Medical Device (Advertising) Regulations in Malaysia

2020-01-13T09:14:09+08:00 December 29th, 2019|Medical Regulation Updates, News & Events|
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According to the Medical Device (Advertising) Regulations 2019, no person shall advertise any registered medical device without prior approval from the relevant Authority. Any application for approval to advertise a registered medical device must be made to the Authority with the specified documents.

On the 3rd of September 2019, the Malaysian Ministry of Health released a regulation regarding the advertisement of medical devices in Malaysia. This regulation will come into full effect from the 1st of July 2020. The Medical Device (Advertising) Regulations 2019 states that no person shall advertise any registered medical device without approval from the Authority. Any person who commits an offence may be liable to a fine of up to two hundred thousand ringgit or imprisonment for a term not exceeding two years or could be subject to both fine and imprisonment.

An application for an approval to advertise a registered medical device shall be made to the Authority in writing with the following documents:

• a copy of the proposed advertisement for the registered medical device
• a processing fee of one thousand ringgit
• a letter of appointment from the establishment to whom the medical device is registered (if the application is appointed)
The following shall be listed on the advertisement:
• a certificate that the medical device is registered under the Act
• the registration number assigned to the registered medical device