SERVICES
Authorized Representative
The Malaysia Medical Device Regulations 2012 requires a manufacturer located outside of Malaysia to designate a Local Authorized Representative as a liaison to the Malaysia Authorities.
T T Medical provides qualified and professional Authorized Representative Services in Malaysia and will support your regulatory compliance.
By appointing us as your independent representative, you will keep the highest possible flexibility in your distribution network. Our services will facilitate the fast entrance of your device into the Malaysian market.
Consultancy Support
Establishment License Application
Pursuant to the Malaysia Medical Device Act 2012 (Act 737) that came into effect on 30th June 2013, all Manufacturers, Local Authorized Representative (LAR), Importers and Distributors of medical devices are required to obtain Establishment License and register their medical devices/products with the Malaysia Medical Device Authority (MDA).
T T Medical provides consultancy support in obtaining Establishment License for Manufacturer, Authorized Representative (AR), Importer and Distributor in compliance with the Malaysia Medical Device Regulations 2012.
Our support will also include the development and implementation of ISO13485:2003 and/or GDPMD as specified in the Regulations.
