Malaysia Drug–Medical Device Combination Products: A Guide to Classification & Regulatory Pathways

Drug–medical device combination products present a unique regulatory challenge in Malaysia because they combine two product categories that are traditionally governed under separate regulatory systems. Unlike conventional products that fall clearly into either the pharmaceutical or medical device category, combination products integrate elements of both.

To address this complexity, Malaysia applies a coordinated regulatory framework built around a central concept: the Primary Mode of Action (PMOA). The PMOA determines which regulatory authority leads the evaluation process while ensuring that both the drug and device components are assessed according to the appropriate standards.

For manufacturers and importers, understanding this classification system is the first step in building an effective regulatory strategy.

Continue below for a complete overview of Malaysia’s regulatory pathway for combination products, or contact Cisema for assistance with regulatory compliance and market entry.

What Are Drug–Medical Device Combination Products in Malaysia?

Drug–medical device combination products are products that integrate both a pharmaceutical component and a medical device component into a single system or product configuration.

These products are increasingly common across healthcare sectors because they bring together therapeutic and mechanical functions in one integrated solution. Examples may include drug-eluting devices, pre-filled injection systems, or delivery platforms that administer a pharmaceutical product through a device mechanism.

However, combining these two product categories raises an important regulatory question: which component delivers the product’s primary therapeutic effect?

Malaysia answers this question through the concept of the Primary Mode of Action.

The PMOA refers to the mechanism responsible for producing the product’s main therapeutic outcome. Regulators evaluate how the product works to determine whether the principal effect occurs through:

• Pharmacological action
• Immunological action
• Metabolic action
• Non-pharmacological device-based mechanisms

Once the PMOA is established, the next question becomes clear: which Malaysian authority takes the lead once the Primary Mode of Action has been identified?

Which Authorities Regulate Combination Products in Malaysia?

In Malaysia, oversight of combination products is shared between two regulatory bodies:

• National Pharmaceutical Regulatory Agency (NPRA)
• Medical Device Authority (MDA)

Both authorities play a role in the regulatory framework, but the Primary Mode of Action determines which agency leads the evaluation process.

When NPRA Leads the Review: Drug–Medical Device Combination Products (DMDCP)

Products classified as Drug–Medical Device Combination Products are regulated primarily by the NPRA. This classification applies when the product’s main therapeutic effect is achieved through:

• Pharmacological action
• Immunological action
• Metabolic action

In these cases, the drug component drives the therapeutic outcome, placing the product under NPRA’s primary regulatory oversight.

When MDA Leads the Review: Medical Device–Drug Combination Products (MDDCP)

Products categorized as Medical Device–Drug Combination Products (MDDCP) fall under the authority of the MDA.

This pathway applies when the product’s main therapeutic effect is not pharmacological, immunological, or metabolic. Instead, the device component provides the principal therapeutic function.

Although one authority leads the evaluation, both regulators may participate in the review to ensure that each component meets the applicable regulatory requirements.

Why Both NPRA and MDA Review Combination Products

Malaysia’s regulatory approach ensures that each component of a combination product is evaluated by the authority responsible for that product category.

Under this dual-agency model:

• The authority responsible for the primary component conducts the main regulatory evaluation.
• The second authority reviews the ancillary drug or device component.

Before final registration can be granted, the secondary authority must issue an endorsement letter confirming that the ancillary component meets the relevant regulatory requirements.

Because of this structure, manufacturers developing combination products may need to coordinate submissions and regulatory communication with both NPRA and MDA during the approval process.

With the regulatory roles defined, manufacturers can then proceed to the product registration process.

How Are Combination Products Registered in Malaysia?

In Malaysia, combination product approval follows a structured process that coordinates review between the lead authority and the secondary regulator.

The process generally involves several key stages:

1. Determine the Primary Mode of Action (PMOA)

Manufacturers must first establish the mechanism responsible for the product’s primary therapeutic effect. This determination identifies whether NPRA or MDA will lead the review.

2. Submit the Registration Dossier to the Lead Authority

The manufacturer submits a product dossier to the authority responsible for the primary component. The submission must include documentation covering both the primary and ancillary components.

3. Ancillary Component Review by the Secondary Authority

During evaluation, the secondary regulator reviews the ancillary component to confirm compliance with the relevant regulatory requirements.

4. Issuance of an Endorsement Letter

The secondary authority issues an endorsement letter once the ancillary component has been evaluated and found compliant.

5. Final Approval and Product Registration

After both evaluations are complete, the lead authority may grant final registration.

Regulatory Guidance Supporting the Registration Process

The procedures governing these steps are described in the NPRA document “Guideline for Registration of Drug–Medical Device and Medical Device–Drug Combination Products.” The guideline outlines procedures governing both product registration and lifecycle management.

Key areas addressed in the guideline include:

• Registration procedures for combination products, including staged submissions to both the primary and secondary regulatory agencies
• Dossier requirements covering both the primary component and the ancillary component
• Evaluation timelines and regulatory fees imposed by NPRA and MDA
• Post-approval changes and variations affecting ancillary components
• Adverse drug reaction (ADR) and incident reporting requirements, including defined reporting timelines and submission procedures

If discrepancies arise between guidance documents and legal instruments, the following legislation takes precedence:

• Medical Device Act 2012 (Malaysia)
• Control of Drugs and Cosmetics Regulations 1984 (Malaysia)

These legal instruments remain the binding regulatory framework governing combination products in Malaysia.

