Malaysia proposed guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products

National Pharmaceutical Regulatory Agency (NPRA) proposed guideline serves as a guidance for the submission of registration application of drug-medical device/medical device-drug combination products.

Combination products which has not been registered:

-Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products applicable for product registration application submitted on/after 1 July 2019.

Combination products registration application submitted before 1 July 2019 and still in evaluation:

-Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products applicable during re-registration.

Combination products which has been registered and available in market:

-Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products applicable during re-registration for product expired on/after 1 July 2019.

Products covered: Drug Medical Device and Medical Device-Drug Combination products

HS code: 30, 90

Proposed date of adoption: NA

Proposed date of entry into force: 07-07-2019

Final date for comments: 22-12-2018

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.