The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide medical device manufacturers, healthcare professionals, and other parties involved with additional recommendations and clarifications regarding the applicable regulatory framework.

Regulatory Background 

First, the authority mentions that earlier in February 2021, the new regulations for custom-made medical devices entered into force. Since the definition of a custom-made medical device has been amended, a wide range of products previously falling within the scope of exemption is now required to be included in the Australian Register of Therapeutic Goods (ARTG). However, a transitional period has been introduced. Manufacturers and importers of medical devices falling within the scope of the new rule must achieve compliance with the new regulatory requirements before November 1, 2024. For this purpose, they should pass a special registration. The registration should be completed before August 25, 2021. 

Notification Rules 

In the case of custom-made medical devices, a notification procedure should be applied. Under this procedure, the responsible party (local medical device manufacturer or a supplier importing medical devices from abroad) should notify the regulating authority no later than two months from the date the medical device in question was manufactured or placed on the market. The appropriate notification should be filed via a special online form. Should the responsible party fail to notify the regulating authority in time, the latter is entitled to impose additional fines and penalties. 

Once the notification form has been submitted, the applicant will receive its copy via the email indicated therein. The same email will be used for all further communications between the regulating authority and the applicant. Thus, in case of any changes to contact details, an applicant shall duly notify the authority in order to ensure effective communications. 

When completing the aforementioned online form, the applicant will have to provide the following information:

  • Manufacturer details (name and address);
  • GMDN Code for the device(s);
  • Classification of the device(s); and
  • A description of the device(s). 

If the party submitting a notification is a local medical device manufacturer, it will also be the sponsor of all medical devices it manufactures. Each kind of medical device requires a separate notification form to be submitted. 

Definition of a Custom-Made Medical Device 

The initial definition of a custom-made medical device is set forth in the Therapeutic Goods (Medical Devices) Regulations 2002. The authority also mentions that the scope of this definition excludes patient-matched, adaptable, or other mass-produced medical devices. The TGA also refers to the appropriate guidance on personalized medical devices. The notification also outlines the criteria to be applied in order to determine if a medical device in question is not a custom-made medical device. These criteria include the following:

  • The device complies with certain standards prescribing the way it should be designed or manufactured;
  • All the devices are manufactured on the basis of the consistent methodology;
  • All the devices are accompanied by the same instructions for use. 

The TGA additionally emphasizes that even if custom-made medical devices are not subject to mandatory inclusion in the national register of healthcare products, they still should be regulated under the medical device framework. According to the applicable regulatory requirements, the responsible parties shall:

  • Duly notify the regulating authority about manufacturing or importing such products;
  • Comply with any and all applicable requirements in terms of inspections and reviews;
  • Comply with the requirements on record keeping;
  • Provide all necessary information together with the device placed on the market;
  • Submit annual reports to the regulating authority in accordance with the applicable timelines;
  • Abstain from advertising custom-made medical devices directly to customers. 

Apart from the aspects mentioned above, the responsible parties should also achieve and sustain compliance with the applicable Essential Principles, as well as the requirements on advertising and reporting. For instance, all implantable medical devices should be accompanied by implant cards. 

Supervision 

The document also describes the authorities of the TGA in terms of post-market surveillance. According to the applicable legislation, the regulating authority is entitled to request additional information and carry out on-site inspections. 

The notice describes in detail all corresponding obligations of the custom-made medical device manufacturers and importers, namely:

  • Permitting authorized persons to enter and inspect the site, irrespectively of whether it is located in Australia or abroad. In the course of such an inspection, an authorized person is entitled to take all necessary measurements and perform testing. Additionally, he/she is allowed to take pictures and or/recordings. 
  • Provide additional documentation. The TGA is entitled to request the entity subject to inspection to provide additional documentation related to the medical device. In particular, the authority may require a copy of the request describing the custom-made medical device as provided by the healthcare professional, additional information accompanying the product, and evidence of conformity assessment documentation. 

Under the general rule, on-site inspections are usually carried out in response to incidents related to custom-made medical devices. In general, the regulating authority will notify the responsible entity subject to inspection 2 weeks in advance for local entities and in 4 weeks for foreign ones. However, in the case of investigations related to serious adverse events, the actual notification timelines could be different. 

Information Related to Custom-Made Medical Devices 

In accordance with the applicable record-keeping requirements, the medical device manufacturers and importers of custom-made medical devices are obliged to keep the records related to the products they are responsible for not less than 5 years for non-implantable medical devices, and not less than 15 years for implantable ones. 

The scope of information to be kept by the responsible party shall cover the following:

  • The statements contained in the information accompanying the custom-made medical device,
  • All annual reports,
  • Confirmation that the product complies with the applicable Essential Principles, 
  • Any documentation that could be reasonably necessary for the TGA to assess the aspects related to the safety and performance of a custom-made medical device in question. 

The document also outlines the scope of information to be provided by the manufacturer of a custom-made medical device when making it available on the market. According to the present TGA notice, such information shall include:

  • Information about the medical device manufacturer, including its name and address;
  • Information about the custom-made medical device itself;
  • Indication that the device is intended to be used only for a particular person, as well as the name of this person;
  • Information about the healthcare professional who has requested the device;
  • Information about the specific features of the medical device;
  • Confirmation of compliance with the applicable Essential Principles, or sufficient justification of non-compliance with some of them. 

Such a statement should be provided in writing, signed, and dated by the responsible person. 

In summary, the present TGA notice describes the regulatory requirements the custom-made medical devices should comply with under the new framework. The document highlights the most important aspects related to the inspections the authority is entitled to carry out, as well as the information to be provided together with the device. 

Sources:

https://www.tga.gov.au/custom-made-medical-devices 

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