Malaysia’s guideline for registration of combination products

Malaysia has fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products.

Medical devices with substances incorporated when used on their own could be considered as a medical product, must adhere to this regulation.

Falling under Class D, Rule 13 of the Medical Device Regulation 2012. A medical device-drug combination product registration requires a 3 stage process:

Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)

  • Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
  • Ancillary Drug Dossier (Appendix 2)

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)

Submitting the documentation to the CAB, CAB to issue a certificate and report upon satisfactory assessment.

Stage 3 – Application for Registration to MDA

After obtaining the endorsement letter from the NPRA, certificate, and report from the CAB, an application can be made on Medcast 2.0 for the MDA to evaluate the medical device application.