One more year: Malaysia extends deadline for registering devices
This article was originally published in Clinica
The Malaysian Medical Devices Authority has given medtech companies an additional year to register their devices under the country’s new conformity-assessment-based regulatory system. The original deadline for companies to file with the MDA – and thus allow the products to stay on the Malaysian market – was 30 June 2015, but this has now been extended to 30 June 2016.
The MDA issued an order, known officially as the Medical Device (Exemption) Order 2015, which “exempts any person who has submitted an application for the registration of a medical device between 1 July 2015 until 30 June 2016” from the requirement of Act 737 (the Medical Device Act 2012, which came into force in June 2013). This person, the order states, “may continue to import, export or place in the market the medical device pending determination of the application for registration”.
While the MDA did not give a reason for extending the deadline, it is likely due in part to the regulator to cope with the substantial workload of clearing these applications, in part to companies themselves struggling to get their applications in on time, believes Jack Wong, director of regulatory affairs, Asia-Pacific, at Terumo BCT and founder of the Asian Regulatory Affairs Professionals Association. “Manufacturers have to submit their dossiers using the Common Submission Dossier Template (CSDT), and this takes time and effort to transpose their existing US or EU files to this new format,” Mr Wong told Clinica.
Under Malaysia’s conformity assessment-based system, manufacturers must conduct assessments of their QMS (ISO 13485 or equivalent); for the C and D risk classes, full QMS is required. Manufacturers also have to demonstrate safety and performance via the CSDT and declaration of conformity. Local authorized representatives (LARs), importers and distributors must conform to Good Distribution Practice in Medical Devices.
At the registration phase, manufacturers and LARs need to register the devices (under the four-category A-D risk classification system, where “A” is lowest risk) and obtain licenses for establishments. There is a “small fee” for registration. Distributors also need to apply for distribution licenses and ensure compliance with GDP.