical-devices |
| Netherlands |
EU |
20 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
3/1/2021 |
| Netherlands |
EU |
20 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Netherlands |
EU |
20 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm
https://onderzoekmetmensen.nl/nl |
| Netherlands |
EU |
20 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Netherlands |
EU |
20 |
8 |
Link to the website of the performance monitoring system |
No |
| Netherlands |
EU |
20 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Netherlands |
EU |
20 |
10 |
Language of submission |
Local language & English |
| Poland |
EU |
21 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Poland (URPL) |
| Poland |
EU |
21 |
2 |
Link to the authority website |
https://www.urpl.gov.pl/ |
| Poland |
EU |
21 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.urpl.gov.pl/pl/wyroby-medyczne/badania-kliniczne-wyrob%C3%B3w-medycznych/dokumenty-za%C5%82%C4%85czane-do-wniosk%C3%B3w |
| Poland |
EU |
21 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/1/2015 |
| Poland |
EU |
21 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Poland |
EU |
21 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Poland |
EU |
21 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Poland |
EU |
21 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Poland |
EU |
21 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Poland |
EU |
21 |
10 |
Language of submission |
Local language & English (some documents) |
| Portugal |
EU |
22 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Authority of Medicines and Health Products – Portugal (INFARMED) |
| Portugal |
EU |
22 |
2 |
Link to the authority website |
https://www.infarmed.pt/ |
| Portugal |
EU |
22 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos/investigacao-clinica-avaliacao-funcional/dm_meio_clinico_humano_adequado |
| Portugal |
EU |
22 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/1/2016 |
| Portugal |
EU |
22 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Portugal |
EU |
22 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Portugal |
EU |
22 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| Portugal |
EU |
22 |
8 |
Link to the website of the performance monitoring system |
https://www.infarmed.pt/web/infarmed/institucional/documentacao_e_informacao/documentos-institucionais#tab3 |
| Portugal |
EU |
22 |
9 |
Key performance indicators included in the performance monitoring system |
Yes |
| Portugal |
EU |
22 |
10 |
Language of submission |
Local language & English |
| Romania |
EU |
23 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Agency for Medicines and Medical Devices – Romania (NAMMDR) |
| Romania |
EU |
23 |
2 |
Link to the authority website |
https://www.anm.ro/en/dispozitive-medicale/ |
| Romania |
EU |
23 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.anm.ro/en/dispozitive-medicale/investigatie-clinica/ |
| Romania |
EU |
23 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Romania |
EU |
23 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Romania |
EU |
23 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Romania |
EU |
23 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Romania |
EU |
23 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Romania |
EU |
23 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Romania |
EU |
23 |
10 |
Language of submission |
N/A |
| Slovakia |
EU |
24 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
State Institute for Drug Control – Slovak Republic (_ÚKL) |
| Slovakia |
EU |
24 |
2 |
Link to the authority website |
https://www.sukl.sk/ |
| Slovakia |
EU |
24 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.sukl.sk/sk/zdravotnicke-pomocky-informacie/informacie-tykajuce-sa-trhoveho-dohladu-vigilancie-a-klinickeho-skusania?page_id=5699 |
| Slovakia |
EU |
24 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Slovakia |
EU |
24 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Slovakia |
EU |
24 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Slovakia |
EU |
24 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Slovakia |
EU |
24 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Slovakia |
EU |
24 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Slovakia |
EU |
24 |
10 |
Language of submission |
Local language only |
| Slovenia |
EU |
25 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Agency for Medicinal Products and Medical Devices of Slovenia (JAZMP) |
| Slovenia |
EU |
25 |
2 |
Link to the authority website |
https://www.jazmp.si/en/ |
| Slovenia |
EU |
25 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.jazmp.si/en/medical-devices/clinical-investigations/ |
| Slovenia |
EU |
25 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Slovenia |
EU |
25 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Slovenia |
EU |
25 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Slovenia |
