Medical device distribution in Malaysia
Only registered medical devices may be distributed in Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR), unless exempted from registration.
Who can distribute medical devices in Malaysia?
What are the requirements for distributing medical devices in Malaysia?
Advertising, communication and promotion of medical device is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. Please note that Malaysia is currently in a transitional period until 31st December 2021 for the implementation of Medical Device (Advertising) Regulation 2019 while the MDA specifies details for its implementation.
According to the Medical Device (Advertising) Regulation 2019, no person shall advertise any registered medical device without the approval from the Authority. Any person who commits an offence, shall, upon 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.
The Medical Device (Advertising) Regulation 2019 states that applications for approval for an advertisement shall be submitted in writing to the MDA along with a copy of the proposed advertisement, the processing fee of one thousand ringgit (approx. 235 US Dollars) and a letter of appointment from the establishment whose medical device is being advertised if applicable. Each advertisement must include the registration number assigned by the MDA to the said medical device.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs to Malaysia to:
How Andaman Medical can help with distributing medical devices in Malaysia:
Acting as your independent local authorized representative or marketing authorization holder in Malaysia, we will register and maintain your device license which also means you can appoint as many distributors for your device as you require while the product license is not affected by any changes in your distributor network. We will work with your chosen distributor(s) to: