As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.
In order to make an advertisement an application for an approval to advertise a registered medical device must be submitted to the Ministry of Health Malaysia in writing accompanied by specific documents.
This regulation will come into full effect starting from 1st July 2020.
Anyone found guilty of breaching this regulation shall be liable to a fine not exceeding RM 200,000 or imprisonment for a term not exceeding 2 years or to both.
To facilitate a smooth process for an approval to advertise a registered medical device.
The following documents and steps are required,
- Copy of advertisement plan of the medical device.
- Processing fee of RM 1,000.
- Letter of appointment from the origin of the medical device which it was registered.
Alongside the following 2 pointers to be included in the advertisement.
- A certificate that the medical device is registered under the Act.
- Registration number assigned to the registered medical device by the Authorities.