Singapore legislation
Regulation 4D
Regulation 4D
Requirements for issue of wholesaler’s licence
Subregulation 1
For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of a wholesaler’s licence for a medical device are that —
the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the medical device as are necessary to prevent the deterioration of the medical device while it is in the applicant’s ownership, possession or control; and
subject to paragraph (2), the applicant is able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485.
Subregulation 2
Paragraph (1)(b) does not apply if the applicant —
returns an unregistered medical device which has undergone maintenance or repair to the person who owns the unregistered medical device in accordance with regulation 7;
supplies by wholesale an unregistered medical device that is manufactured solely for export, or imported solely for re‑export, in accordance with regulation 9;
supplies by wholesale an unregistered medical device that is imported or supplied for a non‑clinical purpose in accordance with regulation 10;
supplies by wholesale a medical device to a ship, if the medical device is an unregistered medical device and is imported in accordance with the requirements in regulation 2B(1)(b)(v); or
supplies by wholesale a medical device to an aircraft, if the medical device is an unregistered medical device and is imported in accordance with the requirements in regulation 2B(1)(b)(vi).