NPRA or MDA? Drug–device combination products, decided.

The test is the primary mode of action.

Section 2 of Act 737 defines a medical device as one that does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, although it may be assisted by them. The Ministry of Health’s joint Guideline for Drug-Medical Device and Medical Device-Drug Combination Products (Fifth Edition, revised 17 October 2024) turns that into a single test: the primary mode of action (PMOA), meaning the action that makes the greatest contribution to the product’s overall therapeutic effect.

• Drug–medical device combination product (DMDCP): the PMOA is pharmacological, immunological or metabolic. NPRA is the primary agency and the Drug Control Authority registers it under the Control of Drugs and Cosmetics Regulations 1984.
• Medical device–drug combination product (MDDCP): the PMOA is not pharmacological, immunological or metabolic, and the drug only assists. MDA is the primary agency and registers it under Act 737.

Either way the product is registered once, by the primary agency. The secondary agency reviews only its own component and issues an endorsement letter. The guideline has been enforced since 1 July 2019, and its incident-reporting section since 1 July 2022. On MDA’s side it is run by the Combination Product Unit of the Pre-Market Control Division.

Decisions MDA and NPRA have already made

The Medical Device–Drug–Cosmetic Interphase (MDDCI) table, updated 10 February 2025 and linked from MDA’s product classification page, lists products the joint committee has classified. MDA says it is guidance for classification only, but it is the first place to look.

Where MDA leads, the class follows Rule 13 of the First Schedule, Medical Device Regulations 2012: a device incorporating a substance that would be a medicinal product on its own, acting ancillary to the device, is Class D. The Regulations’ own examples are antibiotic bone cement, heparin-coated catheters, antimicrobial wound dressings and blood bags with anticoagulant. Our classification guide covers the rules in full, and fillers are covered in aesthetic device registration.

What counts as a combination product

Two or more regulated components (drug and device, biological and device, or all three) that are either combined into a single entity or co-packaged as a unit. The guideline excludes, and regulates separately:

• a drug, device or biological product packaged separately but labelled for use only with another specified approved product;
• separately packaged investigational products intended for use together;
• convenience packs, such as a first-aid kit holding a medical device and a non-scheduled poison;
• natural products and health supplements.

MDA’s combination-product FAQ adds products that are regulated as a drug only, not as a combination: nasal sprays with or without dosing control, a dropper that is part of the drug’s container, eye, ear and nose drop packs, applicators for the skin or a body orifice without dosing control, and nail brushes.

The two routes, step by step

Both stages may be filed at the same time, but the primary agency approves only once the secondary agency’s endorsement letter has arrived. If MDA asks for more information, the applicant has 90 days to answer before the application is treated as withdrawn. NPRA’s FAQ says it may reject an endorsement application if the applicant does not respond within six months or fails to meet the requirements after three rounds of correspondence. The device-led route uses the same conformity assessment body stage as any other MDA registration.

When Stage 1 can be skipped

• No MDA endorsement needed (drug-led): low-risk ancillary devices co-packed in the secondary packaging and not forming a single entity (an oral syringe without needle, spoons, measuring cups, inhalers, spacers); non-sterile, non-measuring low-risk devices that form a single entity with the drug; and ancillary devices already registered with MDA, where the registration certificate goes to NPRA instead. NPRA’s FAQ adds that Class A ancillary devices need no MDA endorsement letter.
• No NPRA endorsement needed (device-led): non-invasive devices for external use or a localised effect, such as skin barrier lotions, emulsions, ointments and creams, irrigation solutions and dressings comprising a matrix. These go straight to Stage 2 with MDA.

What MDA reviews in the ancillary device dossier

Appendix 1 of the guideline sets twelve elements, explained by reference to the CSDT (MDA/GD/0008): a device overview stating whether the product is single-entity or co-packed; labelled pictures; accessories; the IFU; contraindications, warnings and precautions; materials in contact with the body; three years of marketing history; three years of reportable adverse events and field corrective actions (or a declaration of no safety issues); design verification and validation, including biocompatibility and clinical evidence; risk analysis; manufacturing information with the QMS (GMP or ISO 13485); and the essential principles with the method used to show conformity.

