PART III | SUPPLY OF MEDICAL DEVICES |
| Division 1 — Wholesale supply |
| Requirements for issue of wholesaler’s licence |
4D.—(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 —| (a) | 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 | | (b) | 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. |
(2) Paragraph (1)(b) does not apply if the applicant —| (a) | 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; | | (b) | supplies by wholesale an unregistered medical device that is manufactured solely for export, or imported solely for re‑export, in accordance with regulation 9; | | (c) | supplies by wholesale an unregistered medical device that is imported or supplied for a non‑clinical purpose in accordance with regulation 10; | | (d) | 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 | | (e) | 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). [S 318/2018 wef 01/06/2018] |
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| Wholesaling of self-manufactured medical devices |
| 5. A licensed manufacturer who manufactures a medical device may supply that medical device by wholesale without holding a wholesaler’s licence under section 14(1) of the Act. |
| Wholesaling of medical device licensed under Radiation Protection Act |
5A. A person may carry out any activity that is a supply by wholesale, without holding a wholesaler’s licence as required under section 14(1) of the Act, in relation to any medical device —| (a) | in respect of which a licence is granted under the Radiation Protection Act 2007 for that activity; and [S 434/2023 wef 31/12/2021] | | (b) | which is registered under the Act. [S 318/2018 wef 01/06/2018] [S 334/2016 wef 01/11/2016] |
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| Wholesaling of medical device for use in clinical research |
5B.—(1) A person may supply by wholesale, without holding a wholesaler’s licence as required under section 14(1) of the Act, any medical device if —| (a) | the planned use for the medical device is a clinical purpose in any clinical research; and | | (b) | subject to paragraph (2), where the person is the manufacturer of the medical device, the person gives the Authority notice in accordance with regulation 51 of the supply by wholesale before so supplying the medical device. [S 318/2018 wef 01/06/2018] [S 318/2018 wef 01/06/2018] |
| (2) Paragraph (1)(b) does not apply if the person manufactures the medical device solely by way of secondary assembly. [S 318/2018 wef 01/06/2018] |
| (3) In paragraph (2), “secondary assembly” has the same meaning as in regulation 4(6). [S 318/2018 wef 01/06/2018] |
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| Division 2 — Unregistered medical devices |
| Exception for custom-made medical devices, etc. |
6. Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of —| (a) | a medical device that is manufactured in accordance with regulation 3; | | (b) | a laboratory‑developed test that is an unregistered medical device and is manufactured in accordance with regulation 3B; or | | (c) | a custom‑made medical device that is an unregistered medical device. [S 318/2018 wef 01/06/2018] |
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| Exception for medical devices which underwent maintenance or repair |
| 7. Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the return, after undergoing maintenance or repair, of an unregistered medical device to the person who owns that medical device. [S 318/2018 wef 01/06/2018] |
| Exception for medical devices for patients’ use |
8.—(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) | a qualified practitioner for the use of a patient of that qualified practitioner; or [S 1080/2021 wef 03/01/2022] [S 809/2023 wef 18/12/2023] | | (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. |
[S 318/2018 wef 01/06/2018] [S 434/2023 wef 26/06/2023] (2) Where a person mentioned in paragraph (1) supplies, or procures the supply of, an unregistered medical device, the person —| (a) | must —| (i) | hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or | | (ii) | 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 |
| | (b) | must not supply that unregistered medical device to another person except with the Authority’s prior approval. [S 318/2018 wef 01/06/2018] |
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(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 —| (a) | must —| (i) | hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or | | (ii) | be able to comply with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and |
| | (b) | must not supply that unregistered medical device to another person except with the Authority’s prior approval. [S 318/2018 wef 01/06/2018] |
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| Exception for export or re-export |
| 9. 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 a medical device that is manufactured solely for export or that is imported solely for re-export, if the Authority has granted an importer’s licence or a wholesaler’s licence in respect of the medical device for the purpose of export or re-export only. |
| Exception for non-clinical use |
| 10.—(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 a medical device that is imported, supplied or used for a non-clinical purpose, if the requirements in paragraph (1A) are satisfied. [S 318/2018 wef 01/06/2018] (1A) The requirements mentioned in paragraph (1) are that the person who supplies the unregistered medical device —| (a) | must —| (i) | hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or | | (ii) | 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 |
| | (b) | must not supply that medical device to another person except with the Authority’s prior approval. [S 318/2018 wef 01/06/2018] |
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| (2) In paragraph (1), “non-clinical purpose” means any purpose other than a purpose described in paragraph (a) of the definition of “Medical device” in the second column of item 1 of the First Schedule to the Act. [S 318/2018 wef 01/06/2018] |
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| Exception for clinical research |
