Examples of drug-medical device combination products, of which the drug categories are New Drug Products, Biologics and Generics are as follows:
- Prefilled drug delivery systems (syringe without needle for oral use*, syringe for injection, insulin injector pen, metered dose inhaler)
- Drug packed with measuring spoon/ cup*,
- Drug packed with dropper*, of which it is not a part of the container / packaging
- Continuous Ambulatory Peritoneal Dialysis (CAPD) products with CAPD system (e.g. dialysate bag, drainage bag, transfer tubing, linking connector, disc, injection port, over pouch, etc.)
Note: * - All Class A ancillary medical devices do not require endorsement letter from the Medical Device Authority (MDA) for the purpose of registration of Drug-Medical Device Combination Products
Examples below are not considered as drug-medical device combination product:
- Drug packed with dropper for internal / external use; of which it is a part of the container / packaging
- Eye / ear / nose drops (multiple or single use packing)
- Drug packed with applicator for skin / external body orifice (nostril, mouth, ear canal, anus and vaginal) without dosing control.
- Nasal spray with / without dosing control
- Convenience pack products (example: first aid kit consist of medical device and non-scheduled poison products)
