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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.
Threads
183
Posts
985
Threads
183
Posts
985
What does SOR and DORS stand for in the Medical Devices Regulations?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Threads
97
Posts
529
Threads
97
Posts
529
Looking for China Good manufacturing practice

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Threads
1,527
Posts
9,916
Threads
1,527
Posts
9,916
Annex XVI Device Transition Timeline under the MDR

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
80
Posts
377
Threads
80
Posts
377
Medical device package insert in EU and USA

US Medical Device Regulations

United States Medical Device Regulations
Threads
1,932
Posts
11,385
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Threads
1,932
Posts
11,385
FDA Class 1 Medical Device UDI requirements

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Threads
725
Posts
4,508
Threads
725
Posts
4,508
South Korea, MFDS - Medical Device Change Management
Discussions
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