Establishment Licence Overview
Overview of establishment licensing requirements under Malaysia's Medical Device Act 2012 (Act 737) for manufacturers, importers, and distributors.
Manufacturer Licence
Requirements for obtaining a manufacturer establishment licence under Malaysia's Medical Device Act 2012, including QMS, GMP, and application documentation.
Importer Licence
Requirements for importing medical devices into Malaysia, including importer establishment licensing, QMS expectations, and post-market responsibilities.
Distributor Licence
Distributor establishment licensing requirements in Malaysia, including storage, traceability, and supply chain obligations under Act 737.
Local Authorised Representative (LAR)
LAR requirements for foreign manufacturers, including appointment, responsibilities, legal obligations, and eligible entities under Malaysia's Medical Device Act 2012.
MyMDA Portal — Establishment Licensing
Step-by-step guide to applying for an establishment licence via the MyMDA online portal, including document preparation tips and common pitfalls.