Registering your product
MDA REGISTRATION CONSULTANT
Only companies registered locally in Malaysia with the Companies Commission (SSM) may apply to obtain an establishment license, register a medical device. Only companies which have an Establishment License can register a medical device in Malaysia.
KKM has required establishment to apply for a licence under the Act before it can import, export or place in the market any registered medical device. For that purpose, an application for an establishment licence shall be made according to the requirements. Seller should obtain mentioned certification and audited by Conformity Assessment Body (CAB) in order to receive approval for their application. We are able to assist our clients to comply and advising the compliance and official submission to MDA.
The Malaysian Medical Device Authority (MDA) requires international manufacturers to appoint a Local Authorized Representative. The LAR is also known as a marketing permission holder or in-country representative.
Since 2016, VOLT MEDITECH has served as a Local Authorized Representative in Malaysia. We have developed our quality management system certification, namely the Good Distribution Practice for Medical Devices (GDPMD) certification.
Medical device makers and distributors may appoint us to represent them in Malaysia in any cases brought up by the Malaysian Medical Devices Authority (MDA), the country's legislative authority for medical devices. We shall have the authority to act on your behalf in relation to your duties under the Malaysian medical device regulatory system as your authorised representative.
As your neighbourhood authorized representative in Malaysia we will:-
Represent your company in all dealings with the Medical Device Authority and other institutions responsible for medical devices and in-vitro diagnostics including:
Submitting changes notifications
Authorize your selected Importers and/or Distributors to import and sell your device in Malaysia
Ensure that the medical device or IVD is correctly labelled and that information is provided in either English or together with Bahasa Malay for home use devices
Maintain our office including a telephone and email connection in Malaysia
Monitor regulations to alert you to any changes or new regulations applicable to your product