EU |
25 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Slovenia |
EU |
25 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Slovenia |
EU |
25 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Slovenia |
EU |
25 |
10 |
Language of submission |
N/A |
| Spain |
EU |
26 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Spanish Agency of Medicines and Medical Devices (AEMPS) |
| Spain |
EU |
26 |
2 |
Link to the authority website |
https://www.aemps.gob.es/ |
| Spain |
EU |
26 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
Investigaciones clínicas con productos sanitarios | Agencia Española de Medicamentos y Productos Sanitarios (aemps.gob.es) |
| Spain |
EU |
26 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/30/2023 |
| Spain |
EU |
26 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Spain |
EU |
26 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Spain |
EU |
26 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Spain |
EU |
26 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Spain |
EU |
26 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Spain |
EU |
26 |
10 |
Language of submission |
Local language & English (some documents) |
| Sweden |
EU |
27 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Swedish Medical Products Agency (MPA) |
| Sweden |
EU |
27 |
2 |
Link to the authority website |
https://www.lakemedelsverket.se/en |
| Sweden |
EU |
27 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.lakemedelsverket.se/en/permission-approval-and-control/clinical-trials/medical-devices/clinical-investigation-of-medical-device |
| Sweden |
EU |
27 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
5/12/2022 |
| Sweden |
EU |
27 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Sweden |
EU |
27 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Sweden |
EU |
27 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Sweden |
EU |
27 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Sweden |
EU |
27 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Sweden |
EU |
27 |
10 |
Language of submission |
Local language & English |
| Iceland |
EEA |
28 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Icelandic Medicines Agency (IMA / Lyfjastofnun) |
| Iceland |
EEA |
28 |
2 |
Link to the authority website |
https://www.ima.is/ |
| Iceland |
EEA |
28 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.lyfjastofnun.is/laekningataeki/kliniskar-profanir-a-laekningataekjum/ |
| Iceland |
EEA |
28 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/20/2023 |
| Iceland |
EEA |
28 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Iceland |
EEA |
28 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Iceland |
EEA |
28 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Iceland |
EEA |
28 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Iceland |
EEA |
28 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Iceland |
EEA |
28 |
10 |
Language of submission |
Local language & English |
| Liechtenstein |
EEA |
29 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Office of Public Health – Principality of Liechtenstein (Amt für Gesundheit) |
| Liechtenstein |
EEA |
29 |
2 |
Link to the authority website |
https://www.llv.li/en/national-administration/office-of-public-health |
| Liechtenstein |
EEA |
29 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.llv.li/en/company/industry-professional-associations/health-professions-and-healing/medical-devices-in-vitro-diagnostics/clinical-exams |
| Liechtenstein |
EEA |
29 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/1/2023 |
| Liechtenstein |
EEA |
29 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Liechtenstein |
EEA |
29 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Liechtenstein |
EEA |
29 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Liechtenstein |
EEA |
29 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Liechtenstein |
EEA |
29 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Liechtenstein |
EEA |
29 |
10 |
Language of submission |
Local language & English |
| Norway |
EEA |
30 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Norwegian Medical Products Agency (NoMA) |
| Norway |
EEA |
30 |
2 |
Link to the authority website |
https://www.dmp.no/en |
| Norway |
EEA |
30 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.dmp.no/en/medical-devices/clinical-investigation-of-medical-devices |
| Norway |
EEA |
30 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
10/5/2023 |
| Norway |
EEA |
30 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Norway |
EEA |
30 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Norway |
EEA |
30 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Norway |
EEA |
30 |
8 |
Link to the website of the performance monitoring system |
No |
| Norway |
EEA |
30 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Norway |
EEA |
