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 1st, 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 1st 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 1st July 2019
All unregistered combination products which are applied for registration before 1st 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 1st 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.
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