Malaysia: MDA Released Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products
On 11 January 2023, the Medical Device Authority (MDA) of Malaysia released the Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products. The revised guideline document covers the following matters :
- Revision on Changes/Variation to Particulars of a Registered Combination Product.
- Revision of Post-Marketing Activities: Management of Incident Involving Registered Combination Product By The Industry
- Addition of Requirement under Registration Process of Combination Product
- For non-invasive (external use and/ or localised effect) medical device, an endorsement from NPRA for Medical Device-Drug Combination NOT required.
- Addition of statement under Stage 1: Obtaining Endorsement from MDA and Stage 2: Application for Registration to MDA
- Revision on Timeline for Registration of Combination Product
- Revision on Fees Imposed by NPRA
Further information on the released Fifth Edition Guideline Documents For Drug-Medical Device And Medical Device-Drug Combination Products, please refer to this link.
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