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
238
Posts
1,228
Discussion Threads
238
Posts
1,228
How to sell Veterinary Devices to Canada

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
118
Posts
614
Discussion Threads
118
Posts
614
Outsourcing registration to a local company

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
2,200
Posts
13,448
Discussion Threads
2,200
Posts
13,448
Definition of disease as per medical device defintion
  • Tidge

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussion Threads
91
Posts
406
Discussion Threads
91
Posts
406
Change of PVC stabilizer

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
Discussion Threads
50
Posts
214
Discussion Threads
50
Posts
214
Technical documentation for UKCA

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,181
Posts
12,871
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,181
Posts
12,871
FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
825
Posts
4,927
Discussion Threads
825
Posts
4,927
KGMP (Korean GMP requirements) vs. ISO 13485
Discussions
M
MAUDE Report
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4
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694
margadia
R
Transport of components off site for final assembly.
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2
Views
289
regi_601
A
Add MDSAP to Internal Audit Schedule
Replies
0
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721
AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
Replies
0
Views
647
jdlin47
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