Selling Medical Devices in Malaysia
- Roger Pay
- Aug 14, 2025
- 8 min read
Medical Devices
In the context of the Malaysian market, the term "medical device" is defined broadly and regulated strictly by the Medical Device Authority (MDA). The legal framework is established under the Medical Device Act 2012 (Act 737) and its subsidiary regulations.
What is a Medical Device?
According to the MDA, a medical device is any instrument, apparatus, implant, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific medical purposes.
These purposes include, but are not limited to:
Diagnosis, prevention, monitoring, treatment, or alleviation of a disease.
Diagnosis, monitoring, treatment, or compensation for an injury.
Investigation, replacement, modification, or support of the anatomy or a physiological process.
Supporting or sustaining life.
Control of conception.
Disinfection of medical devices.
Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
The key distinction is that a medical device does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means.
Types of Medical Devices
The medical device industry in Malaysia is diverse, encompassing a wide range of products from simple consumables to complex, high-tech equipment. Examples of medical devices sold in Malaysia include:
Consumables: Surgical gloves, catheters, syringes, needles, surgical masks, and other personal protective equipment (PPE). Malaysia is a major global producer of gloves and catheters.
Implants: Orthopedic implants, dental implants, heart valves, pacemakers, and intraocular lenses.
Surgical Instruments: Simple surgical tools like retractors and scissors, as well as complex endoscopes and surgical robots.
Diagnostic Equipment: X-ray machines, ultrasound diagnostic systems, MRI scanners, and other diagnostic imaging equipment.
In Vitro Diagnostic (IVD) Devices: These are devices used to examine specimens derived from the human body, such as blood or urine, to provide information for diagnosis. Examples include blood glucose self-testing kits and HIV blood screening tests.
Therapeutic Devices: Ventilators, dialysis machines, and other life-supporting equipment.
Health and Wellness Devices: Blood pressure cuffs, stethoscopes, wheelchairs, and other aids.
Software: Standalone software used for medical purposes, such as image analysis or patient monitoring, is also classified as a medical device.
Medical Device Classification
The MDA classifies medical devices into four risk classes based on the level of risk they pose to the patient and public health. This classification is a critical step as it determines the registration requirements and the stringency of the regulatory process.
The risk classes are:
Class A (Low Risk): Devices that pose minimal risk. Examples include tongue depressors, simple surgical instruments, and stethoscopes.
Class B (Low-Moderate Risk): Devices with a low to moderate risk. Examples include hypodermic needles and suction equipment.
Class C (High-Moderate Risk): Devices that pose a high-moderate risk. Examples include lung ventilators and orthopedic implants.
Class D (High Risk): Devices with the highest risk. Examples include heart valves and implantable defibrillators.
In addition to general medical devices, IVD devices also follow a similar risk-based classification system, with Class A being the lowest risk and Class D being the highest. The classification depends on factors like the intended use of the device, the expertise of the user, and the impact of the test results on public health.
Selling Medical Devices in Malaysia
Selling medical devices in Malaysia requires a thorough understanding of the country's regulatory framework, market dynamics, and a clear strategy for market entry. Here's a comprehensive overview of what you need to know:
1. Regulatory Framework and Requirements
The sale of medical devices in Malaysia is strictly regulated by the Medical Device Authority (MDA), a statutory body under the Ministry of Health. The regulations are governed by the Medical Device Act 2012 (Act 737) and its subsidiary legislation.
Key Regulatory Steps:
Establishment License: All entities involved in the medical device supply chain—manufacturers, authorized representatives, importers, and distributors—must obtain an Establishment License from the MDA.
Medical Device Registration: All medical devices, unless exempted, must be registered with the MDA before they can be legally imported, exported, or sold in Malaysia.
Authorized Representative (AR): Foreign manufacturers must appoint a local, licensed company to act as their Authorized Representative (AR). The AR is responsible for managing the registration process and is the official license holder.
