FAQ combo endorsement letter

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

- Continous ambulatory peritoneal dialysis (CAPD) products with CAPD system (e.g. dialysate bage, drainage bag, transfer tubing, linking connector, disc, injection port, overpouch, 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/ wihout dosing control

- Convenience pack products (example: first aid kit consist of medical device and non-scheduled poison products) 

No. The guideline is not applicable to Natural products and Health Supplement products. Kindly refer to Drug Registration Guidance Document available at here for the definition of Natural products and Health Supplement products.

Kindly refer to Guidance on the Rules of Classification for General Medical Devices available at www.mdb.gov.my.

Yes, the name of the combination product will be stated in the endorsement letter. Multiple product names with the same specification of ancillary medical device may be allowed in one application.

Yes, the endorsement letter issued by the NPRA will be valid from the date of issue until 5 years from product registration approval date.

Yes, endorsement letter is required. However, case-to-case basis can be considered if the performance of ancillary medical device is not affected by the drug component.

Yes, the name of the combination product will be stated in the endorsement letter. Multiple product names with the same specification of ancillary medical device may be allowed in one application.

No. It is advised to list all the drug-medical device products which contain the same ancillary medical device, in one application form for endorsement letter of ancillary component.

Yes, it is required for both API and active biological substance. 

Applicant can check on the comments from the ‘remarks’ column in product registration renewal module in QUEST online registration system.

Fill in the application form for endorsement letter of ancillary component with check list of the relevant drug category (New Drug Product, Biologic, Generic) and submit manually to Centre for Product Registration, National Pharmaceutical Regulatory Agency.

You may apply for classification application or refer to definition of each category at available at here.

Endorsement letter of ancillary medical device component can be uploaded at part Product Validation item 18 of Quest 3+ system during product registration application.

Yes. This is in line with the requirements stated in Section 6.2 : Changes/Variation To Particulars Of A Registered Medical Device-Drug Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products.

Kindly refer to 6.0 Changes/ Variation To Particulars Of A Registered Combination Product, Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products available at http://www.npra.gov.my/.

The current policy stipulates the validity period of endorsement letter shall be in line with the validity period of combination product registration. However, this matter will be further scrutinized in variation guideline which is currently under development.

Yes, the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products is applicable during renewal application if the combination product registration ends on/ after 1st July 2019. Hence, the endorsement letter of the ancillary component will be required during renewal of these products.

Endorsement letter of the medical device ancillary component is required to be uploaded at Part I, E14. Other Supporting Documents under the Quest 3+ system during renewal application.