• Abridged route. One approval from a reference agency is enough (MDA FAQ): TGA, Health Canada, the EU (EMA or an EU competent authority, CE certification under the MDD, AIMDD, IVDD, MDR or IVDR, or a notified body’s Article 117 opinion), Japan (PMDA, MHLW or a registered certification body), the US FDA (NDC, 510(k) or PMA) or the UK MHRA. Contraindications, materials and risk analysis then become optional.
• Accepted shortcuts. For a single-entity product, MDA accepts a risk analysis and IFU written for the finished combination product. An EU Essential Requirements Checklist is accepted as support; a bare list of standards is not. Manufacturing information can be left out only if the device is co-packaged and approved as a device in a reference country.
• Reuse. An endorsement letter can cover further drug applications with the same device brand and submission type, provided the drug does not affect the device’s performance.

Fees and timelines

Times run from a complete application, and each agency runs its own clock, so the guideline tells applicants to plan for the combined total. MDA’s endorsement fee is invoiced by email once the application is complete and paid through BayarNow (no cash); the MDA registration fee is paid by FPX in MeDC@St 2.0+. The RM5,000 registration fee compares with RM3,000 for a standard Class D device under the Fifth Schedule.

Changes after approval

• Drug-led: changes to the drug follow NPRA’s variation rules. Changes to the ancillary device go to MDA manually with the Appendix 4 form; MDA issues an approval letter, which is then sent to NPRA. This is not mandatory for low-risk ancillary devices, or for devices already registered with MDA whose change notification MDA has approved. A change that affects safety or performance and is not listed needs a new endorsement letter.
• Device-led: changes to the device follow MDA’s change notification rules (MDA/GD/0020). Changes to the ancillary drug go to NPRA under its variation guidelines, and NPRA’s approval letter is sent to MDA.

Incidents: who you report to

If the nature of the incident cannot be determined, report to both. The guideline’s own deadlines for combination products are counted in calendar days from discovery: 48 hours for a serious threat to public health, 10 days for an incident that caused or could cause death or serious deterioration in health, and 30 days for product failure, deterioration in effectiveness or inadequate labelling. For foreign events, a significant safety issue is due within 3 days and a withdrawal or suspension of registration anywhere within 24 hours. The investigation report is due within 30 days, or as the agency directs, and a report is treated as accepted if the primary agency gives no feedback within 45 days and no further action is needed. The device-side rules are in our mandatory problem reporting guide.

Borderline products: drug, cosmetic or device?

MDA/GD/0063 defines borderline products as those hard to distinguish from a medical device, such as possible medicines, cosmetics, food supplements, biocidal products or personal protective equipment. The MDDCI table lists four criteria: the primary intended purpose, the primary mode of action, the active ingredient, indication and dosage form, and how reference countries classify the product. ASEAN decisions published in MDA/GD/0063 (Third Edition, June 2025) include:

More on how ASEAN reaches these decisions is in our AMDD guide. If your product is not listed, there are two ways to get a ruling:

1. Drug or cosmetic versus device: NPRA first. The MDDCI flowchart sends unlisted products to NPRA for classification (product classification form NPRA 300.1). NPRA issues a notification letter; if it says the product is a medical device, you take that letter to MDA.
2. Device or not, with no drug question: MDA. MDA’s Product Classification Application costs RM300 for up to 10 products sharing one name, intended use and manufacturer. The letter comes within 30 working days of cleared payment and complete documents, and letters issued from 1 October 2026 are valid for 5 years. It says whether the product is a medical device, not its risk class.

Registration numbers and status checks

A combination product carries one registration, from its primary agency. A drug-led product carries an NPRA product registration number; MDA’s published list of endorsed drug–medical device products for 2023 quotes these in the MAL format (for example MAL20091923ACZ). A device-led product receives an MDA medical device registration certificate. Check drug status on NPRA’s product search and device status on MDA’s public register, “Check Medical Device Status”.