Malaysia Issues Guidance on Combination Product Registration

The Malaysian government has released guidance for registration of drug-medical device and medical device-drug combination products.

The government agency for registration of combination products is based on the primary mode of action by which the claimed effect or purpose of the product is achieved. A medical device that does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means would be regulated by the Medical Device Authority (MDA).

A drug, with a PMOA based on pharmacological, immunological or metabolic action in or on the body, would be regulated by the National Pharmaceutical Regulatory Agency (NPRA).

In cases where the NPRA is the primary regulator, a combination product must first obtain certification from a Conformity Assessment Body (CAB), then endorsement from the MDA, and finally apply for registration with the NPRA before commercialization.

For combination products whose primary regulator is the MDA, obtaining an NPRA endorsement is the first step, followed by CAB certification and finally MDA registration.

Malaysian regulators have set July 1, 2018 as the registration deadline for any unregistered combination product.

Read the guidance here: www.fdanews.com/04-21-17-MinistryHealthMalaysia.pdf. — William Schulz