Regulation 2B

the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage 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

the medical device —

is an unregistered medical device that is imported for the purpose of the supply of that medical device by the applicant in accordance with regulation 7 or 10;

is an unregistered medical device that is imported for the purpose of the supply of the medical device by, or procured by, any of the following persons in accordance with regulation 8:

a qualified practitioner;

[Deleted by S 809/2023 wef 18/12/2023](C)a healthcare service licensee;

is an unregistered medical device that is imported for the purpose of the supply of the medical device on behalf of, or procured on behalf of, any of the following persons in accordance with regulation 8:

a qualified practitioner;

[Deleted by S 809/2023 wef 18/12/2023](C)a healthcare service licensee;

is an unregistered medical device that is imported solely for the purpose of re‑export in accordance with regulation 9;

is intended to be supplied for use on a ship, and the medical device is one that is required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. S 181/2014) or any other written law, for the treatment of persons on board the ship;

is intended to be supplied for use on an aircraft, and the medical device forms part of the medical supplies required under the Air Navigation Order (O 2) or any other written law for the treatment of persons on board the aircraft;

is a registered medical device that is authorised for import by the registrant of the medical device; or

is in all respects the same as a registered medical device, the registrant of which has not authorised the applicant to import the registered medical device.

an applicant who intends to import a medical device under paragraph (1)(b)(iii) or (vii) must be able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and

an applicant who intends to import a medical device under paragraph (1)(b)(viii) —

must be able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and

must obtain the Authority’s prior approval for each consignment of the medical device to be imported.