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
187
Posts
1,021
Discussion Threads
187
Posts
1,021
Is There a Revision History or Change Log for Canadian Regulations?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
100
Posts
537
Discussion Threads
100
Posts
537
China Medical Device Labeling requirements - Language

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
1,671
Posts
10,687
Discussion Threads
1,671
Posts
10,687
EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device;

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.

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
1,987
Posts
11,736
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
1,987
Posts
11,736
Should 510(k) Predicates be Actively Listed Devices?

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
753
Posts
4,622
Discussion Threads
753
Posts
4,622
Clue to UK's new regulatory requirements - approval of all devices placed on the market?
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