Drug‑Medical Device and Medical Device-Drug Combination products; (ICS: 11.040, 11.120).

Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products (33 page(s), in English; 3 page(s), in Malay)

This 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.