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

ENDORSEMENT LETTER

2. What are the documents required prior to submission?
3. Where shall the applicant submit the required documents?
4. What will the applicant receive after the submission of the endorsement letter?
5. What is the validity of the endorsement letter for ancillary drug component?
6. Will the endorsement letter still be valid at the point of registration approval if there is time gap between the issuance of endorsement letter and the actual approval date of product registration?
7. Is an endorsement letter of ancillary medical device component still required for registration of drug-medical device combination product if the medical device is already registered with Medical Device Authority?
8. Will the name of the combination product be stated in the endorsement letter issued by the Medical Device Authority?
9. Can the endorsement letter of ancillary medical device be used for registration of multiple combination products?
10. Is the endorsement letter of ancillary drug component still required for registration of medical device-drug combination product, if the drug component used is a registered product with Drug Control Authority?
11. Is GMP (Good Manufacturing Practices) compliance evidence for manufacturer of active pharmaceutical ingredient (API)/drug substance required for application of endorsement letter of ancillary drug component?
12. Where should I attach endorsement letter of ancillary medical device component, during registration of drug-medical device combination product?
13. Can API/drug substance manufacturer submit confidential documents for ancillary drug?

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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  • Last Modified: Friday 06 December 2019, 11:24:27.
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