Singapore legislation
Regulation 3C
Regulation 3C
Manufacture of Class A medical devices for charitable purposes
Subregulation 1
A person may manufacture a Class A medical device without holding a manufacturer’s licence under section 12(1) of the Act if the following requirements are satisfied:
the Class A medical device is intended for the use of a citizen or permanent resident of Singapore who is unable to bear the cost of the medical device due to impecuniosity (called in this regulation the recipient);
the person manufactures the Class A medical device at the request or instruction of the recipient, or another person that intends to supply the medical device to the recipient;
the person obtains the prior approval of the Authority before manufacturing the Class A medical device;
the person —
does not solicit or receive any remuneration from any person for the manufacture of the Class A medical device; or
receives any payment only as reimbursement for any costs and expenses the person reasonably incurred under a contract or an arrangement with another person for the manufacture of the Class A medical device.
Subregulation 2
A person mentioned in paragraph (1) is subject to the duties and obligations of a manufacturer of a medical device under regulations 33(a), 38, 39, 41, 42, 44, 45, 46 and 47.
Subregulation 3
For the purposes of paragraph (1), a medical device is treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered.
Subregulation 4
In paragraph (1)(d)(i), “remuneration” includes any payment, commission, incentive, benefit or reward, in money or money’s worth.