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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.
Threads
263
Posts
1.3K
Threads
263
Posts
1.3K
A
Is There a Revision History or Change Log for Canadian Regulations?
Mar 7, 2024
AQAGRL
China Medical Device Regulations
SFDA regulations and other applicable regulations related to medical devices in China.
Threads
135
Posts
679
Threads
135
Posts
679
D
Returning Overseas Implantable Complaint Product to China
Feb 29, 2024
Daniel Zhang
EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Threads
2.6K
Posts
15.6K
Threads
2.6K
Posts
15.6K
C
Service Number - Labelling
Yesterday at 3:49 AM
CraigRegulatory
Japan Medical Device Regulations
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
101
Posts
435
Threads
101
Posts
435
A
Time limit for removing IVC Filter
Yesterday at 9:25 AM
Apple
UK Medical Device Regulations
UK Medical Device Regulations, especially with respect to BREXIT issues.
Threads
79
Posts
335
Threads
79
Posts
335
M
Auditor comment on UK Labelling
Yesterday at 10:26 AM
Mazza
US Medical Device Regulations
United States Medical Device Regulations
Threads
2.3K
Posts
13.6K
Sub-forums:
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
Other US Medical Device Regulations
Threads
2.3K
Posts
13.6K
J
Class I Exempt FDA Question
Friday at 1:15 PM
jbm12
Other Medical Device Regulations World-Wide
Regulatory systems around the world different from the ones in the above sub-forums.
Threads
882
Posts
5.1K
Threads
882
Posts
5.1K
R
Sending documents to COFEPRIS, Mexico
Wednesday at 9:03 AM
Regsblue
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Ear, nose, and throat E.N.T devices
nizark
Mar 27, 2023
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Mar 27, 2023
nizark
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MAUDE Report
margadia
Mar 4, 2022
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Mar 8, 2022
margadia
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Transport of components off site for final assembly.
regi_601
Jan 21, 2022
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2
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1K
Jan 21, 2022
regi_601
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A
Add MDSAP to Internal Audit Schedule
AADIVISH
Apr 5, 2021
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Apr 5, 2021
AADIVISH
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Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
jdlin47
Mar 22, 2021
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Mar 22, 2021
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