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
248
Posts
1,265
Discussion Threads
248
Posts
1,265
White Label Vs Private Label Requirements

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Discussion Threads
120
Posts
627
Discussion Threads
120
Posts
627
GB9706.1:2020 - in-country testing

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Discussion Threads
2,409
Posts
14,602
Discussion Threads
2,409
Posts
14,602
MDD certificate expiration

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussion Threads
95
Posts
414
Discussion Threads
95
Posts
414
Licensing Requirements for Third Party Logistics Providers

UK Medical Device Regulations

UK Medical Device Regulations, especially with respect to BREXIT issues.
Discussion Threads
64
Posts
284
Discussion Threads
64
Posts
284
MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD)

US Medical Device Regulations

United States Medical Device Regulations
Discussion Threads
2,227
Posts
13,107
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Discussion Threads
2,227
Posts
13,107
Leaving or Dropping MDSAP

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Discussion Threads
858
Posts
5,048
Discussion Threads
858
Posts
5,048
What is the Brazil - ABIMED Registration Process
Discussions
M
MAUDE Report
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4
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2,121
margadia
R
Transport of components off site for final assembly.
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2
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741
regi_601
A
Add MDSAP to Internal Audit Schedule
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0
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1,178
AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
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0
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1,129
jdlin47
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