IN exercise of the powers conferred by paragraph 79(2)(h) of the Medical Device Act 2012 [Act 737], the Minister makes the following regulations:
Regulation 1 · Citation and commencement
1. (1) These regulations may be cited as the Medical Device (Advertising) Regulations 2019. (2) These Regulations come into operation on 1 July 2020.
Regulation 2 · Conditions for advertising
2. (1) No person shall advertise any registered medical device without the approval from the Authority. (2) Any person who contravenes subregulation (1) commit an offence and shall, on conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years or to both. (3) An application for an approval to advertise a registered medical device shall be made to the Authority in writing and shall be accompanied by— (a) a copy of the proposed advertisement for the registered medical device; (b) a processing fee of one thousand ringgit; and (c) a letter of appointment from an establishment on whose application the medical device is registered to, if the applicant is appointed by the establishment to advertise the medical device. (4) The Authority may, in writing, at any time after the receipt of an application under subregulation (3), request the applicant to give to the Authority, within the period specified in the request, any other particulars, information or documents.
Regulation 3 · Contents of advertisement
3. An advertisement to advertise a registered medical device shall contain the following information: (a) a certificate that the medical device is registered under the Act; and (b) the registration number assigned to the registered medical device by the Authority.
Made 3 September 2019 [KKM.PUU/PU2/MDA/3(17); PN(PU2)711/IV] DATUK SERI DR. DZULKEFLY BIN AHMAD Minister of Health