10A.—(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 by a person does not apply to the supply of a medical device if —| (a) | the planned use for the medical device is a clinical purpose in any clinical research; and | | (b) | subject to paragraph (2), where the person is the manufacturer of the medical device, the person gives the Authority notice of the supply in accordance with regulation 51 before supplying the medical device. [S 318/2018 wef 01/06/2018] [S 318/2018 wef 01/06/2018] |
| (2) Paragraph (1)(b) does not apply if the person manufactures the medical device solely by way of secondary assembly. [S 318/2018 wef 01/06/2018] |
| (3) In paragraph (2), “secondary assembly” has the same meaning as in regulation 4(6). [S 318/2018 wef 01/06/2018] |
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| Exception for Class A medical devices |
10B.—(1) Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of a Class A medical device that is —| (a) | manufactured under a valid manufacturer’s licence or in accordance with regulation 3C; | | (b) | imported by the supplier under a valid importer’s licence; or | | (c) | obtained by the supplier from a wholesaler who holds a valid wholesaler’s licence. [S 318/2018 wef 01/06/2018] |
| (2) For the purposes of paragraph (1), a medical device shall be treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered. [S 169/2012 wef 01/05/2012] [S 318/2018 wef 01/06/2018] |
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| Exceptions for phased implementation of prohibition |
11.—(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 —| (a) | the supply no later than 31st December 2011 of an unregistered Class A or B medical device —| (i) | which is not an implantable medical device; | | (ii) | which is not, or cannot be, licensed as a medicinal product under the Medicines Act 1975 before 10th August 2010; and [S 434/2023 wef 31/12/2021] | | (iii) | in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act; |
| | (b) | the supply on or after 1st January 2012, but before 1st June 2018, of an unregistered Class A or B medical device (but not an unregistered Class A medical device supplied on or after 1st May 2012 in accordance with the requirements specified in regulation 10B) —| (i) | which is listed on the Class A or B Medical Device Transition List as published on the Authority’s website on or before 1st January 2012; | | (ii) | which qualifies for evaluation under an abridged evaluation process referred to in regulation 26; | | (iii) | which is not, or cannot be, licensed as a medicinal product under the Medicines Act 1975 before 10th August 2010; [S 434/2023 wef 31/12/2021] | | (iv) | which complies with the First Schedule as in force immediately before 1 June 2018; [S 318/2018 wef 01/06/2018] | | (v) | in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act; and | | (vi) | in respect of which the Authority receives, before 1st December 2011, and does not at any time reject, an application for registration as a Class A or B medical device; [S 140/2012 wef 05/04/2012] [S 169/2012 wef 01/05/2012] [S 318/2018 wef 01/06/2018] |
| | (c) | the supply no later than 31st July 2011 of an unregistered Class C or D medical device —| (i) | which is not an implantable medical device; and | | (ii) | in respect of which a licence to deal with the medical device has been granted under section 6 or 7 of the Radiation Protection Act 2007 and has not expired; [S 434/2023 wef 31/12/2021] |
| | (d) | the supply at any time of an unregistered Class C or D medical device —| (i) | which is listed on the Class C or D Medical Device Transition List as published on the Authority’s website on or before 10th August 2010; | | (ii) | which qualifies for evaluation under an abridged evaluation process referred to in regulation 26; | | (iii) | which, if it is an implantable medical device, has been approved, before 1st January 2011, by at least 2 competent regulatory agencies referred to in regulation 26; | | (iv) | which complies with the First Schedule as in force immediately before 1 June 2018; [S 318/2018 wef 01/06/2018] | | (v) | in respect of which the Authority does not at any time receive any information concerning, and does not at any time become aware of, any defect or adverse effect under section 42(2) of the Act; and | | (vi) | in respect of which the Authority receives, and does not at any time reject, an application for registration as a Class C or D medical device; [S 140/2012 wef 05/04/2012] |
| | (e) | the retail supply, at any time, by a retail supplier of an unregistered medical device that the retail supplier has taken possession of before 10th August 2010; [S 140/2012 wef 05/04/2012] [S 426/2012 wef 01/09/2012] | | (f) | the retail supply, at any time, by a retail supplier of an unregistered Class A or B medical device that the retail supplier has taken possession of on or after 10th August 2010 but before 5th April 2012; [S 140/2012 wef 05/04/2012] [S 426/2012 wef 01/09/2012] | | (g) | the supply on or after 1st September 2012, but before 1st June 2018, of an unregistered Class A or B medical device, not being an unregistered Class A medical device supplied in accordance with the requirements in regulation 10B, which is listed on the Class A or B Medical Device Transition List as published on the Authority’s website; and [S 426/2012 wef 01/09/2012] [S 318/2018 wef 01/06/2018] | | (h) | the supply on or after 1st September 2012, but before 1st June 2018, of an unregistered Class C or D medical device which is listed on the Class C or D Medical Device Transition List as published on the Authority’s website. [S 426/2012 wef 01/09/2012] [S 318/2018 wef 01/06/2018] |
| (2) For the purposes of paragraph (1), a medical device shall be treated as assigned to a particular class of medical devices, if it would have been assigned to that class according to regulation 24 had the medical device been registered. |
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| Division 2A — Other exceptions |
| Exception for import of medical device by licensed manufacturer without importer’s licence |