30 |
10 |
Language of submission |
Local language & English |
| Albania |
EMEA |
31 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Agency for Medicines and Medical Devices – Albania (AKBPM) |
| Albania |
EMEA |
31 |
2 |
Link to the authority website |
https://akbpm.gov.al/ |
| Albania |
EMEA |
31 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
ther's no section dedicated to pre market clinical investigation of MDs |
| Albania |
EMEA |
31 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Albania |
EMEA |
31 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Albania |
EMEA |
31 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
there is no database of pre-market clinical trials there is a database of all medical devices that is not published on the website by the Competent Authority |
| Albania |
EMEA |
31 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Albania |
EMEA |
31 |
8 |
Link to the website of the performance monitoring system |
No |
| Albania |
EMEA |
31 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Albania |
EMEA |
31 |
10 |
Language of submission |
Local language only |
| Georgia |
EMEA |
32 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Ministry of Health – Georgia (MoH Georgia) |
| Georgia |
EMEA |
32 |
2 |
Link to the authority website |
https://www.moh.gov.ge/law.php?uid=202308172104117935768264&lang=1&uid=202308172104117935768264 |
| Georgia |
EMEA |
32 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.moh.gov.ge/docs/20231206115504-10.pdf |
| Georgia |
EMEA |
32 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Georgia |
EMEA |
32 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Georgia |
EMEA |
32 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Georgia |
EMEA |
32 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Georgia |
EMEA |
32 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Georgia |
EMEA |
32 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Georgia |
EMEA |
32 |
10 |
Language of submission |
Local language & English (some documents) |
| Israel |
EMEA |
33 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Ministry of Health (MOH) |
| Israel |
EMEA |
33 |
2 |
Link to the authority website |
https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/MLD/Pages/default.aspx |
| Israel |
EMEA |
33 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.gov.il/he/departments/general/clinical-trials-medical-devices |
| Israel |
EMEA |
33 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
3/2/2023 |
| Israel |
EMEA |
33 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Israel |
EMEA |
33 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://my.health.gov.il/CliniTrials/Pages/Home.aspx |
| Israel |
EMEA |
33 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Israel |
EMEA |
33 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Israel |
EMEA |
33 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Israel |
EMEA |
33 |
10 |
Language of submission |
Local language & English (some documents) |
| Kazakhstan |
EMEA |
34 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Ministry of Healthcare of the Republic of Kazakhstan |
| Kazakhstan |
EMEA |
34 |
2 |
Link to the authority website |
https://www.gov.kz/memleket/entities/dsm?lang=en |
| Kazakhstan |
EMEA |
34 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.ndda.kz/category/inspekciya_mi |
| Kazakhstan |
EMEA |
34 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
6/14/2021 |
| Kazakhstan |
EMEA |
34 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Kazakhstan |
EMEA |
34 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
http://register.ndda.kz/category/search_prep |
| Kazakhstan |
EMEA |
34 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Kazakhstan |
EMEA |
34 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Kazakhstan |
EMEA |
34 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Kazakhstan |
EMEA |
34 |
10 |
Language of submission |
Local language & Russian |
| Russia |
EMEA |
35 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Federal Service for Surveillance in Healthcare – Russian Federation (Roszdravnadzor) |
| Russia |
EMEA |
35 |
2 |
Link to the authority website |
1) https://roszdravnadzor.gov.ru/
2) https://minzdrav.gov.ru/ |
| Russia |
EMEA |
35 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.ndda.kz/pages/5200 |
| Russia |
EMEA |
35 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Russia |
EMEA |
35 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Russia |
EMEA |
35 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
We have link only to approved clinical studies in Russia:
https://roszdravnadzor.gov.ru/services/clinic |
| Russia |
EMEA |
35 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Russia |
EMEA |
35 |
8 |
Link to the website of the performance monitoring system |
No |
| Russia |
EMEA |
35 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Russia |
