July 7th 2021

TGA Registration of Personalised Medical Devices

Please find attached a copy of communication from  Dr. Scott Davis who is a Prosthodontist (Port Macquarie and Coffs Harbour), member of AANZP, sitting on the Federal  ADA committee.




    

There have been a series of meetings with TGA in the last couple of weeks and the new discussion paper they released as well since we last talked.

The name of the document released by TGA earlier this month is:

"Consultation: Proposed refinements to the regulation of personalised medical devices". Version 1. Version 2 should be released within two weeks however only minor changes that are not significant.

What does all this mean for Australian Prosthodontists and dental technicians? If you accept that some degree of regulatory change was going to happen regardless then the refinements have been surprisingly significant.

There have been several concessions proposed by the TGA to their original stand on these matters, that will reduce the regulatory cost and administrative burden both for dentists and technicians.

Primarily there are three main areas of change: Exclusions from the ARTG for some devices. Exemptions from the usual regulatory requirements for some devices. Finally inclusion in the ARTG through alternative conformity assessment procedures for some devices.

1) Exclusions mean that these devices would not be on the ARTG. This may include impressions and models cast from these, anatomical models manufactured for educational purposes, mouthguards for sport, bleaching trays, polymers and resins used in the manufacture of medical devices. There are still ongoing discussions on models used for purposes other than education.

2) Exemptions are a little more nuanced and the final deliberations have not been made. Essentially this is when it can be demonstrated that the risks associated with the manufacture and use of the device can be adequately managed. For dentists we have AHPRA registration so the process is simple but for technicians it is still being ironed out as to what qualification or membership of a particular group will allow for exemption. Essentially if the device is 'prescribed' by a registered practitioner it should meet the requirements. These changes are for Class 1 items (low risk) not class2 (medium risk).

This will most likely include dentures, occlusal splints, aligners. Other items may be included with further versions of the consultation paper and draft final document.

3) Conformity assessment. Currently any item that is in the mouth continuously for more than 30 days is a Class 2a or above. That means third party conformity assessment and a significant cost ($30,000-$100,000 depending on the range of items made). Being able to achieve alternate conformity with self assessment and a cost closer to $1,500 is a potential more favourable outcome being negotiated. There is still work to be done on exactly how this will work and what is included. Any fixed dental restoration is considered Class 2a and as such either the dental technician or the dentist who makes their own devices will benefit from the proposed changes.

The ADA with others is working hard to have Global Medical Device Nomenclature numbers (GMDN's) reduced from the current 64 to just 5, and these five will describe all medical devices in dentistry with overarching numbers rather than every single item having a unique number. Since each one you produce would cost $1,500 it will also be a big step forward.

More work to do between now and the end of August and hopefully more positive updates for you all by then.

Scott Davis

BDS MDSc FRACDS MRACDS (Pros) FPFA FICD FADI DICOI

Prosthodontist

Port Macquarie and Coffs Harbour

NSW   Australia


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