Medical device advertising regulations in Malaysia
The Malaysian Medical Device Authority has issued an announcement reminding medical device manufacturers, distributors and the public that the Medical Device (Advertising) Regulations 2019 were implemented on 4 May 2021. With full enforcement of the regulations commencing on 1 January 2022.
In the meantime, manufacturers, distributors, advertising agencies and other parties concerned may apply for advertising approval from the MDA. Applications for approval must be made in line with the procedures outlined in recently issued guidance documents.
The MDA has issued 2 guidance documents regarding the code and rules that must be observed when advertising registered medical devices in Malaysia as well as the procedure for obtaining the authority’s approval:
- MDA/GD/0032: Code of Advertisement (COA)
- MDA/GL/04: Guideline Application for Medical Device Advertisement Approval – Requirements.
The MDA is also preparing a series of training sessions related to the Medical Device (Advertising) Regulations. Please refer to the MDA website for details.
If you have any queries regarding advertising medical devices or our services for medical device registration and representation in Malaysia, please contact us at [email protected]