Classification: Devices are classified into four risk classes (A, B, C, and D) from low to high risk. This classification determines the stringency of the registration process.
Conformity Assessment: For devices in classes B, C, and D, a conformity assessment must be conducted by a registered Conformity Assessment Body (CAB). This ensures the device complies with safety and performance principles.
Technical Dossier: The registration application, submitted through the online MeDC@St2.0+ system, requires a technical dossier in the Common Submission Dossier Template (CSDT) format. This includes device descriptions, pre-clinical and clinical studies, risk analysis, and proof of a quality management system.
Good Distribution Practice for Medical Devices (GDPMD): Importers and distributors must have a valid GDPMD certification, which specifies requirements for a quality management system to maintain the safety and performance of devices throughout the supply chain.
Labeling Requirements: Labels for lay-use devices must be in Bahasa-Malay (and may also include English). They must also include the MDA registration number and the contact information of the Malaysia AR.
2. Market Overview and Trends
Malaysia's medical device market is robust and growing, presenting significant opportunities for foreign manufacturers.
Market Size: The Malaysian medical device market is one of the largest in Southeast Asia and is projected to reach US$3.3 billion by 2028, with a projected growth rate (CAGR) of around 7-9%.
Import-Driven: The market is heavily dependent on imports, with approximately 95% of devices being sourced from abroad. This is particularly true for high-end and technologically advanced products like pacemakers, stents, and diagnostic imaging equipment.
Key Drivers: Market growth is fueled by several factors, including:
A growing and aging population.
An increasing prevalence of chronic diseases.
Rising health consciousness and affluence among the population.
Significant government investment in public healthcare and the modernization of facilities.
A thriving medical tourism industry, especially in specialties like cardiology and orthopedics.
Government Initiatives: The Malaysian government, through its New Industrial Master Plan 2030 (NIMP), is actively promoting the medical device sector and encouraging local manufacturing of higher-value-added products.
3. Market Entry Strategy for Foreign Manufacturers
Foreign companies have several options for entering the Malaysian market:
Appoint a Local Importer or Distributor: This is a common and practical approach. You must choose a local partner with a valid Establishment License, GDPMD certification, and an account on the MeDC@St system. This partner can manage the importation and distribution of your devices.
Appoint an Authorized Representative (AR): If you don't have a local presence, you must appoint an AR to handle the device registration process. Your AR can then authorize one or more licensed importers or distributors to bring your products into the country.
Establish a Local Subsidiary: For greater control over market operations, you can set up a wholly-owned subsidiary in Malaysia. This provides a direct channel for registering and marketing your devices but requires a significant investment of resources.
Summary
Successfully selling medical devices in Malaysia requires navigating a clear, but complex, regulatory process overseen by the MDA. By partnering with a knowledgeable local Authorized Representative and ensuring all products and establishments are properly licensed and registered, you can access a dynamic and growing market driven by strong economic fundamentals and government support for the healthcare sector.
Bestar Professional Fees
Professional fee for Bestar for medical device registration depends on the scope of services provided, and the complexity and risk classification of the medical device being registered.
Fee Structure
Consulting fees are not fixed and can be charged in a few different ways:
Project-Based Fees: This is the most common model for device registration. Bestar offers a fixed fee for the entire registration process, which includes services like preparing the technical dossier, liaising with the Medical Device Authority (MDA), and managing the submission on the MeDC@St system. For a single device, this can range from USD 1,200 to USD 2,400, and even higher for complex devices.
Retainer or Package Deals: For foreign manufacturers, Bestar serves as the Authorized Representative (AR). The fee for this role is usually an annual retainer that covers a range of services, including managing device registration, post-market surveillance, and other compliance obligations. The cost of this retainer varies based on the number and type of devices.
Factors Influencing the Cost
Device Classification: Higher-risk devices (Class B, C, and D) require more extensive documentation and a Conformity Assessment Body (CAB) report, which increases the complexity and, therefore, Bestar's fee.
