Malaysia’s Medical Device Registration Transition Period Winding Down
The transition period for medical device registrations in Malaysia is coming to a close, after which Malaysian market applicants will have to submit substantially more paperwork to regulators in order to obtain registration.
Emergo consultants in Kuala Lumpur recently attended a seminar hosted by the Malaysian Medical Device Authority (MDA) where cessation of the regulator’s Exemption Order and Fast Track registration options was discussed.
Up to now, the MDA had allowed market registrants to begin selling their devices in the country in parallel with regulatory review of their applications under what was known as the MDA Exemption Order. The Exemption Order is set to expire on June 30, 2016, after which point medical device companies will have to wait until final MDA approval of their registrations to begin marketing their products.
In addition, the MDA has already rescinded its Fast Track option, which had allowed eligible manufacturers to commercialize their devices in Malaysia without first obtaining Conformity Assessment Body (CAB) certifications provided that those firms obtained such certification within five years of their device approvals. Starting June 30, 2016, registrants must obtain CAB certification before marketing of their devices in Malaysia can occur. The MDA will reject any registration submissions that do not include CAB reports.