EMEA |
35 |
10 |
Language of submission |
Local language only |
| Saudi Arabia |
EMEA |
36 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Saudi Food and Drug Authority (SFDA) |
| Saudi Arabia |
EMEA |
36 |
2 |
Link to the authority website |
https://www.sfda.gov.sa/en |
| Saudi Arabia |
EMEA |
36 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://sfda.gov.sa/en/regulations/66129 |
| Saudi Arabia |
EMEA |
36 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/19/2023 |
| Saudi Arabia |
EMEA |
36 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Saudi Arabia |
EMEA |
36 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Saudi Arabia |
EMEA |
36 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Saudi Arabia |
EMEA |
36 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Saudi Arabia |
EMEA |
36 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Saudi Arabia |
EMEA |
36 |
10 |
Language of submission |
Local language & English |
| South Africa |
EMEA |
37 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
South African Health Products Regulatory Authority (SAHPRA) |
| South Africa |
EMEA |
37 |
2 |
Link to the authority website |
https://www.sahpra.org.za/ |
| South Africa |
EMEA |
37 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.sahpra.org.za/clinical-trials/ |
| South Africa |
EMEA |
37 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| South Africa |
EMEA |
37 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| South Africa |
EMEA |
37 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| South Africa |
EMEA |
37 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| South Africa |
EMEA |
37 |
8 |
Link to the website of the performance monitoring system |
N/A |
| South Africa |
EMEA |
37 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| South Africa |
EMEA |
37 |
10 |
Language of submission |
Local language & English |
| Switzerland |
EMEA |
38 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Swiss Agency for Therapeutic Products (Swissmedic) |
| Switzerland |
EMEA |
38 |
2 |
Link to the authority website |
https://www.swissmedic.ch/swissmedic/en/home.html |
| Switzerland |
EMEA |
38 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/klinische-pruefungen.html www.swissmedic.ch/ clinical-investigations-en |
| Switzerland |
EMEA |
38 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/1/2023 |
| Switzerland |
EMEA |
38 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Switzerland |
EMEA |
38 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Switzerland |
EMEA |
38 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Switzerland |
EMEA |
38 |
8 |
Link to the website of the performance monitoring system |
No |
| Switzerland |
EMEA |
38 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Switzerland |
EMEA |
38 |
10 |
Language of submission |
Local language & English (some documents) |
| Tunisia |
EMEA |
39 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Directorate of Pharmacy and Medicines – Tunisia (DPM) |
| Tunisia |
EMEA |
39 |
2 |
Link to the authority website |
http://www.dpm.tn/ |
| Tunisia |
EMEA |
39 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
No |
| Tunisia |
EMEA |
39 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Tunisia |
EMEA |
39 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Tunisia |
EMEA |
39 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Tunisia |
EMEA |
39 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Tunisia |
EMEA |
39 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Tunisia |
EMEA |
39 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Tunisia |
EMEA |
39 |
10 |
Language of submission |
N/A |
| Turkey |
EMEA |
40 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Turkish Medicines and Medical Devices Agency (T_TCK) |
| Turkey |
EMEA |
40 |
2 |
Link to the authority website |
https://www.titck.gov.tr/ |
| Turkey |
EMEA |
40 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/55 |
| Turkey |
EMEA |
40 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
9/9/2024 |
| Turkey |
EMEA |
40 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Turkey |
EMEA |
40 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://ebs.titck.gov.tr/Public/KapNormalArama |
| Turkey |
EMEA |
40 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| Turkey |
EMEA |
40 |
8 |
Link to the website of the performance monitoring system |
NA |
| Turkey |
EMEA |
40 |
9 |
Key performance indicators included in the performance monitoring system |
Rate of compliance with the assessment deadlines specified in the Regulation which is fully compliance with EU MDR |
| Turkey |
EMEA |
40 |
10 |
Language of submission |
Local language & English |
| UK |
EMEA |
41 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Medicines and Healthcare products Regulatory Agency – United Kingdom (MHRA) |
| UK |
EMEA |
41 |
2 |
