Medical Device Related Regulations

Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.

Canada Medical Device Regulations

This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
Discussion Threads
199
Posts
1,062
Discussion Threads
199
Posts
1,062
GMDN code update - Canada - Do you know if there is guidance?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
104
Posts
544
Discussion Threads
104
Posts
544
Advertising and promotion of device under investigation

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
1,734
Posts
11,040
Discussion Threads
1,734
Posts
11,040
Looking for a EU MDR Gap Analysis template

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussion Threads
82
Posts
380
Discussion Threads
82
Posts
380
Medical Device Vigilance decision tree for Japan for class 2 devices.

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
Discussion Threads
6
Posts
30
Discussion Threads
6
Posts
30
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,009
Posts
11,847
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,009
Posts
11,847
510(k) review timeline

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
771
Posts
4,696
Discussion Threads
771
Posts
4,696
Indian Medical Device Rule - January 29th, 2017
Discussions
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