Frequently Asked Questions (FAQs) on Drug-Medical Device Combination Products

GENERAL

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 bage, 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?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Tuesday 25 June 2019, 10:20:49.
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