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
217
Posts
1,113
Discussion Threads
217
Posts
1,113
Business Number versus Company ID?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
106
Posts
558
Discussion Threads
106
Posts
558
IVD registration renewal in China

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
1,922
Posts
11,955
Discussion Threads
1,922
Posts
11,955
Competent Authority non-EU Manufacturer

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussion Threads
82
Posts
383
Discussion Threads
82
Posts
383
Looking for a Japan MAH recommendation that is not too expensive

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
Discussion Threads
23
Posts
125
Discussion Threads
23
Posts
125
MDD VS MDR 2002-218

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,069
Posts
12,212
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,069
Posts
12,212
Final Report re: Market withdrawal of radiation-emitting product

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
793
Posts
4,802
Discussion Threads
793
Posts
4,802
MDD Distributor Registration Requirements
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Add MDSAP to Internal Audit Schedule
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AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
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0
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228
jdlin47
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