List of Regulated Countries - Registrations on Medical Devices Class I / II / III

L

Louane

#1
Hi, I am searching for a list of the countries being fully regulated / semi regulated and low regulated for all registrations on medical devices class I / II / III, would anyone be able to help? Thank you for your help
 
Elsmar Forum Sponsor
L

Louane

#3
Thank you so much Rob!! I have indeed checked the medical device regulations worldwide and it gave me a good background but I needed a bit more. Your help is gretaly appreciated!! and I will use your file for my project.

Again many thanks
 
Thread starter Similar threads Forum Replies Date
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 8
D List A IVD - Change to material supplier EU Medical Device Regulations 3
M Sites to List on Multi-Site Certifications Registrars and Notified Bodies 1
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
G Assignable cause/corrective action list for SPC Software Statistical Analysis Tools, Techniques and SPC 3
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Forms Master List versus Record Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
K List of Deregulated Devices in Mexico Other Medical Device Regulations World-Wide 2
G Harmonized List - MDD 93/42/EEC Other ISO and International Standards and European Regulations 2
M EU – REACH Authorisation Decisions List REACH and RoHS Conversations 0
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 0
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational EU – Candidate List of substances of very high concern for Authorisation Medical Device and FDA Regulations and Standards News 0
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
P List of ISO certificate registrars around the world - ISO certification databases ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Informational US FDA – Priority List of Patient Preference-Sensitive Areas Medical Device and FDA Regulations and Standards News 0
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
T Medical device Clinical trial exemption list China Medical Device Regulations 2
D China - Where I can get NMPA complete structure/organogram chart and GB/YY format list China Medical Device Regulations 1
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
eule del ayre List of Level 3 PPAP requirements for automotive suppliers APQP and PPAP 20
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
M Is there a published List of AIAG members requiring IATF certification ? IATF 16949 - Automotive Quality Systems Standard 2
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
G Where to list chain of traceability? ISO 17025 related Discussions 6
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
F Design check list for Cable and Wiring Harnesses Manufacturing and Related Processes 6
P Template or example Excel list of ISO certificates issued to clients ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Docs for Medical Device registration in China - List of certificates China Medical Device Regulations 6
T List of Tests - IEC 61010-1, 3rd edition and IEC 60601-1, 3.1 edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
H IS there any database for list of CE marked Medical devices and there current status EU Medical Device Regulations 8
B Are contingency plans required to list the sources of alternate products or services? IATF 16949 - Automotive Quality Systems Standard 2
N What should be included in the supply contract - Annex 2 list B IVD ISO 13485:2016 - Medical Device Quality Management Systems 6
A AS9100 Rev D - List of Required Procedures Document Control Systems, Procedures, Forms and Templates 5
Q Product Instruction for Use Manual (IFU) - Obligation to list the standard used 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Who compiles the Critical Component List, Insulation Diagram etc.? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
M EN Standard (ETSI EN 301 489-3 v1.6.1) is Harmonized but not on Europa List Other ISO and International Standards and European Regulations 3

Similar threads

Top Bottom