Link to the authority website |
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency |
| UK |
EMEA |
41 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#legislation-that-applies-in-great-britain |
| UK |
EMEA |
41 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
7/20/2023 |
| UK |
EMEA |
41 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| UK |
EMEA |
41 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| UK |
EMEA |
41 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| UK |
EMEA |
41 |
8 |
Link to the website of the performance monitoring system |
N/A |
| UK |
EMEA |
41 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| UK |
EMEA |
41 |
10 |
Language of submission |
Local language only |
| Canada |
NAFTA |
42 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Health Canada (HC) |
| Canada |
NAFTA |
42 |
2 |
Link to the authority website |
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices |
| Canada |
NAFTA |
42 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html |
| Canada |
NAFTA |
42 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
10/1/2018 |
| Canada |
NAFTA |
42 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Canada |
NAFTA |
42 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Canada |
NAFTA |
42 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| Canada |
NAFTA |
42 |
8 |
Link to the website of the performance monitoring system |
Only made available to trade associations |
| Canada |
NAFTA |
42 |
9 |
Key performance indicators included in the performance monitoring system |
Limited target regarding review cycles |
| Canada |
NAFTA |
42 |
10 |
Language of submission |
Local language only |
| USA |
NAFTA |
43 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Food and Drug Administration – United States (with local IRB) (FDA) |
| USA |
NAFTA |
43 |
2 |
Link to the authority website |
www.fda.gov |
| USA |
NAFTA |
43 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application |
| USA |
NAFTA |
43 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
10/3/2022 |
| USA |
NAFTA |
43 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| USA |
NAFTA |
43 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| USA |
NAFTA |
43 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| USA |
NAFTA |
43 |
8 |
Link to the website of the performance monitoring system |
https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports |
| USA |
NAFTA |
43 |
9 |
Key performance indicators included in the performance monitoring system |
Yes |
| USA |
NAFTA |
43 |
10 |
Language of submission |
Local language only |
| Argentina |
LATAM |
44 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Administration of Drugs, Foods and Medical Devices – Argentina (ANMAT) |
| Argentina |
LATAM |
44 |
2 |
Link to the authority website |
https://www.argentina.gob.ar/anmat |
| Argentina |
LATAM |
44 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.argentina.gob.ar/salud/registroinvestigaciones |
| Argentina |
LATAM |
44 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Argentina |
LATAM |
44 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Argentina |
LATAM |
44 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://sisa.msal.gov.ar/sisa/#sisa
(Includes not only medical device) |
| Argentina |
LATAM |
44 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Argentina |
LATAM |
44 |
8 |
Link to the website of the performance monitoring system |
No |
| Argentina |
LATAM |
44 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Argentina |
LATAM |
44 |
10 |
Language of submission |
Local language & English |
| Brazil |
LATAM |
45 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Brazilian Health Regulatory Agency (ANVISA) |
| Brazil |
LATAM |
45 |
2 |
Link to the authority website |
https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices |
| Brazil |
LATAM |
45 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/pesquisa-clinica/ensaios-clinicos-autorizados-e-indeferidos |
| Brazil |
LATAM |
45 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
6/16/2023 |
| Brazil |
LATAM |
45 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Brazil |
LATAM |
45 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/pesquisa-clinica/ensaios-clinicos-autorizados-e-indeferidos/ensaios-clinicos-envolvendo-dispositivos-medicos-autorizados-indeferidos-pela-anvisa-dicd.pdf/view (for class III a |
| Brazil |
LATAM |
45 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| Brazil |
LATAM |
45 |
8 |
Link to the website of the performance monitoring system |
https://conselho.saude.gov.br/plataforma-brasil-conep?view=default (enter in Brasil platform website section) |
| Brazil |
LATAM |
45 |
9 |
Key performance indicators included in the performance monitoring system |
· Total users registered.
· Total users registered in 2023.
· Total projects submitted.
· Total projects submitted in 2023.
