Malaysian Fast-track Registration Pathway Unveiled
Friday, April 10, 2015
Medical device market regulators in Malaysia have set rules for a fast-track registration process available for some medical devices between April 10 and June 30, 2015.
The Malaysian Medical Device Authority (MDA) has identified all Class A medical devices as well as Class A, B, C and D devices already registered in the US, Europe, Canada, Japan or Australia as eligible for fast-track registration.
The MDA will postpone Conformity Assessment Body (CAB) certification requirements for qualifying devices for five years; however, fast-tracked device manufacturers must engage CABs within three years from July 1, 2015, and obtain full CAB certification within five years (by June 30, 2020).