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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.
Discussion Threads
207
Posts
1,089
Discussion Threads
207
Posts
1,089
Health Canada Submission

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
1,848
Posts
11,617
Discussion Threads
1,848
Posts
11,617
ELISA reader - IVDR classification

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
18
Posts
74
Discussion Threads
18
Posts
74
Selling a product in Both UK and EU after Brexit

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,049
Posts
12,099
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,049
Posts
12,099
Unrealistic Packaging Validation Sample Size
  • Bev D

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
788
Posts
4,781
Discussion Threads
788
Posts
4,781
Taiwan Medical Device Importation
Discussions
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Add MDSAP to Internal Audit Schedule
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0
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62
AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
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0
Views
98
jdlin47
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