· Total institutions registered. |
| Brazil |
LATAM |
45 |
10 |
Language of submission |
Local language & English |
| Chile |
LATAM |
46 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Institute of Public Health – Chile (ISP) |
| Chile |
LATAM |
46 |
2 |
Link to the authority website |
https://www.ispch.gob.cl/ |
| Chile |
LATAM |
46 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://giconaweb.ispch.gob.cl/ |
| Chile |
LATAM |
46 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Chile |
LATAM |
46 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Chile |
LATAM |
46 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Chile |
LATAM |
46 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Chile |
LATAM |
46 |
8 |
Link to the website of the performance monitoring system |
No |
| Chile |
LATAM |
46 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Chile |
LATAM |
46 |
10 |
Language of submission |
Local language & English |
| Colombia |
LATAM |
47 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Institute for Food and Drug Surveillance – Colombia (INVIMA) |
| Colombia |
LATAM |
47 |
2 |
Link to the authority website |
https://www.invima.gov.co/ |
| Colombia |
LATAM |
47 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/dispositivos-medicos-y-equipos-biomedicos |
| Colombia |
LATAM |
47 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
11/1/2023 |
| Colombia |
LATAM |
47 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
No |
| Colombia |
LATAM |
47 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
No |
| Colombia |
LATAM |
47 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Colombia |
LATAM |
47 |
8 |
Link to the website of the performance monitoring system |
No |
| Colombia |
LATAM |
47 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Colombia |
LATAM |
47 |
10 |
Language of submission |
Local language only |
| Paraguay |
LATAM |
48 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Directorate of Health Surveillance – Paraguay (DINAVISA) |
| Paraguay |
LATAM |
48 |
2 |
Link to the authority website |
https://www.mspbs.gov.py/dnvs |
| Paraguay |
LATAM |
48 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://dinavisa.gov.py/direccion-de-investigacion/ |
| Paraguay |
LATAM |
48 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Paraguay |
LATAM |
48 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Paraguay |
LATAM |
48 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://dinavisa.gov.py/wp-content/uploads/2023/09/Ensayos-Clinicos-Autorizados.pdf |
| Paraguay |
LATAM |
48 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Paraguay |
LATAM |
48 |
8 |
Link to the website of the performance monitoring system |
No |
| Paraguay |
LATAM |
48 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Paraguay |
LATAM |
48 |
10 |
Language of submission |
Local language, English & other languages (if translated) |
| Australia |
APAC |
49 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Therapeutic Goods Administration – Australia (TGA) |
| Australia |
APAC |
49 |
2 |
Link to the authority website |
https://www.tga.gov.au/ |
| Australia |
APAC |
49 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.tga.gov.au/clinical-trials |
| Australia |
APAC |
49 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
5/23/2022 |
| Australia |
APAC |
49 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Australia |
APAC |
49 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://www.anzctr.org.au/ |
| Australia |
APAC |
49 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
Yes |
| Australia |
APAC |
49 |
8 |
Link to the website of the performance monitoring system |
https://www.tga.gov.au/news/news/proactive-monitoring-highest-risk-medical-device-clinical-trials |
| Australia |
APAC |
49 |
9 |
Key performance indicators included in the performance monitoring system |
risk-based Good Clinical Practice (GCP) Inspection Program |
| Australia |
APAC |
49 |
10 |
Language of submission |
Local language only |
| China |
APAC |
50 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
National Medical Products Administration – China (NMPA) |
| China |
APAC |
50 |
2 |
Link to the authority website |
http://english.nmpa.gov.cn/index.html |
| China |
APAC |
50 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202100001 |
| China |
APAC |
50 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| China |
APAC |
50 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| China |
APAC |
50 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| China |
APAC |
50 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| China |
APAC |
50 |
8 |
Link to the website of the performance monitoring system |
N/A |
| China |
APAC |
50 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| China |
APAC |
50 |
10 |
Language of submission |
Local language only |
| Japan |
APAC |
51 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Pharmaceuticals and Medical Devices Agency – Japan (PMDA) |
| Japan |
APAC |
51 |
2 |
Link to the authority website |
https://www.pmda.go.jp/english/index.html |
| Japan |
APAC |
51 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
No |
| Japan |
APAC |
51 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Japan |
APAC |
51 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Japan |
APAC |
51 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://jrct.niph.go.jp/search?language=en |
| Japan |
APAC |
