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?
- Only a company with a valid Distributor’s License may distribute medical devices in Malaysia. This company may also hold an Importer’s License to also act as an importer for your medical device.
- Starting June 2021, the Malaysian Medical Device Authority (MDA) allows multiple authorized representatives for medical devices. This was announced on 14 September 2021, repealing Circular Letter No. 1/2014 for Establishments Carrying Out the Role as an Authorized Representative (AR) and took effect on 17 June 2021 in accordance with the decision made in MDA Meeting No. 2/2021. This means that as of 17 June 2021 the MDA no longer limits medical device registrations to a single authorized representative and so allows the registration of a single medical device by multiple authorized representatives. The MDA also no longer limits the importation and placing of medical devices on the Malaysian market to one authorized representative
- However, if you choose to appoint an independent Local Authorized Representative (LAR) as the registrant of your medical device you can then work with as many importers and distributors for your product as you wish. Choosing to work with an LAR rather than directly with an importer or distributor gives you real flexibility in your distribution strategy. This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
What are the requirements for distributing medical devices in Malaysia?
- Only local Malaysian companies can apply for a Distributor’s License. The company must have a Medcast account from the Medical Device Authority (MDA) in order to apply for this license.
- A Letter of Authorization for Distributor (in the prescribed format) needs to be provided by the LAR for all products and models of the devices which are to be distributed. The Letter of Authorization must be issued on the LAR’s Letterhead.
- The distributor’s company must also hold valid Good Distribution Practice for Medical Devices (GDPMD) certification that specifies the storage and/or distribution of the categories of medical devices concerned and the activities performed at the facility.
Advertising rules
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:
- maintain their GDPMD certification and a valid Distributor’s Licence
- maintain distribution records
- maintain records of any complaints
- report any Adverse Events (AE) or Field Corrective Actions (FCA) to the Medical Device Authority.
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:
- authorize your selected distributor(s) to sell your device in Malaysia
- liaise with your licensed distributor(s) concerning the post-market surveillance of your registered product including the mandatory reporting of Adverse Events and Field Corrective Actions
- and of course, carry out our full range of registration, LAR and post-market surveillance services.
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market.