Recently, the Australian Medical Device Regulatory Authority (TGA) issued a statement announcing that the transition period for ISO 13485 certificates as evidence for manufacturers of in vitro diagnostic (IVD) medical devices has ended on May 26, 2023.

The statement stated that it will no longer be accepted after May 26, 2023:

1. ISO 13485:2016 certificate issued by a notified body designated by IVDD 98/79/EC;

2. ISO 13485:2016 certificate issued by an accreditation body that is a signatory to the International Accreditation Forum Multilateral Recognition Agreement (IAF MLA).

This means that the TGA no longer accepts the above-mentioned ISO 13485 certificate as manufacturer evidence required to support applications for IVD products to be included in the ARTG (Australian Register of Therapeutic Goods).

Currently, the TGA accepts the following manufacturer certificates:

1. A certificate issued by a notified body designated by the medical device regulatory agency of an EU member state in accordance with the EU medical device regulatory framework;

2. Decision of the U.S. Food and Drug Administration (FDA);

3. Approvals and licenses issued by Health Canada;

4. Japanese pre-market approval (issued by the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) or the Registration Certification Body (RCB), as applicable);

5. Registered with the Singapore Health Sciences Authority (HSA);

6. Certificates and reports issued under the Medical Device Single Audit Program (MDSAP). (Recognized by the five countries of MDSAP, highly recommended!)

The original text is as follows:

What is MDSAP certification?

The full name of MDSAP is "Medical Device Single Audit Program". It is a medical device quality management system certification program jointly developed by five countries (the United States, Canada, Australia, Japan and Brazil).

MDSAP aims to provide a single audit program for medical device manufacturers worldwide to comply with the regulatory requirements of five countries and regions at the same time. Enterprises participating in MDSAP certification will be recognized by five countries and regions through one audit, which saves time and cost, and reduces the risk of multiple audits in multiple countries and regions.

MDSAP certification is very beneficial for medical device manufacturers who want to sell their products to participating countries and regions. It can help companies meet the regulatory requirements of different countries and regions and improve the competitiveness of products in the global market.

The TGA will soon publish guidance on new manufacturer certification for IVD medical devices. The Guorui Zhongan team will notify you as soon as the file comes out.