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.