Seeking to quell confusion over which of its regulatory agencies has purview over medical devices that are used in combination with pharmaceuticals, Malaysia’s Medical Device Administration (MDA) has released guidelines for classifying such products.
The combination products, known as Medical Device Drug Cosmetic Interphase (MDDCI) products, have been difficult to register in Malaysia, where the regulatory system is relatively new. Because a MDDCI is comprised of both a medical device and a drug, both applicants and authorities have found it challenging to determine whether this type of product should be regulated by the MDA or its counterpart for drug approvals, the National Pharmaceutical Regulatory Agency (NPRA).
The new guidelines classify existing MDDCI products into 30 groups and indicate the agency in charge of regulating each group. Authorities say the list is not designed to be exhaustive, and will continuously evolve. It is expected to provide much needed guidance to applicants.