Beginning on 26 May 2023, the Therapeutic Goods Administration (TGA) has stopped accepting ISO 13485 certificates as supporting evidence for in vitro diagnostic (IVD) medical device inclusion applications. For any medical devices which still rely on the ISO 13485 certificates during this transition phase were allowed to continue until the expiry date.
The new transition guidance for IVD medical devices evidence will be published soon by TGA. Meanwhile, sponsors are required to include another acceptable manufacturer evidence form as supporting documents for medical device approval.
Since 28 July 2021, the Australian Register of Therapeutic Goods (ARTG) has widened the scope of the conformity assessment documents under Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002. Sponsors can include conformity assessment documents by notified bodies authorized under European Union (EU) but TGA still be responsible for supervising the quality management.
Here are some pieces of evidence documents from overseas regulators that can be included in the TGA inclusion application or conformity assessments:
Certificates authorized by Notified Bodies from EU (MDR, IVDR)
US FDA decisions
Licenses approved by Health Canada
Registration evidence from the Singapore Health Sciences Authority (HSA)
Pre-market approval from the government of Japan (Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) and Registered Certified Body (RCB))
Contact us at info@arqon.com for more information.