ROW Approval Matrix

Dobby1979

Involved In Discussions
#1
Hi All.

I am trying to find some information on the regulatory approval required for countries around the world, notably Australia and Canada at the moment. Does anyone have any kind of simple matrix that demonstrates the complexity involved with different countries? Do they favour 510(k) or CE Marking etc?

Any help is welcome.

Thanks.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
You can leverage EC certification (CE marking) or a cleared 510k to fast-track clearance in Australia (the former more than the latter). You'll find all the details on the TGA's website.

No offence, but the Y in DIY means "Yourself".
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur Need help in Conditional Formatting for the entire row Excel .xls Spreadsheet Templates and Tools 3
smryan How to reference a row from a cell value in Excel? Excel .xls Spreadsheet Templates and Tools 2
O Need to Create Macros so that it can copy data to the next row.... Excel .xls Spreadsheet Templates and Tools 5
Ajit Basrur How to get entire row in MS Excel colored? (Conditional Formatting) Excel .xls Spreadsheet Templates and Tools 5
L Turning one continuous row to columns in Excel 2007 Excel .xls Spreadsheet Templates and Tools 4
Marc Rut Row - Water running low in LA - What does this mean? Feb 2008 World News 0
C SPC Chart Run Rules - 7 in a row vs. 8 in a row Statistical Analysis Tools, Techniques and SPC 3
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
F How to fill out an Appearance Approval Report (AAR) APQP and PPAP 0
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Medical devices_hong kong_post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
C AS9145 Appendix D PPAP Approval Form APQP and PPAP 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Can Brazil approval be used for other countries in Latin America? Other Medical Device Regulations World-Wide 2
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
DuncanGibbons FAA approval of articles (PMA, TSO) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
M Criteria and when to carry out Setup Approval Manufacturing and Related Processes 5
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K ISO 9001 Requirements for Raw Material Supplier Assessment and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
M Informational USFDA Guidance – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Medical Device and FDA Regulations and Standards News 0
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
S FDA approval process for medical device US Food and Drug Administration (FDA) 2
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J IEC 62366 - Ethical approval IEC 62366 - Medical Device Usability Engineering 5
H Informational What is PPAP (Production Part Approval Process)? APQP and PPAP 22
C Approval of raw material suppliers which do not manufacture the material ISO 13485:2016 - Medical Device Quality Management Systems 7
S MDD in 2018 - Company with no previous EU approval EU Medical Device Regulations 1
V Paint batch approval procedure for automotive industry Manufacturing and Related Processes 6
S STPi approval for laptop movement IEC 27001 - Information Security Management Systems (ISMS) 1
R Concessions - ISO 13485:2016 requires concession approval from customers Nonconformance and Corrective Action 2
K Where are Production parts approval specified/required? Misc. Quality Assurance and Business Systems Related Topics 2
E Approval for Templates Document Control Systems, Procedures, Forms and Templates 6
T Stamps vs Signatures - Stamps as inspection/approval sign-off vs. Initials Records and Data - Quality, Legal and Other Evidence 18
S If a piece of software receives approval as part of a medical device system Canada Medical Device Regulations 5
C %GRR <10% not possible. How to get approval by auditor? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
Ajit Basrur CDRH Premarket Approval Application Critical to Quality Pilot Program US Food and Drug Administration (FDA) 0
A AS9100D, Clause 8.4.1.1 - External Provider Scope of Approval AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
Similar threads


















































Top Bottom