August 13, 2018

The Medical Device Authority (MDA) has been set on stricter implementing and enforcing the Medical Device Act 2012 (Act 737) via the gradual introduction of various policies. In 2016, it issued a policy providing a transition period of two (2) years for all local and foreign manufacturers importing, distributing and marketing medical devices in Malaysia to comply with the requirements of labelling in accordance with the Sixth Schedule of Medical Device Regulations (MDR) 2012. This policy allowed for medical devices with labels which did not entirely follow the regulations set by MDR 2012 to be still in the commercial circulation, until 5th August 2018.

Fortunately, the MDA came up with a new policy on 5th August 2018, regarding this matter. The Circular Letter No. 5 of Year 2018 mentions that MDA has decided for implementation of an additional 3 year transition period for all local and foreign medical device establishments to meet the requirements of labelling in accordance with the MDR 2012, commencing from 5th August 2018 until 5th August 2021. The existing labelling which may not entirely adhere to the Sixth Schedule of MDR 2012 may still be used in this new period, before stricter implementation of the regulation comes into force.

Following 5th August 2021, any failure to follow the labelling requirements, as inscribed in the Sixth Schedule of MDR 2012 will result in a fine not exceeding ten thousand ringgit or imprisonment for a term not exceeding three months or both. The new Circular Letter can be consulted in this link.



Circular Letter No. 5 of Year 2018: Additional Transition Period for Medical Device Labelling