April 9th, 2018

Based on a recently issued circular letter, No. 3 Year 2017 (Rev.1), MDA has reiterated the implementation and enforcement date for the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products, which will be strictly enforced in Malaysia starting July 1^st, 2019.

This guideline was released in July 2017, set for implementation starting Q4 next year. According to this, drug-medical device and medical device-drug combinations products are required to fulfil the registration requirement set forth by both Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA).

$1i)     i) Unregistered Combination Products

So, any unregistered combination products which are applied for registration on/after 1^st July 2019, will have to completely comply with the guideline’s requirements

$1ii)    ii) Unregistered Combination Products under evaluation in which application made prior to 1^st July 2019

All unregistered combination products which are applied for registration before 1^st July 2019, will be subjected to this guideline only during the following renewal term.

$1iii)   iii) Registered Combination Products that have already been placed on the market

All registered combination products which are already on the market and will expire on / after 1^st July 2019, will be subjected to this guideline requirements.

More information on this guideline can be consulted at the following link while the circular letter can be viewed here.

Reference:

1)  MDA Circular Letter (No. 3 Year 2017 (Rev.1)): Implementation And Enforcement Of Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products

2)  Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products