Drug-medical device/medical device-drug combination products are controlled in accordance with the categorization of either as a drug or a medical device depending on the major mode of action. Combination items that are subject to the Medical Device Authority regulation as medical devices must adhere to the standards outlined in the Medical Device Act 2012 (Act 737) and its subsidiary laws, as well as any other relevant MDA publications.

The MDA has announced the release of the Fifth Edition Guidance Document "Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Product”, which is available since January 3rd, 2023. The updated guideline document addresses the following topics in the new edition:

1.  Obtaining Endorsement from MDA for a Drug-Medical Device Combination Product is NOT required for Non-sterile and Non-measuring low risk ancillary medical devices that form a single entity / integrated product with the Drug-Medical Device Combination Product.

2. The application shall be deemed withdrawn and shall not be further pursued, but without affecting the applicant's right to submit a new application, if any additional information, particulars or documents, or sample of the medical device required, are not provided by the applicant within the period specified in the request or any extension of time granted by the Authority.

3. Changes on the category classification in Stage 1 and evaluation timeline by NPRA:

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4. Revision section topic name 6.0 Post-Approval Changes / Variation To Particulars Of A Registered Combination Product and section 7.0 Adverse Drug Reaction and Incident Reporting.

5. Approval type is added in Table 3: Recognised regulatory agencies approval / clearance in Appendix 1: Ancillary Medical Device Dossier Requirement for Drug-Medical Device Combination. Also, updates in Appendix 2, 3, 6, 8 and 7, respectively.



Requirement for Drug-Medical Device and Medical Devie-Drug Combination Products Registration