The declaration of conformity
Australian medical devices guidelines
Guidance document number 5, Version 1.6
This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.
As part of the conformity assessment procedures, the manufacturer of a medical device will be required to make a declaration of conformity which, in most cases, declares that the medical device complies with:
- the applicable provisions of the essential principles;
- the classification rules; and
- the conformity assessment procedures;
before being supplied in Australia.
Australian medical devices guidelines: 5. The declaration of conformity (pdf,145kb)