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.

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Canada Medical Device Regulations

This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
Threads
170
Messages (Posts)
908
Threads
170
Messages (Posts)
908
Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Threads
84
Messages (Posts)
465
Threads
84
Messages (Posts)
465
Docs for Medical Device registration in China - List of certificates

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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1,278
Messages (Posts)
8,150
Threads
1,278
Messages (Posts)
8,150
Risk Management Report as per MDR Requirements
  • yodon

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
77
Messages (Posts)
365
Threads
77
Messages (Posts)
365
Japan Minor Change Notification Application Form - Found it?

US Medical Device Regulations

United States Medical Device Regulations
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1,805
Messages (Posts)
10,588
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
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1,805
Messages (Posts)
10,588
Design Control for Class I Medical Devices

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Threads
630
Messages (Posts)
4,024
Threads
630
Messages (Posts)
4,024
Challenges Incorporating Mobile Devices into Medical Devices
Discussions
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Medical Device Research Use Only (RUO) label
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2
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77
SANE
M
IVD Registration - Use of Prospective Study Data
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0
Views
38
Mallappa
T
Series A ready company - Term for medical devices companies?
Replies
0
Views
67
Timothea
Ajit Basrur
Any recommended courses to FDA and CBP Import Process?
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0
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52
Ajit Basrur
S
Is Lot Number required in addition to UDI serial number?
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0
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47
SGquality
Sidney Vianna
Medical Device News International exposé of the harm caused by poorly tested medical devices.
2
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12
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426
Sidney Vianna
C
Attestation of QA certificate from foreign (EU) Notified Body
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6
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176
catechol
J
How important is using the "correct" GMDN?
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4
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112
moounir
K
Moist Heat Sterilization worldwide Requirements and Regulations
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1
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63
planB
J
INMETRO process of Hypodermic Needle in Brazil
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1
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64
Marcelo Antunes
G
Regulatory requirements for secondary packages in terms of label content
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2
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146
shimonv
M
Translation requirements for marketing materials
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1
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128
shimonv
G
Single DFU for multiple medical devices in one box
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0
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71
guymlech
A
Who pays for correction and removal actions?
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2
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139
supadrai
M
Translate Procedures into Spanish
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5
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145
AndyN
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