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Consultation: Designation of Australian conformity assessment bodies for medical devices - Implementation
This consultation closed on 11 January 2017.
The TGA sought comments from interested parties on the consultation paper for accelerated assessment of medical devices - Priority Review pathway - Implementations.
- Consultation: Designation of Australian conformity assessment bodies for medical devices - Implementation (pdf,302kb)
- Consultation: Designation of Australian conformity assessment bodies for medical devices - Implementation (docx,157kb)
Document released for consultation on Wednesday, 16 November 2016.
Interested parties should respond by close of business Wednesday, 11 January 2017.
Publication of consultation responses Wednesday 14 June 2017.
Feedback will be released following consideration of submissions. (See 'What will happen').
About the consultation
The Expert Panel Review of Medicines and Medical Devices Regulations 2016 includes regulatory reforms for medical devices to expedite assessment of certain medical devices that are identified as 'novel' using a priority review pathway.
In response to the reforms to establishment a priority review pathway, this paper provides, for public consultation, the proposed criteria for what constitutes a 'novel' medical device and an approach to implementation. The priority review pathway will require medical devices to meet the essential principles, including clinical evidence requirements, while expediting assessment through administrative changes. Development of this pathway also will require the establishment of business process for applications for priority review status. The consultation paper outlined proposed business processes and timeframes.
An overview of submissions and copies of submissions received are available at: Submissions received: Accelerated assessment of medical devices - Priority Review pathway submissions.
Any questions relating to submissions should be directed to the Business Improvement and Support Section, Director by email to firstname.lastname@example.org or by telephone to our information line on 1800 020 653.
What will happen
Following consideration of submissions, a finalised implementation document will be published on the TGA website.
The TGA is currently considering all submissions that were received as part of this consultation. The TGA thanks those who took the time to make a submission and to make comments and suggestions.
Further information will be provided as it becomes available.
- 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.