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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
181
Messages (Posts)
974
Threads
181
Messages (Posts)
974
Does Class 1 Medical Device need to be certified to MDSAP?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
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95
Messages (Posts)
525
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95
Messages (Posts)
525
China NMPA medical device submission timelines and clearance rates

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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1,462
Messages (Posts)
9,467
Threads
1,462
Messages (Posts)
9,467
Please explain MDR Rule 11 to me

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
80
Messages (Posts)
374
Threads
80
Messages (Posts)
374
Japan AE (Adverse Event) Reporting Requirements

US Medical Device Regulations

United States Medical Device Regulations
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1,898
Messages (Posts)
11,093
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Threads
1,898
Messages (Posts)
11,093
Inside the Bubble 2019

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
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665
Messages (Posts)
4,235
Threads
665
Messages (Posts)
4,235
Medical Device Registration Process in Brazil - Anvisa (Part 3)
Discussions
P
Change on Medical Device Classifications - Dental Crowns
Replies
2
Views
81
Mikilk
N
Medical Device claims that I make in my promotional/advertising materials
Replies
9
Views
132
Watchcat
N
Technical file requirements class 1 device MDR
Replies
6
Views
126
noanalyst
S
Device name change and label color change EU requirement?
Replies
6
Views
107
sugizo521
A
What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site?
Replies
3
Views
166
anbknaga
G
QMS requirements for legal manufacturer when outsourcing manufacturing process
2 3
Replies
22
Views
484
Watchcat
N
Medical Device Misclassified by Health Canada
Replies
2
Views
125
noanalyst
M
Microbiological Testing Lab - Layout & Standards
Replies
0
Views
70
mpfizer
JoshuaFroud
How important is using the "correct" GMDN?
Replies
5
Views
493
med_cert
D
Preventative Maintenance for Gages, handtools etc
Replies
1
Views
88
John Broomfield
S
Estimated cost for MDR certification
Replies
7
Views
286
yodon
N
How to look up all Class 1 medical devices on sale in Canada
Replies
3
Views
163
noanalyst
V
CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing
Replies
3
Views
187
Watchcat
L
Staying up to date on Regulations
Replies
8
Views
231
Ron Rompen
XRAY_3121
Informational MDSAP Audit Findings - Document change orders
2
Replies
12
Views
716
Ronen E
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