Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For subsection 41HB(3) of the Act, the conditions mentioned in this regulation apply to an approval granted to a person to use a kind of medical device solely for experimental purposes in humans.
(2) Before the commencement of any clinical trial proposed to be undertaken in relation to the device, the person to whom the approval is granted and the principal investigator of the clinical trial must give to the Secretary:
(a) a written assurance that each clinical trial will be conducted in accordance with 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; and
(b) a written undertaking:
(i) that the person will comply with any request by an authorised person, whether made before or after the commencement of a clinical trial, to give to the authorised person information about the conduct of the trial; and
(ii) that the person will allow an authorised person to do any of the things mentioned in regulation 7.4 in relation to a clinical trial.