36A. Duties of sponsor, etc.

This regulation applies in relation to any medical device manufactured under regulation 3A, imported under regulation 4C or supplied under regulation 5B or 10A.

Without prejudice to regulation 13A, a person must not use the medical device, and the sponsor must ensure that no person involved in the clinical research uses the medical device except —

for a clinical purpose in the research, and where the research requires approval of an institutional review board, with the approval of that board; or

for some other use that the Authority has allowed and no other.

To avoid doubt, as from the time that the Authority has allowed the other use mentioned in paragraph (2)(b), the medical device ceases to be a medical device whose planned use is, or which must be used, for a clinical purpose in any clinical research for the purposes of these Regulations; but continues to be subject to any applicable law relating to medical devices (including these Regulations).

Unless the Authority otherwise allows, the sponsor must ensure that, within 6 months after the conclusion or termination of the clinical research, any unused medical device for that research is disposed of or exported.

Any person who contravenes paragraph (2) or (4) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

In this regulation, “unused medical device” means any medical device referred to in paragraph (1) that —

is not used in the clinical research (including where the medical device cannot or can no longer be used in the research); or

is reusable after the conclusion or termination of the clinical research.

This regulation applies in relation to any medical device manufactured under regulation 3A, imported under regulation 4C or supplied under regulation 5B or 10A.

Without prejudice to regulation 13A, a person must not use the medical device, and the sponsor must ensure that no person involved in the clinical research uses the medical device except —

for a clinical purpose in the research, and where the research requires approval of an institutional review board, with the approval of that board; or

for some other use that the Authority has allowed and no other.

To avoid doubt, as from the time that the Authority has allowed the other use mentioned in paragraph (2)(b), the medical device ceases to be a medical device whose planned use is, or which must be used, for a clinical purpose in any clinical research for the purposes of these Regulations; but continues to be subject to any applicable law relating to medical devices (including these Regulations).

Unless the Authority otherwise allows, the sponsor must ensure that, within 6 months after the conclusion or termination of the clinical research, any unused medical device for that research is disposed of or exported.

Any person who contravenes paragraph (2) or (4) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

In this regulation, “unused medical device” means any medical device referred to in paragraph (1) that —

is not used in the clinical research (including where the medical device cannot or can no longer be used in the research); or

is reusable after the conclusion or termination of the clinical research.