Many medical device (and IVDs) Sponsors provide the manufacturer’s conformity assessment certification issued by European Notified Bodies (EU NBs) to support their applications for marketing authorization in Australia.
To continue this marketing path, device manufacturers are working alongside their EU NBs to maintain current CE certifications of their products. However, the lack of sufficient NB designated under the MDR by May 2020 may have a ripple effect on ensuring a steady supply of their devices in Australia.
To help foreign manufacturers overcome this obstacle, on July 26, 2019, the Australian Authority Therapeutic Goods Administration (TGA) announced it will continue accepting valid EC Certificates issued in accordance with any of the Directives (MDD 93/42/EEC, IVDR 98/79/EC and AIMDD 90/385/EEC) until their expiry date or May 2024, whichever is the earliest.
The updated guidance (version 1.3) “Use of market authorisation evidence from comparable overseas regulators/assessment bodies for Medical Devices (including IVDs)” was also published on July, 26. It provides an overview of the modality employed by the TGA to assess the evidence and documentation issued by some foreign regulatory Authorities and Assessment Bodies (e.g. EU NBs, US FDA, Health Canada, PMDA and MDSAP Auditing Organizations), for example for the inclusion of Medical Devices and IVDs in the ARTG.
- CE Certificates issued by EU NBs;
- Approvals and licences issued by Health Canada;
- ISO 13485:2016 certificates issued by a certification body;
- Certificates and reports issued under the Medical Device Single Audit Program (MDSAP), provided that the Australian regulatory requirements must have been covered in the audit(s), and certificates must show that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.
TGA is prepared to issue the necessary amendments in Australia, should the current EU transitional arrangements prescribed in the MDR or IVDR abruptly change.