51 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
No |
| Japan |
APAC |
51 |
8 |
Link to the website of the performance monitoring system |
No |
| Japan |
APAC |
51 |
9 |
Key performance indicators included in the performance monitoring system |
No |
| Japan |
APAC |
51 |
10 |
Language of submission |
Local language only |
| India |
APAC |
52 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Central Drugs Standard Control Organization – India (CDSCO) |
| India |
APAC |
52 |
2 |
Link to the authority website |
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/ |
| India |
APAC |
52 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/ |
| India |
APAC |
52 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
1/1/2020 |
| India |
APAC |
52 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| India |
APAC |
52 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| India |
APAC |
52 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| India |
APAC |
52 |
8 |
Link to the website of the performance monitoring system |
N/A |
| India |
APAC |
52 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| India |
APAC |
52 |
10 |
Language of submission |
Local language & English |
| New_Zealand |
APAC |
53 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
New Zealand Medicines and Medical Devices Safety Authority (Medsafe) |
| New_Zealand |
APAC |
53 |
2 |
Link to the authority website |
https://medsafe.govt.nz/regulatory/devicesnew/13ConductingClinicalTrials.asp |
| New_Zealand |
APAC |
53 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://medsafe.govt.nz/regulatory/devicesnew/13ConductingClinicalTrials.asp |
| New_Zealand |
APAC |
53 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
10/5/2011 |
| New_Zealand |
APAC |
53 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| New_Zealand |
APAC |
53 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
Australian New Zeasland Clinical Trials Registry (ANZCTR.org.au) ANZCTR" |
| New_Zealand |
APAC |
53 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| New_Zealand |
APAC |
53 |
8 |
Link to the website of the performance monitoring system |
N/A |
| New_Zealand |
APAC |
53 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| New_Zealand |
APAC |
53 |
10 |
Language of submission |
Local language only |
| Republic_of_Korea |
APAC |
54 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Ministry of Food and Drug Safety – South Korea (MFDS) |
| Republic_of_Korea |
APAC |
54 |
2 |
Link to the authority website |
https://www.mfds.go.kr/eng/index.do |
| Republic_of_Korea |
APAC |
54 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
Clinical Trials (medsafe.govt.nz) |
| Republic_of_Korea |
APAC |
54 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
N/A |
| Republic_of_Korea |
APAC |
54 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Republic_of_Korea |
APAC |
54 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://cris.nih.go.kr/cris/index/index.do |
| Republic_of_Korea |
APAC |
54 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Republic_of_Korea |
APAC |
54 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Republic_of_Korea |
APAC |
54 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Republic_of_Korea |
APAC |
54 |
10 |
Language of submission |
Local language only |
| Taiwan |
APAC |
55 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Taiwan Food and Drug Administration (TFDA) |
| Taiwan |
APAC |
55 |
2 |
Link to the authority website |
https://www.fda.gov.tw/eng/ |
| Taiwan |
APAC |
55 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.fda.gov.tw/eng/siteList.aspx?sid=10337 |
| Taiwan |
APAC |
55 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
9/30/2022 |
| Taiwan |
APAC |
55 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
Yes |
| Taiwan |
APAC |
55 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
https://mdctp.fda.gov.tw/#/ |
| Taiwan |
APAC |
55 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Taiwan |
APAC |
55 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Taiwan |
APAC |
55 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Taiwan |
APAC |
55 |
10 |
Language of submission |
Local language & English |
| Singapore |
APAC |
56 |
1 |
Authority in charge of managing the pre-market clinical investigations for medical devices |
Health Sciences Authority – Singapore (HSA) |
| Singapore |
APAC |
56 |
2 |
Link to the authority website |
https://www.hsa.gov.sg/ |
| Singapore |
APAC |
56 |
3 |
Link to the section of the website dedicated to pre-market clinical investigations of MDs |
https://www.hsa.gov.sg/medical-devices/clinical-trials |
| Singapore |
APAC |
56 |
4 |
Date of last update of the section of the website dedicated to pre-market clinical investigations of MDs |
12/18/2023 |
| Singapore |
APAC |
56 |
5 |
Existence of a public database of pre-market clinical investigations of MDs |
N/A |
| Singapore |
APAC |
56 |
6 |
Link to the website of the database of pre-market clinical investigations of MDs |
N/A |
| Singapore |
APAC |
56 |
7 |
Existence of a performance monitoring system of the pre-market clinical investigations of MDs |
N/A |
| Singapore |
APAC |
56 |
8 |
Link to the website of the performance monitoring system |
N/A |
| Singapore |
APAC |
56 |
9 |
Key performance indicators included in the performance monitoring system |
N/A |
| Singapore |
APAC |
56 |
10 |
Language of submission |
Local language & English |