MDSAP (Medical Device Single Audit Program) certification is not explicitly required to register a Class IIa device in Australia. However, having a quality management system in place is essential. For Australia, the Therapeutic Goods Administration (TGA) requires manufacturers to provide evidence of their quality management system, which can include ISO 13485 certification or other regulatory authority certifications, depending on the submission type.
Since your device has US FDA 510(k) clearance and is CE marked, it has already undergone regulatory review in the US and EU. This may help streamline the registration process in Australia, but you will still need to comply with the TGA's specific requirements for device registration.
The TGA accepts a variety of evidence of compliance with the essential principles, including:
- A certificate of conformity issued by a notified body under the European Union's medical device regulations
- A decision by the United States Food and Drug Administration (FDA)
- An approval or license issued by Health Canada
- A pre-market approval from Japan
- A certificate or report issued under the Medical Device Single Audit Program (MDSAP)
- An ISO 13485:2016 certificate issued by a certification body that is also a notified body under the IVDD 98/79/EC
- An ISO 13485:2016 certificate issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA
For more information on TGA requirements, you can refer to their guidance documents available on their website.
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Original Message:
Sent: 15-May-2023 08:15
From: Anonymous Member
Subject: Australia and MDSAP
This message was posted by a user wishing to remain anonymous
Is MDSAP certification required to register a Class IIa device in Australia? The device has US FDA 510(k) clearance and is CE marked.