TGA regulations and ISO 13485:2016 gap analysis MDSAP

Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
The QMS requirements defined in the Therapeutic Goods Regulations 2002, Schedule 3 Conformity Assessment Procedures, Part 1, are pretty basic, similar to the MDD requirements.

I have not performed a formal gap analysis, but found this information instead:



"In Australia, ISO 13485:2003 is formally recognised under the Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008, made for the purposes of section 41DC of the Therapeutic Goods Act 1989, as a standard for the manufacture of all kinds of medical devices that require a quality management system for conformity assessment. Quality management systems that comply with the ISO13485:2003 standard are treated as complying with the relevant parts of the conformity assessment procedures for Quality Management Systems set out in the Therapeutic Goods (Medical Devices) Regulations 2002.
Prior to the end of the transition period the TGA anticipates to update the relevant Conformity Assessment Standards order to reference the newer ISO13485:2016.
In the interim, the TGA will continue to recognise audits based on ISO13485:2003 for the period indicated on the associated certificate, however these certificates must expire no later than 1 January 2019 (aligning closely with the end of the ISO transition period on 1 March 2019).
Audits based on ISO13485:2003 will continue to be conducted by the TGA until 1 January 2019 unless the manufacturer elects to use the newer standard. Audits performed by the TGA under the EU-AU Mutual Recognition Agreement (MRA), as a Conformity Assessment Body, will be carried out against EN ISO13485:2012 or EN ISO13485:2016 as required by the EU Commission."


URL:

https://www.tga.gov.au/node/729862
 
Thread starter Similar threads Forum Replies Date
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
bio_subbu Australia?s TGA - IVD Regulations have been published Other Medical Device Regulations World-Wide 0
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
M Informational TGA presentation: Cybersecurity for medical devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
M Informational Australia – TGA business plan 2019-20 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Essential principles checklist (medical devices) Medical Device and FDA Regulations and Standards News 2
M Informational TGA – Webinar: The cybersecurity of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
M Informational TGA Webinar: Essential Principles to software Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device patient information leaflets and implant cards Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: Digital Devices Webinar 3, 20 June 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device cyber security guidance for industry Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Australian TGA Sponsor costs Other Medical Device Regulations World-Wide 3
M Informational TGA presentation: How the TGA regulates software, 7 March 2019 Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Action Plan for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
C Sponsor Agreement Requirements for Australia TGA Other Medical Device Regulations World-Wide 7
A Australia TGA Medical Device Sponsor Agreement - Example or Template Other Medical Device Regulations World-Wide 13
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Brexit – Implications for therapeutic goods in Australia Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Good Clinical Practice Inspections Program Medical Device and FDA Regulations and Standards News 0
M Informational Webinar: The role of the TGA in digital health Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M TGA comparable overseas regulators requirements matrix? Other Medical Device Regulations World-Wide 0
M TGA Disinfectant Wipes Registration Registrars and Notified Bodies 2
S Question about Australia - TGA and MDSAP - Technical file ISO 13485:2016 - Medical Device Quality Management Systems 3
N MRA EU-TGA Product Registration to EU Market EU Medical Device Regulations 1
F Looking for Australian Sponsor for an impending TGA Submission Other Medical Device Regulations World-Wide 8
V Study About Raw Materials (Polymers) - DSC, FTIR,TGA, and SEM Images Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M TGA Transition to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 0
S Is TGA approval required for a ARTG listed IVD for a sample type addition? Other Medical Device Regulations World-Wide 11
N DEHP/DHP Labeling Requirements TGA Other Medical Device and Orthopedic Related Topics 2

Similar threads

Top Bottom