MRA EU-TGA Product Registration to EU Market

N

Nash27

Involved In Discussions
We are planning to register medical devices to European market Under the MRA (Mutual Recognition Agreement- TGA Australia and EU). Could you someone give a brief description on critical components that we need to ensure compliance with EU MDD requirements. Our initial pathway shall be as below;

• Selection of an EU representative
• Amending the post market surveillance and other relevant OP’s to meet the EU MDD requirement covering adverse event report notification, product advisory notices and product recalls.
• Compliance with Essential Requirements
• Amendment of label and IFU’s to meet the EU MDD requirements.
• Internal Training associated with changes / new requirements

Beside this are there any critical points that we need to worry about. Any suggestions would be really helpful. Thanks
 
N

Nash27

Involved In Discussions
Just giving a feedback on my above post. The pathway described above is a standard procedure for the Australian manufactures who would like to take advantage of MRA (mutual recognition agreement). One thing I would like to add above, the manufacturer need to demonstrate that substantial product realisation activities are carried out in Australia or New Zealand. How you demonstrate is up to the manufacturer.

If you have any further queries on this post I am happy to assist.:thanx:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P IATF16949 External Lab Calibration -CIPM MRA IATF 16949 - Automotive Quality Systems Standard 1
J 7.1.3.5.2 External laboratory - CIPM MRA IATF 16949 - Automotive Quality Systems Standard 3
H Regarding the validity of EMC & Safety test reports without NABL & ILAC-MRA mark. CE Marking (Conformité Européene) / CB Scheme 2
L MRA between EU and Switzerland - 1/2021 EU Medical Device Regulations 2
dinakim_zv CB report or ILAC-MRA report ISO 17025 related Discussions 11
Y Switzerland and EU Mutual Recognition Agreement (MRA) - What to do? CE Marking (Conformité Européene) / CB Scheme 1
N CE Marking Checklist Technical File Under MRA EU Medical Device Regulations 5
Hershal PJLA invited to join APLAC MRA General Measurement Device and Calibration Topics 8
Hershal Congratulations to L-A-B - Invited to join the APLAC MRA as a Signatory Body General Measurement Device and Calibration Topics 5
Hershal NVLAP notice - NVLAP Withdraws from the NACLA MRA General Measurement Device and Calibration Topics 2
L Australian TGA Device Reclassification Other Medical Device Regulations World-Wide 2
D TGA approved Gummy Vitamin (Pastille) Manufacturer Manufacturing and Related Processes 0
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
J TGA CER Other Medical Device Regulations World-Wide 4
L TGA Requirements Other Medical Device Regulations World-Wide 1
A TGA - Annual Report or Periodic Safety Update Report? Other Medical Device Regulations World-Wide 0
S Australia TGA Clinical Evaluation Report (CER) 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 – 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
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

Similar threads

Top Bottom