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
172
Messages (Posts)
915
Threads
172
Messages (Posts)
915
Selling products in Canada, distributor? Private Label?

China Medical Device Regulations

SFDA regulations and other applicable regulations related to medical devices in China.
Threads
85
Messages (Posts)
466
Threads
85
Messages (Posts)
466
China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices

EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Threads
1,299
Messages (Posts)
8,253
Threads
1,299
Messages (Posts)
8,253
BREXIT - What/How are You and Your Business Preparing for It?

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
78
Messages (Posts)
366
Threads
78
Messages (Posts)
366
Medical device package insert in EU and USA

US Medical Device Regulations

United States Medical Device Regulations
Threads
1,821
Messages (Posts)
10,682
Sub-forums:
  1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
  2. Other US Medical Device Regulations
Threads
1,821
Messages (Posts)
10,682
Change to the FDA cleared device (ours) - Submission or Letter to file?

Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.
Threads
635
Messages (Posts)
4,064
Threads
635
Messages (Posts)
4,064
Saudi Arabia - Insistence on a signed NB audit report (When one does not exist)
Discussions
Z
UDI assignment Criteria Software IVDR
Replies
0
Views
38
Zjiel
T
Change to Country of Origin on Medical Device Labeling
Replies
0
Views
67
tsteele
J
Referencing Medical Device in FDA records - Package contains several other components
Replies
1
Views
73
Al Rosen
F
Location requirements of the PRRC for the EU MDR
Replies
2
Views
144
fialor
D
Has anyone undergone a BARDA (HHS) audit as part of their grant process?
Replies
0
Views
67
DonnaLPG
T
Series A ready company - Term for medical devices companies?
Replies
2
Views
140
Ajit Basrur
M
IVD Registration - Use of Prospective Study Data
Replies
1
Views
110
Mallappa
S
Medical Device Research Use Only (RUO) label
Replies
2
Views
229
SANE
Ajit Basrur
Any recommended courses to FDA and CBP Import Process?
Replies
0
Views
89
Ajit Basrur
S
Is Lot Number required in addition to UDI serial number?
Replies
0
Views
94
SGquality
Sidney Vianna
Medical Device News International exposé of the harm caused by poorly tested medical devices.
2
Replies
12
Views
633
Sidney Vianna
C
Attestation of QA certificate from foreign (EU) Notified Body
Replies
6
Views
262
catechol
J
How important is using the "correct" GMDN?
Replies
4
Views
218
moounir
K
Moist Heat Sterilization worldwide Requirements and Regulations
Replies
1
Views
110
planB
J
INMETRO process of Hypodermic Needle in Brazil
Replies
1
Views
126
Marcelo Antunes
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