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.
Division 2 — Unregistered medical devices
Exception for custom-made medical devices
6. 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 custom-made medical device that is unregistered.
Exception for refurbished medical devices
7. 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 return, after refurbishment of a medical device, of the unregistered refurbished medical device to the private hospital, medical clinic, clinical laboratory or healthcare establishment licensed under the Private Hospitals and Medical Clinics Act (Cap. 248) which owns the medical device.
Exception for medical devices for patients’ use
8. 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
(b)
a private hospital, medical clinic or clinical laboratory licensed under the Private Hospitals and Medical Clinics Act (Cap. 248) for the use of a patient of that private hospital, medical clinic or clinical laboratory,
if the Authority has granted an importer’s licence or a wholesaler’s licence in respect of the medical device for such use.
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 Authority has granted an importer’s licence or a wholesaler’s licence in respect of the medical device for such purpose.
(2) In paragraph (1), “non-clinical purpose” means any purpose other than a purpose described in the second column of item 1 of the First Schedule to the Act.
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 (Cap. 176) before 10th August 2010; and
(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 of an unregistered Class A or B medical device —
(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 (Cap. 176) before 10th August 2010;
(iv)
which complies with the First Schedule;
(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 September 2011, and does not at any time reject, an application for registration as a Class A or B medical device;
(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 5 or 6 of the Radiation Protection Act (Cap. 262) and has not expired;
(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;
(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; and
(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.
(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.
Division 3 — Requirements for supply
Testing of registered medical devices before supply
12.—(1) For the purposes of section 17(1) of the Act, the supply of any registered medical device taken from a lot or consignment of such registered medical devices shall be carried out only after the following requirements are complied with:
(a)
2 samples (or more if required by the Authority) of the registered medical devices taken from that lot or consignment at each periodic taking of samples therefrom have been tested or analysed in accordance with the requirements specified by the Authority for registering that medical device;
(b)
the results and protocol of any test or analysis have been provided to the Authority; and
(c)
the Authority is satisfied from the results and protocol that a registered medical device from that lot or consignment meets or continues to meet the requisite standards of quality, safety and efficacy.
(2) For the purposes of paragraph (1)(c), a registered medical device found in the same lot or consignment from which the samples are taken under paragraph (1)(a) shall be presumed to possess the same properties as the samples.
Supply of “professional use only” medical devices
13. For the purposes of section 17(1) of the Act —
(a)
no licensed wholesaler of medical devices shall supply any registered “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
(b)
no person shall supply, by way of administration or application to any other person, any registered “professional use only” medical device, unless the person administering or applying the medical device is, or acts under the supervision of, a qualified practitioner.
