UNDERSTANDING THE REGULATORY FRAMEWORK FOR MEDICAL DEVICES IN MALAYSIA - MDA AND MDAA
Passed in 2012, the Medical Device Act (MDA) and the Medical Device Authority Act (MDAA) represent the first efforts by Malaysia to implement mandatory safety requirements for medical devices marketed or sold in that country. Regulations under the MDA replaced the country’s voluntary product registration scheme, originally established in 2006, and now require registration of all medical devices manufactured, imported or distributed in Malaysia. The law also provides suitable transition periods for manufacturers to register with the country’s newly established Medical Devices Authority.
REQUIREMENTS UNDER MDA
To register a medical device for sale in Malaysia, a manufacturer must retain the services of a conformity assessment body (CAB) licensed by the Medical Device Authority to review and certify the registration application. As part of the conformity assessment process, the CAB will conduct a technical file review and an audit of the manufacturer’s quality management system. Certified applications are then submitted to the Medical Device Authority through an online registration system for final review and approval.
In addition to these requirements, manufacturers and importers must obtain an “establishment license” in order to legally market or sell medical devices in Malaysia. Manufacturers with no local presence in Malaysia are also required to appoint a Malaysia Authorised Representative, responsible for managing the device registration process and serving as the manufacturer’s legal representative in all dealings related to the review and approval of the device.
WHY CHOOSE TÜV SÜD MALAYSIA
TÜV SÜD Malaysia is a licensed CAB under the MDA, and can conduct all review and assessment activities required to certify a device registration application. TÜV SÜD Malaysia can also conduct an audit of a manufacturer’s quality management system as part of the quality assessment process.
OUR SERVICES AT A GLANCE
- Registration application support - TÜV SÜD Malaysia is a licensed CAB under Malaysia’s MDA, and authorised to evaluate and certify registration applications for medical devices which include technical file review for product registration.
- Quality system audit services - TÜV SÜD Malaysia is also qualified to conduct audits of a manufacturer’s quality management systems, as required by the provisions of the MDA which include Good Distribution Practice of Medical Device (GDPMD) and ISO 13485.
- Other testing and certification services - In addition to testing and certifying medical devices to MDA requirements, TÜV SÜD Malaysia can also provide biocompatibility testing, product safety and EMC testing for medical devices according to relevant standards.