Life Sciences Malaysian Medical Device Regulations (MYMDR)
Meet the Malaysian Medical Device Regulations (MYMDR) and sell products in Malaysia with a certification audit from SGS.
To sell medical devices in Malaysia, manufacturers, exporters, importers, distributors and local authorized representatives must meet the MYMDR set down by the country’s Medical Device Authority (MDA). Since July 1, 2013, the MDA requires medical device manufacturers, exporters, importers, distributors and local authorized representatives to register their products as part of the Medical Devices Act 2012. They must meet the Malaysian Medical Devices Regulations in order to sell medical devices in Malaysia.
As specified in the Medical Device Act 2012 (Act 737), the industry is granted a transition period of two years for medical device registration, while one year is granted for establishment licensing before it is fully enforced by the MDA. Manufacturers must implement an appropriate quality management system for product manufacturing, while importers/distributors should ensure compliance to Good Distribution Practices for Medical Devices (GDPMD).
We are one of the leading Conformity Assessment Bodies (CAB) registered with the MDA. We can assess both manufacturers and local authorized representatives against the ISO 13485 quality system, and assess distributors and parties involved in the medical device supply chain for compliance against with GDPMD.
Our knowledge and experience in the medical devices and supply chain market make us the partner of choice for audits against the required standards.
Support your organization’s entry into Malaysia’s medical devices market through compliance with the Malaysian Medical Device Regulations, with certification from SGS.