Global market registration requirements for IVD's

D

Dr RA

Involved In Discussions
#1
#1
Hi

Can someone help me find a web site for Global market registration with duration, requirements and supporting regulation and quality compliance including the reference site and forms for registration and sales please.

Many Thanks
RA
:thanx:
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
I think that such a website would only exist in a perfect world... :) I'm not aware of one.

Providing such condensed information is what consultants like me do for a living :eek:

You could check the Emergo group website though. It might have most of the information you need but not on a single page or a matrix, so you'll still have to do some collecting. I don't have any affiliation with Emergo.

Cheers,
Ronen.
 
Last edited:
D

Dr RA

Involved In Discussions
#3
#3
Thanks Ronen,

I was ready for the answer in my mind, but still wanted to confirm, bit greedy if I could get something around. I have gone through Emergo site.

Thanks again
RA
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Directory of Largest Global Certification Bodies (Accredited) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Sidney Vianna Informational IAF and ILAC to merge. A Global Accreditation mammoth? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
L Global distributor vigilance responsibility Medical Device and FDA Regulations and Standards News 14
J Getting training either from ASQ or from SAI Global - ISO 9001 Lead Auditor training Training - Internal, External, Online and Distance Learning 1
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
M Informational Fourth WHO Global Forum on Medical Devices REPORT Medical Device and FDA Regulations and Standards News 0
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
qualprod SAI Global Status as of July 2018 Registrars and Notified Bodies 2
S Regulatory Affairs Certification Exam (Global) Training - Internal, External, Online and Distance Learning 0
Sam Lazzara GS1 introduces Global Model Numbers for Medical Devices Other Medical Device Regulations World-Wide 2
T SAI Global - On sale again? (2017) Registrars and Notified Bodies 8
A Global Medical Device Quality Compliance Overview Presentation - Help Wanted Other Medical Device Regulations World-Wide 2
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
S Compliance to GADSL (Global Automotive Declarable Substance List) RoHS, REACH, ELV, IMDS and Restricted Substances 4
L Corporate Manual - Global Multi-Site ISO9001:2015 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc Definition GDSN - Global Data Synchronization Network Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition GTIN - Global Trade Item Number Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
B Global / Local Management Review - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Support Group for Global Quality, Regulatory, and Trade Compliance Professionals Other Medical Device Regulations World-Wide 0
T OES Global Results Drift Quality Manager and Management Related Issues 1
Q Global SCAR Software System Recommendations Quality Assurance and Compliance Software Tools and Solutions 2
W RAC EU/Global focus certification - Study Group for Spring 2015 Professional Certifications and Degrees 4
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
J GHTF (Global Harmonization Task Force) SG2 Guidance Documents EU Medical Device Regulations 3
C Should I get an Internal Auditor Certification of Exemplar Global / RABQSA? Internal Auditing 17
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
R SAI Global puts itself up for sale Registrars and Notified Bodies 11
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
L Certification for new company global engineering office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Ongoing Cpk and Global/Historical Data Statistical Analysis Tools, Techniques and SPC 7
R RABQSA is now Exemplar Global ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 23
D RAC Regulatory Affairs Spring 2014 EU or Global Exam Study Group Professional Certifications and Degrees 15
x-files Global Timeline Plan of IMS/QMS Activities for a Thermal Power Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P Global 8D Problem Solving Training Material Problem Solving, Root Cause Fault and Failure Analysis 1
P Global 8D Problem Solving Example Problem Solving, Root Cause Fault and Failure Analysis 5
V The ASQ Global State of Quality Book, Video, Blog and Web Site Reviews and Recommendations 2
AnaMariaVR2 Creating Global Giants from a Culture of Israeli Start-Ups Coffee Break and Water Cooler Discussions 0
S Global Document Control SOP example Document Control Systems, Procedures, Forms and Templates 4
P Anyone have experience with GLOBAL GAP (Global Good Agricultural Practices)?? US Food and Drug Administration (FDA) 5
MarilynJ6354 American Global Standards Virtual Registrar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Integrating Multiple HSEQ Systems into a Single Harmonised Global System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Call for an Expert Speaker @ QuEST Global Career and Occupation Discussions 7
S Structuring a QMS with a Global Company Quality Manager and Management Related Issues 4
M Global Radio Frequency Regulations for Medical Devices Medical Information Technology, Medical Software and Health Informatics 3

Similar threads

Top Bottom