TGA Transition to ISO 13485:2016

Thread starter Similar threads Forum Replies Date
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 – European implementation of Medical Device and IVD Regulations – Implications for Australia 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
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
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
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
N TGA CA Certificate approved suppliers ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom