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Malaysia's Medical Device Regulations 2012 requires Importer, Distributor, Authorised Representative of Foreign Manufacturer to have implemented a Quality Management System that complies with GDPMD requirements as a pre-requisite to apply for Establishment Licence and to perform Product Registration of their products.
Our consultants will assist you in setting up a quality management system which will comply with the GDPMD requirements that enable you to apply for the Establishment Licences (Import or/and Distributor Licence).
Should you need to have your products registered, we also provide product registration service.