Singapore legislation
Regulation 31
Regulation 31
Duty of licensees, suppliers and registrants to comply with enforcement orders
Subregulation 1
A licensee, supplier or registrant of a medical device shall, if required by the Authority or an enforcement officer —
produce his licence or certificate of registration, or such other document as the Authority or enforcement officer may specify for ensuring compliance with the Act, to the Authority or enforcement officer for inspection;
furnish the Authority or enforcement officer with such information as the Authority or enforcement officer may require for ensuring compliance with the Act; and
attend at such place as the Authority or enforcement officer may specify to produce that licence, certificate or other document or furnish that information.
Subregulation 2
An enforcement officer may conduct routine inspections of —
any premises that are being used for the manufacture, supply or storage of medical devices; and (b)any conveyances that are being used for the transport of medical devices.
Subregulation 3
An enforcement officer conducting an inspection under paragraph (2) may —
require the person having possession or control of any medical device that is found during the inspection —
to furnish, without charge, a sample of the medical device for the Authority’s examination; or
to send, at the person’s own cost, a sample of the medical device to a testing laboratory approved by the Authority to carry out such tests as the Authority may require within the time specified by the Authority or, if no time is specified, within a reasonable time; and
take or cause to be taken any photograph of —
the premises or conveyance mentioned in paragraph (2); or
any property or material found on the premises or conveyance.
Subregulation 3A
Where a person having possession or control of a medical device is required to send a sample of the medical device for testing under paragraph (3)(a)(ii), the person must furnish a copy of the results of the test to the Authority within such time as the Authority may specify.
Subregulation 4
A licensee, supplier or registrant of a medical device whose premises are being used for the manufacture, supply or storage of medical devices, or whose conveyances are being used for the transport of medical devices, shall allow an enforcement officer —
to conduct routine inspections of those premises or conveyances; and
to take, without payment, for testing, examination or analysis a sample of any medical device that is found pursuant to the inspection.
Subregulation 5
Any person who contravenes paragraph (1) 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.