(1)

For subsection 41HB (7) of the Act, the conditions mentioned in this regulation apply to the use by a person, for experimental purposes in humans, of a kind of medical device that is the subject of an approval granted to someone else under paragraph 41HB (1) (e) of the Act.

(2)

The use of the device must comply with a procedural protocol approved by the ethics committee that is to be responsible for monitoring the conduct of the trial at each trial site (the responsible ethics committee ).

(3)

The use of the device must be in accordance with the ethical standards set out in the `National Statement on Ethical Conduct in Research Involving Humans', published by the National Health and Medical Research Council, as in force from time to time.

(4) The person must cease using the device if the responsible ethics committee informs the principal investigator of the clinical trial that the use is inconsistent with:

(a)

the protocol mentioned in subregulation (2); or

(b)

any condition subject to which approval for the use was given.