Scope of Services: The fee will be higher if Bestar is responsible for more than just the MDA submission. Additional services could include:
Acting as the official Authorized Representative.
Preparing or reviewing the full technical dossier (CSDT).
Handling post-market surveillance and reporting.
Providing support for changes in ownership or device re-registration.
When budgeting, it's crucial to distinguish between Bestar's professional fees and the official fees paid to the MDA and other bodies.
How Bestar can Help
Hiring Bestar in Malaysia can be a strategic move for medical device companies, especially for foreign manufacturers new to the market. Bestar offers specialized expertise and services that can significantly streamline the registration process and ensure ongoing compliance. Here's how we can help:
1. Act as the Authorized Representative (AR)
For foreign manufacturers, the most critical role of Bestar is acting as the Authorized Representative (AR). The AR is a mandatory, licensed local entity that serves as the official liaison between the manufacturer and the Medical Device Authority (MDA). As your AR, Bestar can:
Hold the Registration: We will hold the official medical device registration on your behalf.
Manage Communication: We handle all correspondence and inquiries from the MDA, ensuring timely and accurate responses.
Serve as a Local Presence: This allows you to legally market and sell your devices in Malaysia without having to establish a physical office or local subsidiary.
2. Navigate the Complex Regulatory Landscape
The Medical Device Act 2012 (Act 737) and its regulations can be complex, with specific requirements for different device types. Bestar's expertise is invaluable for:
Correct Device Classification: We help you accurately classify your device (Class A, B, C, or D), which is the first and most crucial step. A wrong classification can lead to application delays or rejection.
Regulatory Strategy: We develop a tailored market access strategy, leveraging any existing approvals (e.g., CE Mark, FDA approval) to potentially expedite the process through "benchmarking" or "fast-track" routes.
Regulatory Intelligence: We stay up-to-date on the latest regulatory changes, guidance documents, and policies from the MDA, ensuring your submissions and post-market activities remain compliant.
3. Prepare and Submit the Technical Dossier
The registration application requires a comprehensive technical dossier in the ASEAN Common Submission Dossier Template (CSDT) format. This can be a time-consuming and meticulous process. Bestar can assist by:
Gap Analysis: We review your existing technical documentation to identify any gaps or deficiencies that need to be addressed to meet MDA requirements.
Document Compilation: We help compile, organize, and format all necessary documents, including the executive summary, device description, pre-clinical studies, clinical evaluation, risk analysis, and proof of your Quality Management System (QMS).
CSDT Preparation: We have the expertise to prepare a complete and accurate CSDT that meets the MDA's standards, reducing the likelihood of a request for additional information (AI) and shortening the review timeline.
4. Provide Post-Market Compliance Support
Regulatory obligations don't end with device registration. Bestar can also assist with post-market compliance, including:
Post-Market Surveillance: We help you fulfill your obligation to monitor the device's performance after it's on the market.
Adverse Event Reporting: We guide you in fulfilling the mandatory reporting requirements for any adverse events related to your device.
License Maintenance: We manage the re-registration process and handle change notifications (e.g., changes to the manufacturer's name, address, or device design), ensuring your registration remains valid.
GDPMD Certification: We can offer consultancy services to help your local importers and distributors establish a quality management system that meets the requirements of the Good Distribution Practice for Medical Devices (GDPMD) certification.
5. Facilitate Business Operations
Beyond pure regulatory functions, Bestar can offer practical support that gives you more control and flexibility in the market:
Independent License Holding: By using an independent AR (rather than a distributor), you can maintain ownership of your device registration. This gives you the freedom to work with multiple distributors or change distributors without losing market access or leverage.
Expedite Market Entry: Our experience and established relationship with the MDA can help you avoid common pitfalls and delays, leading to a faster and smoother market entry.
In essence, Bestar acts as a vital partner, serving as your "eyes and ears" in the Malaysian market. We not only handle the bureaucratic and technical aspects of registration but also provide strategic guidance that protects your intellectual property and ensures long-term success in the market.
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