1. What are examples of drug-medical device combination product?

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) 

2. Are the requirements in the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products applicable to Natural products and Health Supplement products?
3. What is the risk classification of ancillary medical device component?


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