In the latest amendment on Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 on 23 July 2021, for inclusion of medical devices that contain medicines or materials of animal, microbial, recombinant or human origin as well as Class 4 IVD medical devices, the conformity assessment certification and audit requirements were changed to acceptance of relying on conformity assessment documents issued by European notified bodies in the application in Therapeutic Goods Administration (TGA).
Adopting one of the recommendations from Expert Panel Review of Medicines and Medical Devices Regulation (the Review), TGA has accepted the utilisation of overseas evidence (eg. marketing approvals or overseas assessment) for medical devices, including in vitro diagnostic medical device (IVD), from a comparable overseas regulator or assessment body.
What kind of overseas evidence that can be considered for the manufacturer in the application?
To go under the abridgement TGA conformity or audit assessments, the evidence issued within the range of the following overseas regulators and assessment bodies can be considered:
- - EC Certificate under Medical devices directives (MDD), IVD Directive (IVDD), Medical Device Regulation (MDR), and IVD Regulation (IVDR);
- - Jurisdiction decision of the United States Food and Drug Administration (US FDA);
- - Approvals issued by Health Canada;
- - Pre-market approvals issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB) in Japan;
- - Certificates and reports issued under the Medical Device Single Audit Program (MDSAP);
- - ISO 13485:2016 certificates (for IVD inclusion applications until 26 May 2023).
Manufacturers should be aware that the device must have the same design and intended purpose and be intended for the same indications. And the evidence provided should be issued by an overseas regulator or assessment body for the same medical device you are applying to have included in the Australian ARTG.
For more details on the abridgement of the TGA conformity or audit assessments, TGA has published a guidance for requirements regarding the documentation when manufacturers utilise overseas approvals or assessments in the application. In the following we highlight what the manufacturers need to pay attention to in the respective applications:
[A. The TGA conformity assessment]
The TGA conformity assessment is to assess whether the quality management system of a manufacturer is eligible to certain regulatory requirements and the manufacturer can demonstrate the compliance of their devices with relevant essential principles from the TGA. This means that the manufacturer’s audit report or product assessment/evaluation report may be supportive to abridge the TGA’s overall conformity assessment process by complying with the relevant requirements. If accepted through this way, certain amount of assessment of the application can considered to be reduced upon confirmation.
[B. Applications for the ARTG inclusion]
The inclusion process for medical devices in the ARTG, TGA has stipulated the regulation of Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, which specifies the documentation necessary to be provided in the application, in order to avoid the refusal of the preliminary assessment. It depends on the category and classification of the medical device that the manufacturers/sponsors can utilise the overseas evidence, which is required in the application to comply with the requirements, including Manufacturer Evidence and evidence of product assessment and both will need to be submitted prior to the application of the devices for inclusion in ARTG.