Health Products (Medical Devices) Regulations 2010

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]

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]

(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]

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]

(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]

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]

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]

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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