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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
248
Posts
1,265
Discussion Threads
248
Posts
1,265
White Label Vs Private Label Requirements
Mar 15, 2023
noslo6
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
Mar 10, 2023
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
2,409
Posts
14,602
Discussion Threads
2,409
Posts
14,602
MDD certificate expiration
Today at 6:39 AM
aravindh
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
Feb 24, 2023
regularengineer
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)
Yesterday at 6:54 PM
dgrainger
US Medical Device Regulations
United States Medical Device Regulations
Discussion Threads
2,227
Posts
13,107
Sub-forums:
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
Other US Medical Device Regulations
Discussion Threads
2,227
Posts
13,107
Leaving or Dropping MDSAP
Today at 12:19 AM
barbierimarkh
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
Today at 3:01 AM
Belinda Lin
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MAUDE Report
margadia
Mar 4, 2022
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4
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2,121
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
Views
741
Jan 21, 2022
regi_601
A
Add MDSAP to Internal Audit Schedule
AADIVISH
Apr 5, 2021
Replies
0
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1,178
Apr 5, 2021
AADIVISH
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
jdlin47
Mar 22, 2021
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0
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1,129
Mar 22, 2021
jdlin47
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