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
226
Posts
1,172
Discussion Threads
226
Posts
1,172
Direct vs. Post-License Investigational Test Authorization (ITA)

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
109
Posts
578
Discussion Threads
109
Posts
578
Circled-Z symbol on a syringe — what is it for, what does it mean?

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
2,018
Posts
12,439
Discussion Threads
2,018
Posts
12,439
Scope of ISO 13485 Certificate for Multiple Devices

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussion Threads
83
Posts
384
Discussion Threads
83
Posts
384
How to determine "generic/me too" device?

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
Discussion Threads
33
Posts
155
Discussion Threads
33
Posts
155
Establishment and Product Registration Procedure - UK & EU

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,115
Posts
12,437
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,115
Posts
12,437
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
799
Posts
4,840
Discussion Threads
799
Posts
4,840
Swiss Authorized representative & non-medical device regulations
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Add MDSAP to Internal Audit Schedule
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AADIVISH
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Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
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364
jdlin47
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