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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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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
238
Posts
1,228
Discussion Threads
238
Posts
1,228
How to sell Veterinary Devices to Canada
Jun 10, 2022
ANASTASIYA
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
Jun 10, 2022
TimZhao
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
Friday at 8:26 AM
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
May 11, 2022
Judy Abbott
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
Thursday at 9:04 AM
GiuliaGe
US Medical Device Regulations
United States Medical Device Regulations
Discussion Threads
2,181
Posts
12,871
Sub-forums:
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
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
Jun 17, 2022
Tidge
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
Jun 13, 2022
Clueless One
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MAUDE Report
margadia
Mar 4, 2022
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4
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694
Mar 8, 2022
margadia
R
Transport of components off site for final assembly.
regi_601
Jan 21, 2022
Replies
2
Views
289
Jan 21, 2022
regi_601
A
Add MDSAP to Internal Audit Schedule
AADIVISH
Apr 5, 2021
Replies
0
Views
721
Apr 5, 2021
AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
jdlin47
Mar 22, 2021
Replies
0
Views
647
Mar 22, 2021
jdlin47
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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