| 11A. The holder of a manufacturer’s licence may import a medical device without holding an importer’s licence, if the medical device is required for the purpose of carrying out the manufacture of another medical device in accordance with the conditions of the manufacturer’s licence. [S 318/2018 wef 01/06/2018] |
| Exception for wholesale of medical devices to ships or aircraft by licensed importer without wholesaler’s licence |
11B.—(1) A person may supply by wholesale an unregistered medical device to a ship without holding a wholesaler’s licence, if —| (a) | the medical device is imported in accordance with the requirements in regulation 2B(1)(b)(v); and | | (b) | the person holds an importer’s licence for the medical device. |
(2) A person may supply by wholesale an unregistered medical device to an aircraft without holding a wholesaler’s licence, if —| (a) | the medical device is imported in accordance with the requirements in regulation 2B(1)(b)(vi); and | | (b) | the person holds an importer’s licence for the medical device. |
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(3) Despite any other provision in these Regulations, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of an unregistered medical device —| (a) | for use on a ship in accordance with paragraph (1); or | | (b) | for use on an aircraft in accordance with paragraph (2). [S 318/2018 wef 01/06/2018] |
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| Previously registered medical devices |
11C. A supplier of a registered medical device may continue to supply the medical device, by administration to a person or by retail sale, despite the cancellation of the registration of the medical device and despite the prohibition in section 15(1) of the Act against the supply of a health product that is not registered, if —| (a) | the cancellation of the registration is either made by the Authority under section 37(2) of the Act or upon the application of the registrant under section 37(3) of the Act; | | (b) | the supplier has taken possession of the medical device before the cancellation of its registration; and | | (c) | the Authority does not direct a recall of the medical device from the market. [S 318/2018 wef 01/06/2018] |
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| Division 3 — Requirements for supply |
| Supply of Class A medical devices |
12.—(1) For the purposes of section 17(1) of the Act and without prejudice to regulation 35A, a person who supplies a Class A medical device in accordance with regulation 10B must furnish such information about the medical device as the Authority may require.| (2) The person mentioned in paragraph (1) must furnish the information within such time and in such manner as the Authority may specify. |
| (3) For the purposes of paragraph (1), a medical device is treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered. [S 318/2018 wef 01/06/2018] |
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| Supply of “professional use only” medical devices |
13.—(1) For the purposes of section 17(1) of the Act —| (a) | no licensed wholesaler of medical devices shall supply any “professional use only” medical device to any person who intends to supply that medical device to others unless that person is —| (i) | also a licensed wholesaler of medical devices; or | | (ii) | a qualified practitioner; and [S 318/2018 wef 01/06/2018] |
| | (b) | no person shall supply, by way of administration or application to any other person, any “professional use only” medical device, unless the person administering or applying the medical device is, or acts under the supervision of, a qualified practitioner. [S 318/2018 wef 01/06/2018] [S 318/2018 wef 01/06/2018] |
(2) In paragraph (1), “ “professional use only” medical device” means —| (a) | a registered “professional use only” medical device; or | | (b) | an unregistered “professional use only” medical device supplied in accordance with regulation 8. [S 318/2018 wef 01/06/2018] |
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| Supply of medical devices for use in clinical research |
13A.—(1) A person who manufactures a medical device under regulation 3A, imports a medical device under regulation 4C, or is supplied with a medical device under regulation 5B or 10A, may only supply the medical device —| (a) | as one whose planned use is a clinical purpose in any clinical research; or | | (b) | as a medical device for some other purpose that the Authority has allowed and no other. |
| (2) To avoid doubt, as from the time that the Authority has allowed the supply mentioned in paragraph (1)(b), the medical device ceases to be a medical device whose planned use is a clinical purpose in any clinical research for the purposes of these Regulations; but continues to be subject to any applicable law relating to medical devices (including these Regulations). |
| (3) Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both. [S 334/2016 wef 01/11/2016] |
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| Supply of “trained user only” medical devices |
13B.—(1) For the purposes of section 17(1) of the Act, a person must not supply a “trained user only” medical device to another person (P) unless the person, at or before the time the medical device is supplied to P —| (a) | provides, or ensures the provision of, such training on the safe and efficacious use of the medical device as the manufacturer of the medical device determines is necessary, to every user of the medical device; or | | (b) | ensures that every user of the medical device has received the training mentioned in sub‑paragraph (a). |
(2) In paragraph (1) —““trained user only” medical device” means —| (a) | a registered “trained user only” medical device; or | | (b) | an unregistered “trained user only” medical device supplied in accordance with regulation 8 or 10; |
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| “user”, in relation to a medical device, means an individual who is an employee or contractor of, or otherwise associated with, P. [S 318/2018 wef 01/06/2018] |
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