25. Requirements for registration

For the purposes of section 30(2)(a)(iii) of the Act, the Authority may, after carrying out an evaluation under section 33 of the Act, register a medical device if the Authority is satisfied —

that the overall intended benefits to an end‑user of the medical device outweigh the overall risks associated with the use of the medical device; and

based on the conformity of the medical device with the safety and performance requirements for the medical device set out on the Authority’s website, that the medical device is suitable for its intended purpose and that any risk associated with its use is minimised.