(24/08/2021 Updated) Changes to the Regulation of Custom-made Medical Devices (Dental Clinic & Laboratory)
by Kevin Park
NEW Update (24/08/2021)
According to the latest announcement by TGA, ADA and ADIA,
If you are a:
healthcare practitioner who manufactures a specific device as a component of your clinical practice; or
an entity who manufactures specific devices for a healthcare practitioner as a component of their clinical practice,
you will not be required to register your devices for transition or include them in the ARTG if you are making them from an ARTG-included material or component (s).
Next steps While this instrument focuses predominantly on materials and components used in the dental sector, feedback from peak professional bodies and Ahpra indicates this approach to regulation may be appropriate for materials and components, and the devices made from them, in other sectors. We will continue to engage with these sectors, both directly and through peak professional and industry bodies, to identify further products that would be more appropriately regulated in this manner. Further outcomes from the public consultation will be progressed and communicated as they develop.
**Disclaimer** The information on this blog is combined my opinions and facts. I will mark '(My Opinions)' in the beginning of sentences if is is not fact. Please understand consequences of using this information are your responsibility. Thank you.
TGA emailed 'Changes to the regulation of custom-made medical devices' to dental technicians including dental clinics, but many of them did not receive it yet.
Custom-made medical devices has been exempted up to now.
But On 25 February 2021, the definition of a custom-made medical device will change.
You will have time by 1 November 2021 to submit evidence of conformity assessment and inclusion in the ARTG .
(IMPORTANT) If your device is required to be included in the ARTG and you do not submit a transition notification form before 25 August 2021 you will not be able to continue supplying the deviceuntil you have a valid inclusion in the ARTG.
**How to submit a transition notification form
Access here. Click here to go.. https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/
Fill the basic information - your name and details
On #3. Sponsor vs. Manufacturer (My Opinion) Manufacturer
On #4. Kind of medical device - Please write all dental lab services that you are providing currently as many as you can to cover all of your works. -(My Opinion) dental teeth restoration, splint, denture, implant superstructure, temporary restoration and multiple patient-matched Class 1 and Class IIa devices requested by dental practitioner or for treatment purpose
On #5. Purpose of medical device - (My Opinion) The medical device is designed to restore natural teeth's function and aesthetics based on dental/medical professionals instructions, fabricated according to conventional impression or digital impression of patients. (Please add or change to describe for your services.)
On #6. GMDN Code - GMDN code is 'Global Medical Device Nomenclature'. - CT998 – Dental/Maxillofacial devices
On #7. Classification - (My Opinion) Please choose 'Class IIa'. -Usually permanent dental implant is Class IIb. -Dental gloves and masks are Class I.
On #8. No
On #9-10. Not applicable
On #11-12. Your information
On #13. Declaration -Done.
(My Opinion) TGA is not targeting specific groups or medical devices, they are kind enough to educate and advise with guidelines. (I believe..) Now they are updating medical device guidelines for new technology product - 3D printing, medical software and more. Yes, there will be more paper works, but it will help us. It would be hard to send dental crowns to overseas.
**My Recommendations for dental clinics/laboratories to prepare
(My Opinion) If possible, please prepare extra works to keep data.
If you use accounting software to make invoices, please write patients name, dentist name on invoice at least.
If you use dental crown design software like Exocad, please use full name of patients and dentists name to find them easily when you need.
Please keep all lab order sheets in the end of each month.
Please use TGA registered product. If you are not sure, you can search. Click here to go..
**Once again, this article has facts and my opinions, please understand consequences of using this information are your responsibility. This blog is written on 13/03/2021 and updated 22/08/2021. All information will be different when you check.