Malaysian Fast-track Registration Pathway Unveiled

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.

Malaysia fast-track medical device registration 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).

Manufacturers interested in qualifying for the MDA fast-track registration pathway should apply directly to the MDA via the Medical Device Centralized Online Application System (MeDCASt). Registrants should be prepared to provide all documentation required for standard market authorization applications, but not the following:

  • Details of Conformity Assessment Body
  • Conformity Assessment Certificate
  • Conformity Assessment Report

Fast-track registration applications received after the June 30 deadline will not be considered for this Malaysian market access route.

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