Singapore legislation
Regulation 4
Regulation 4
Manufacture of medical devices by way of secondary assembly
Subregulation 1
A person may manufacture a medical device without holding a manufacturer’s licence under section 12(1) of the Act if the following requirements are satisfied:
the medical device is manufactured by way of secondary assembly;
the person —
holds an importer’s licence under section 13(1) of the Act or a wholesaler’s licence under section 14(1) of the Act; and
is able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485.
Subregulation 2
A person mentioned in paragraph (1) is subject to the duties and obligations of a manufacturer of a medical device under regulations 33(a), 38, 39, 41, 42, 44, 45, 46 and 47.
Subregulation 3
A person that is —
[Deleted by S 809/2023 wef 18/12/2023](aa)a healthcare service licensee; or
a retail pharmacy licensed under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016),may manufacture a medical device without holding a manufacturer’s licence under section 12(1) of the Act, if the medical device is manufactured by way of secondary assembly solely for the purpose of supplying the medical device in packaging that is smaller in size than the original packaging of the medical device, or in a quantity smaller than the quantity in which the medical device is supplied to that person.
Subregulation 4
A person mentioned in paragraph (3) must ensure that the secondary packaging of the medical device bears the following information:
the expiry date or shelf life of the medical device that is consistent with the information on the label on the primary packaging of the medical device as approved by the Authority;
such other requirements as the Authority may require.
Subregulation 5
A person mentioned in paragraph (1) or (3) must ensure that the information on any label of the secondary packaging of the medical device is consistent with the information on the label of the primary packaging of the medical device as approved by the Authority.
Subregulation 6
In this regulation —
Definition
“original packaging”, in relation to a medical device, means the outer packaging for the medical device used when the medical device is supplied to a person mentioned in paragraph (1) or (3);
Definition
“primary packaging”, in relation to a medical device, means packaging that maintains the sterility or integrity of the medical device;
Definition
“secondary assembly” means the process of repackaging a medical device from its original packaging into secondary packaging, without any breach of the primary packaging, before the medical device is supplied;
Definition
“secondary packaging”, in relation to a medical device, means the outer packaging for the medical device used in substitution for the original packaging.