December 17, 2019
Recently, on 15th November 2019, the Malaysian Government passed the order to gazette Medical Device (Advertising) Regulations 2019 (‘Advertising Regulations’), based on the Medical Devices Act 2012.
This subsidiary legislation will come into operation on 1 July 2020.
According to the Medical Device (Advertising) Regulations 2019 (‘Advertising Regulations’), advertising any registered medical device without the approval from Medical Device Authority (MDA) is a punishable offence. Contravening the sub regulations would result in heavy penalties, as stipulated in writing. Even though a medical device has been registered with the MDA, any form of advertisement, be it in hardcopy or in softcopy, must be submitted for approval with the Authority, to ensure the content is appropriate.
An application for an approval to advertise a registered medical device shall be made to MDA in writing and shall be accompanied by the following:
(a) a copy of the proposed advertisement for the registered medical device;
(b) a processing fee of one thousand ringgit
(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
During this application for approval, the Authority may request the applicant to furnish any other particulars, information or documents.
It is to be noted that any form of 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
The second regulation to take note of is the Medical Device (Duties and Obligations of Establishments) Regulations 2019 (‘Establishments Regulations’).
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