Although registration represents the key milestone in obtaining market authorization, regulatory oversight continues after approval through Malaysia’s post-market surveillance system.

Post-Market Surveillance for Combination Products in Malaysia

Malaysia’s regulatory framework includes defined procedures for monitoring combination products after they are placed on the market. Post-market surveillance systems are designed to identify and address safety issues that may emerge during real-world use.

The NPRA guideline for the registration of drug–medical device and medical device–drug combination products outline responsibilities for several stakeholders involved in product commercialization, including:

• Product Registration Holders
• Manufacturers
• Authorized Representatives
• Distributors

These stakeholders must follow defined reporting pathways and timelines when submitting adverse drug reaction (ADR) reports or incident notifications.

Through these mechanisms, regulators can maintain continuous oversight of product safety throughout the product lifecycle. Because these monitoring obligations continue after registration, companies must be prepared to maintain compliance systems that support reporting requirements once products are commercialized.

For companies entering the Malaysian market, preparing these systems early helps ensure that reporting obligations can be met without disruption.

Key Compliance Considerations for Foreign Manufacturers

For international manufacturers planning to commercialize combination products in Malaysia, the regulatory framework highlights the importance of early regulatory planning.

Since the Primary Mode of Action determines the regulatory pathway, classification decisions made early in product development can significantly influence the registration strategy and approval timeline.

With this in mind, manufacturers should focus on several core areas when preparing for Malaysian market entry.

Conduct a Structured PMOA Assessment During Development

For combination products, determining the PMOA is not always straightforward. Products that deliver therapeutic effects through both mechanical and pharmacological mechanisms may require careful analysis to identify which component regulators will consider primary.

Conducting a structured PMOA assessment during product development helps manufacturers anticipate the likely regulatory pathway and avoid classification uncertainty later in the process. In some cases, early regulatory consultation or internal regulatory strategy reviews can help confirm assumptions about how regulators may interpret the product’s mechanism of action.

Clarifying the PMOA early also allows manufacturers to design their regulatory documentation and evidence package in a way that aligns with the expectations of the lead authority.

Align Technical Documentation with the Lead Authority’s Review Focus

Once the regulatory pathway is understood, manufacturers should ensure that their submission dossier reflects the evaluation priorities of the lead authority, while still addressing the requirements of the secondary regulator.

This may affect how certain elements of the dossier are structured. For example, the depth of clinical, pharmacological, or performance data presented may need to correspond with the component delivering the primary therapeutic effect. At the same time, the ancillary component must still demonstrate compliance with the relevant regulatory standards applicable to that product category.

Approaching dossier preparation with this dual-review structure in mind can help reduce requests for additional information during the evaluation process.

Plan for Coordination Between Regulatory Authorities

Because both NPRA and MDA participate in the review process, manufacturers should anticipate coordination between two regulatory evaluations rather than a single approval pathway.

This coordination can affect submission sequencing, evaluation timelines, and the issuance of the endorsement letter required before final approval. Understanding how these interactions occur can help manufacturers develop more realistic regulatory timelines.

For companies entering the Malaysian market for the first time, navigating these parallel regulatory interactions can be complex. Working with a local regulatory specialist, such as Cisema, can help streamline submissions, coordinate communication with both authorities, and ensure that documentation aligns with regulatory expectations.

Moving Forward with Combination Product Registration in Malaysia

Successfully registering a combination product in Malaysia requires careful coordination between product classification, technical documentation, and regulatory submission strategy. Clear presentation of the product’s components, and their respective roles in delivering the therapeutic effect, can help facilitate a smoother review process.

In practice, successful registrations often hinge on how clearly the product’s components, and their respective roles, are presented during regulatory review. Well-structured documentation, aligned with the expectations of the lead authority while addressing the requirements of the ancillary component, can significantly reduce requests for clarification and streamline the evaluation process.

For companies unfamiliar with Malaysia’s regulatory landscape, working with experienced local specialists can help simplify the process. Regulatory partners such as Cisema support international manufacturers in preparing compliant submissions, coordinating interactions with NPRA and MDA, and guiding products through the Malaysian approval pathway from initial classification to market authorization.

For expert guidance on drug–medical device combination product registration and regulatory compliance in Malaysia, contact Cisema today.

Further Information

• Explore Cisema’s services for medical device registration in Malaysia.
• You may also find our guide helpful: Medical Device Registration in Malaysia: A Practical Guide for Foreign Manufacturers with Latest Timelines, Fees & Tips.

About the Author: Shouzheng Tan

Shouzheng Tan is Vice President of Southeast Asia at Cisema, based in Penang, Malaysia. He brings more than a decade of experience in the medical device industry, specializing in regulatory registration and market access across Southeast Asia. In his role, he works closely with overseas manufacturers to develop and implement effective regulatory strategies for medical devices throughout the region, including key markets such as Malaysia. His expertise is complemented by working knowledge of quality management systems, allowing him to support clients across both regulatory and compliance requirements.