Worldwide device regulatory authorities at country level

Elsmar Forum Sponsor
L

locutus

Involved In Discussions
#3
#3
Agreed, good link Rob - most of it generally but gives a good perspective some developing countries and countries without a robust regulatory system.
 
rob73

rob73

looking for answers
#4
#4
I have tried a few of the links, not all work, but generally, for those that do not, you can copy the first part of the address and work from there to find the right department.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V Overview of the Medical Device Approval Process in Major Markets Worldwide Other Medical Device Related Standards 2
SteveK Medical Device Regulations Worldwide - Useful Whitepaper Other Medical Device Regulations World-Wide 3
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
K Moist Heat Sterilization worldwide Requirements and Regulations Other Medical Device Regulations World-Wide 1
A Selling our own class 1 (EU) devices worldwide - Who is responsible for registration? Other Medical Device Regulations World-Wide 7
R Number of UK (or worldwide) businesses certified. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
AnaMariaVR2 24hr Worldwide Air Traffic Simulation Federal Aviation Administration (FAA) Standards and Requirements 0
G ISO 9001 Worldwide Certification for a company with multiple world wide locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Survey or Statistics on the use of OHSAS 18001 Worldwide Occupational Health & Safety Management Standards 66
T Survey or Statistics on the use of the AS 9100 Standard Worldwide AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Requirements for Clinical Trials worldwide ISO 13485:2016 - Medical Device Quality Management Systems 2
Marc Toyota recalls nearly 1 million vehicles worldwide - Steering Shaft Assembly World News 1
Marc Manpower survey shows worldwide "talent shortage" Career and Occupation Discussions 6
Marc GM worldwide sales were at their highest level in 27 years World News 5
K Register of ISO 14001 Certified Companies Worldwide ISO 14001:2015 Specific Discussions 3
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 1
Aliken Fluoride sustained-release device Other US Medical Device Regulations 0
K Advertising and promotion of device under investigation China Medical Device Regulations 1
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
N Drawing tolerance vs. Measurement device General Measurement Device and Calibration Topics 4
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
C GUDID Device record history Medical Device and FDA Regulations and Standards News 2
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
A How to make sure whether the predicated device is marked with EC certificate? EU Medical Device Regulations 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1

Similar threads

Top Bottom