Singapore legislation
Regulation 2A
Regulation 2A
Requirements for issue of manufacturer’s licence
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 manufacturer’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 as are necessary for carrying out the manufacture of the medical device to be authorised by the licence;
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;
the applicant is able to conduct all manufacturing operations in such a way as to ensure that the medical device is not wrongly labelled as another type of medical device; and
the applicant is able to comply with the requirements of ISO 13485 in relation to the manufacture of the medical device.