August 13, 2018
It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.
Combination products in Malaysia are defined as:
a) A product comprised of two or more regulated components, i.e., drug/device, biological/device, or drug/device/biological that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Examples of single-entity combination products (where the components are physically, chemically or otherwise combined):
i) Monoclonal antibody combined with a therapeutic drug
ii) Device coated or impregnated with a drug or biologic: e.g: Dermal Fillers with Lidocaine
iii) Drug-eluting stent, pacing lead with steroid-coated tip, catheter with antimicrobial coating, condom with spermicide, transdermal patch
iv) Prefilled drug delivery systems (syringes, insulin injector pen, metered dose inhaler)
b) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products [often referred to as a “co-packaged” combination product].
Examples of co-packaged combination products (the components are packaged together):
i) Drug or vaccine vial packaged with a delivery device
ii) Surgical tray with surgical instruments, drapes, and anaesthetic or antimicrobial swabs
iii) First-aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers)
However, this has sparked for some debates on whether certain group of medical products are considered as medical device, which will be solely regulated by the MDA, or as drug, whereby they will be solely regulated by the NPRA or as combination products, which would be jointly regulated by both MDA and NPRA, based on the primary intended use.
Following this, MDA has released a guideline on correctly classifying Medical Device - Drug - Cosmetic Interphase (MDDCI) Products and the relevant custodian agency regulating these products, based on their intended purpose, indication of use and/or mode of action. These products were initially in the grey area, not easily classified as a medical device, drug or a combination product and the issuance of this guideline has proven very effective in correctly identifying the relevant regulatory authority for its registration and marketing in Malaysia.
This list comprises of 30 groups of MDDCI products along with its classification and relevant regulatory authority mentioned. Furthermore, the list also classifies other non MDDCI products accurately, to avoid further classification confusion. It shall be used as guidance for classification only. Applicant shall verify on MDDCI product classification with either MDA or NPRA in order to determine whether the product shall be registered by the Authority or otherwise. The list can be consulted at this link.