TGA Guideline for Dental Practioner and Dental Technicians about CMMD/PMD
, by Kevin Park
*Updated on 22/09/2024
Disclaimer:
- Please note the publication date of this blog post, as the information provided may become outdated over time.
- The content has been gathered from the Therapeutic Goods Administration (TGA) and summarized. While we strive for accuracy, it is your responsibility to verify the information's correctness and applicability to your practice.
- While we strive for accuracy, I can make mistakes. It is your responsibility to verify the information's correctness and applicability to your practice. Please contact regulartory affairs consultants for better advice.
The article summay
4 examples for dental practioners
- Dental practioner sending cases to local dental lab and overseas dental lab
- Dental practioner making own crowns with Austrlalian sponsor supplied material and purchased from overseas
- Dental practioner 3d printing surgical guides with Australian sponsor supplied resin and purchased from overseas
- Dentist using orthodontic devices with Australian sponsor supplied and purchased from overseas
How to look up TGA registered product
How to report medical device related events
3 Cases for dental laboratories
- CMMD supplied on or before 25 February 2021
- CMMD Supplied after 25 February 2021
- CMMD manufactured overseas
TGA related Important definitions you should know
- Sponsor: In relation to therapeutic goods, means: a person who exports, or arranges the exportation of, the goods from Australia; or a person who imports, or arranges the importation of, the goods into Australia; or a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who: exports, imports or manufactures the goods; or arranges the exportation, importation or manufacture of the goods; on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia. In relation to a medicine, means the person in relation to whom the medicine is included in the ARTG. In relation to the recall of therapeutic goods, the sponsor also includes the person to whom the goods are on, or cancelled or suspended from the ARTG; or supplying exempt goods; or illegally supplying goods or manufacturing goods.
- Manufacuturer: Corporation or person carrying out one or more of the steps specified in the definition of manufacture
- ARTG: The Australian Register of Therapeutic Goods
- CMMD: Cusom made medical devices
- PMD: Personalised medical devices
- Source: https://www.tga.gov.au/resources/acronyms-and-glossary-terms
For dental practioners - dentists and dental prosthetists
Example 1. Tashina - Dental practioner sending cases.
Tashina, an AHPRA-registered dental practitioner, sends patient casts to an Australian dental laboratory to create personalized occlusal splints. If the laboratory uses materials included in the Australian Register of Therapeutic Goods (ARTG), the splints are exempt from ARTG registration.
However, if the laboratory uses materials not included in the ARTG, it becomes the sponsor and must register the splints. Tashina is not responsible for this registration.
If Tashina sends casts to an overseas dental laboratory and imports the splints back into Australia, she will then be considered the sponsor and must register the devices in the ARTG prior to importation.
Example 2. Amir - Dental practioner making her/his own crowns
Amir, an AHPRA-registered dental practitioner, creates crowns using millable blocks or discs purchased from an Australian-based supplier who has included these materials in the Australian Register of Therapeutic Goods (ARTG). Since the materials are ARTG-approved, Amir is the sponsor of the finished crowns, which are exempt from ARTG registration.
Despite this exemption, Amir must still fulfill several regulatory obligations, including:
- Providing instructions for use
- Meeting the Essential Principles
- Reporting adverse events
- Complying with advertising requirements
If Amir imports millable blocks directly from overseas, he becomes the sponsor of both the blocks and the crowns made from them. He must register the imported millable blocks in the ARTG before importing them. However, the crowns made from these registered blocks will remain exempt from ARTG inclusion, and he must continue to meet the same regulatory obligations.
Example 3. Maya - Dental practioner, 3D printing surgical guide
Maya, an AHPRA-registered dental practitioner, utilizes a 3D printer to create various dental devices. The 3D printer itself is not classified as a medical device and does not require inclusion in the Australian Register of Therapeutic Goods (ARTG).
When Maya 3D prints a dental surgical guide using resin sourced from an Australian supplier, which is included in the ARTG, the guide is exempt from ARTG registration.
However, Maya intends to use a new resin from an overseas supplier for dental devices. Upon importing this resin, she becomes the sponsor and must include it in the ARTG. The surgical guides made with this newly registered resin will also be exempt from ARTG inclusion. Nevertheless, Maya must still adhere to several regulatory obligations, including:
- Supplying instructions for use
- Meeting the Essential Principles
- Reporting adverse events
- Complying with advertising requirements
Example 4. John - Dentists using orthodontic medical devices
John, an AHPRA-registered dentist, purchases brackets and wires from an Australian-based supplier who has included these materials in the Australian Register of Therapeutic Goods (ARTG). The braces he assembles for his patients are part of his clinical practice and do not require ARTG registration, as John is not the sponsor of a medical device.
However, if John imports brackets and wires for assembling braces, he will become the sponsor and must include these materials in the ARTG prior to importation.
If you want to see full article about this, please click here to see.
(https://www.tga.gov.au/resources/resource/guidance/guidance-dental-practitioners)
ARTG Look Up
Search your products and overseas dental laboraties from the TGA, please click here. (https://www.tga.gov.au/resources/artg)
Or please ask your suppliers to provide ARTG certificates about their products.
Report medical device incident or adverse event
If there is/are
- multifactorial causes, mechanical or material failure
- design issues
- labelling, packaging or manufacturing errors
- software deficiencies
- device interactions
- user/systemic errors
For dental laboratories
Case 1. Local dental laboratory on or before 25 February 2021
If you supplied on or before 25 February 2021, please submit the TGA CMMD notification, click here for the guide. (https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf)
If you provide a transition notification for your eligible PMMD before 1 November 2024, you can continue supplying your devices without an ARTG inclusion until 1 July 2029.
Case 2. Local dental laboratory after 25 February 2021
If your PMMD entered the market after 25 February 2021, it will not qualify for transition and must be included in the ARTG before it can be supplied.
Case 3. CMMD manufactured overseas
If you are suppying overseas dental applicaitons, you are the sponsor. Please follow the instruction from page 8 of the TGA CMMD notification guide.
Closing
I hope this information provides valuable information for you, your patients, and customers. Please take a moment to review the instructions, guidelines, and disclaimer to ensure clarity and accuracy.
At CM Medical, we are dedicated to upholding the regulations established by the Therapeutic Goods Administration (TGA) and are committed to providing top-quality products with accurate and trustworthy information. Should you need further assurance, please don’t hesitate to request TGA certificates for any of our products.
Thank you for your time and dedication to upholding the highest standards in dental care.