Consultation: Alignment with European medical device regulatory framework
Up-classification of surgical mesh & Patient implant cards
This consultation closes on 25 August 2017.
Invitation to comment
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed changes to:
- up-classify surgical mesh from Class IIb to Class III; and
- require provision of patient medical device ID cards (patient implant cards) to patients.
These two actions seek to further align Australia's medical device regulatory framework with European Union medical device regulations as part of the implementation of Recommendation 20 of the Medicines and Medical Devices Review.
- Consultation: Alignment with European medical device regulatory framework (pdf,201kb)
- Consultation: Alignment with European medical device regulatory framework (Microsoft Word,107kb)
Document released for consultation on Friday, 28 July 2017.
Interested parties should respond by close of business Friday, 25 August 2017.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA is seeking comments on two measures to further align Australian and European medical device regulatory requirements:
- Reclassification of all implantable surgical mesh medical devices from a Class IIb (medium to high risk) to Class III (high risk); and
- Introduction of formal requirements for medical device manufacturers to provide patient implant cards and product information for all active and implantable medical devices.
The TGA is looking for views from industry, healthcare professionals, and current (and future) recipients of medical devices on the proposed implementation approach for these changes. Comments will assist the TGA to identify issues, and address any unintended consequences, to inform the proposals and the regulatory amendment process.
On 15 September 2016, the Australian Government accepted 56 of the 58 recommendations from the Expert Review of Medicines and Medical Devices Regulation. One of the recommendations was to align (wherever possible) the Australian regulatory framework with the European Union in respect of the:
- Classification of medical devices;
- Essential Principles/Requirements;
- Adoption of a risk-based approach to variations to medical devices.
Content of submissions
The consultation paper includes a 'questions' box at the end of each section, with examples of questions for stakeholders to consider. Submissions may address any, or all, of these questions directly, or address any issues that may arise out of the regulatory changes:
- Up-classifying surgical mesh to class III.
- Patient implant ID cards.
- Patient medical device information.
- Implementation issues.
In addition, submissions might include:
- Suggestions to improve implementation.
- An assessment of how the proposed change will affect you or your organisation.
- What you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.
How to submit
Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.
Hardcopy submissions with a printed cover sheet may be mailed to:
Business Improvement and Support Section
Medical Devices and Product Quality Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed to the Director, Business Improvement and Support Section by email to firstname.lastname@example.org or by telephone to our Medical Devices information line on 1800 020 653.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website. Once finalised, the regulatory changes and implementation arrangements will be published on the TGA website.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- Seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.
Further information on the Government's response to the MMDR recommendations is available at Medicines and Medical Devices Regulation review.