Singapore legislation
Regulation 8
Regulation 8
Exception for medical devices for patients’ use
Subregulation 1
Without prejudice to any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product shall not apply to the supply of an unregistered medical device by or on behalf of, or procured by or on behalf of —
a qualified practitioner for the use of a patient of that qualified practitioner; or (b)[Deleted by S 809/2023 wef 18/12/2023](c)a healthcare service licensee for the use of a patient of that healthcare service licensee,if paragraph (2) or (3) is satisfied.
Subregulation 2
Where a person mentioned in paragraph (1) supplies, or procures the supply of, an unregistered medical device, the person —
must —
hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or
be 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 unregistered 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
must not supply that unregistered medical device to another person except with the Authority’s prior approval.
Subregulation 3
Where a person (P) supplies, or procures the supply of, an unregistered medical device on behalf of a person mentioned in paragraph (1), P —
must —
hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or
be able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and
must not supply that unregistered medical device to another person except with the Authority’s prior approval.