All Malaysian establishments, ie manufacturer, authorised representative (AR), importer and distributor must apply for establishment licence. However, only manufacturer and AR need to apply for medical device registration.
It is an attestation drawn up by the manufacturer that its medical device fully conforms to all applicable Essential Principles of Safety and Performance (EPSP) of medical device and other requirements of Act 737 and the regulations under it.
Good Distribution Practice for Medical Devices (GDPMD) is by ensuring the quality, safety and performance of medical device during all aspects of medical device supply-chain, which include, but not limited to, product sourcing and procurement; transportation and delivery.
Safety and quality are non-negotiable in the medical devices industry, that’s why ISO 13485 is developed. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.
Our Past workshops in 2023 & 2024:
– MDA Regulatory fulfillment
– Clinical evidence for IVD and AMD
– Technical Documentation on IVD and AMD
– ISO 13485 requirement fulfillment
Assessed, Verified For Acceptance, Trust, Credibility, Quality