Medical Device Registration in Malaysia
Malaysia’s thriving healthcare market offers incredible opportunities, but navigating the regulatory process can feel overwhelming. That’s where Andaman Medical steps in.
With our expert guidance in medical device registration in Malaysia, we simplify every step, helping you overcome challenges, avoid delays, and secure a smooth market entry. Whether you’re an emerging manufacturer or an established global company, we handle the complexities for you, so you can focus on delivering innovative medical solutions to patients and healthcare providers.
Why Register Your IVD Medical Device in Malaysia?
Registering your IVD or medical device in Malaysia isn’t just about ticking a regulatory box, it’s about opening doors to a dynamic, fast-growing market with enormous potential.
At Andaman Medical, we provide comprehensive support to help you navigate Malaysia’s regulatory landscape with ease. From ensuring a smooth registration process to ongoing compliance, we’re your trusted partner every step of the way.
Here’s why Malaysia is the perfect destination for your medical device registration:
Growing Market
Growing Market
Malaysia’s medical device market is rapidly expanding, driven by demand for advanced healthcare solutions and access to a diverse patient population. We assist your market entry by navigating regulations, identifying opportunities, and ensuring a smooth compliance process.
Regulatory Compliance
Regulatory Compliance
Malaysia’s regulatory framework, overseen by the Medical Device Authority (MDA), ensures that only safe and effective IVD devices enter the market. We ensure regulatory compliance by managing product registrations, facilitating audits, and acting as your Local Authorized Representative for seamless market access.
Favourable Business Environment
Favourable Business Environment
Malaysia’s business-friendly environment, strong infrastructure, and skilled workforce make it an attractive destination for medical device companies. We help you leverage Malaysia’s business-friendly environment by providing regulatory guidance, market insights, and logistical support for a smooth setup.
Medical Tourism Hub
Medical Tourism Hub
As a leading medical tourism destination, Malaysia sees a high demand for quality medical devices, attracting international patients seeking advanced diagnostic solutions. We ensure your devices meet the needs of healthcare providers serving patients while maintaining compliance in this lucrative market.
Our Medical Device Registration Services
Authorised Representative Services
- Liaison with the local government agency on all regulatory issues, including amendments and change notifications
- Regulatory monitoring to alert you to any changes or new regulations applicable to your product
- Licence holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
What You Need to Know About Medical Device Registration in Malaysia?
Options for Foreign Manufacturers
Set Up a Legal Subsidiary
Full Control: Foreign manufacturers can establish a wholly-owned subsidiary in Malaysia to register and market their medical devices directly. This option provides greater control over market operations but requires significant investment and resources.
Appoint a Local Importer or Distributor
Choose a local partner with a valid establishment licence, GDPMD certification, and a registered account on MeDC@St. This partner can manage the importation and distribution of your medical devices.
Appoint an Authorised Representative (AR)
- Common Approach: Foreign manufacturers often appoint a local company as their Authorised Representative (AR) to manage the registration process.
- AR Responsibilities: The AR acts as the legal representative in Malaysia, communicates with the Medical Device Authority (MDA), and ensures compliance with local regulations.
- For example, Andaman Medical can register and maintain your medical device licence, offering flexibility in choosing importers or distributors.

Set Up a Legal Subsidiary
Full Control: Foreign manufacturers can establish a wholly-owned subsidiary in Malaysia to register and market their medical devices directly. This option provides greater control over market operations but requires significant investment and resources.

Appoint a Local Importer or Distributor
Choose a local partner with a valid establishment licence, GDPMD certification, and a registered account on MeDC@St. This partner can manage the importation and distribution of your medical devices.

Appoint an Authorised Representative (AR)
- Common Approach: Foreign manufacturers often appoint a local company as their Authorised Representative (AR) to manage the registration process.
- AR Responsibilities: The AR acts as the legal representative in Malaysia, communicates with the Medical Device Authority (MDA), and ensures compliance with local regulations.
- For example, Andaman Medical can register and maintain your medical device licence, offering flexibility in choosing importers or distributors.
About MeDC@St
Registration Process Overview
Here’s a step-by-step overview to help navigate process for medical device registration in Malaysia:
Step 1: Classification
IVD devices in Malaysia are classified into four classes based on risk level:
- Class A: Low Risk
- Class B: Low-Moderate Risk
- Class C: High-Moderate Risk
- Class D: High Risk
Step 2: Submission
Once classified, devices in Classes B, C, and D must undergo a conformity assessment by a registered Conformity Assessment Body (CAB). If conformity is confirmed, the registration application is submitted through the Medical Device Centralized Online Application System (MeDC@St2.0+). The application must include comprehensive documentation as per the Common Submission Dossier Template (CSDT), except for Class A devices.
Step 3: Evaluation
The Medical Device Authority (MDA) evaluates the application to ensure compliance with the Medical Device Act 2012 (Act 737) and that the device meets all safety and performance requirements.
Step 4: Approval
Upon successful evaluation, the MDA grants approval, allowing the IVD device to be legally imported, exported, and marketed in Malaysia.
Step 1: Classification
IVD devices in Malaysia are classified into four classes based on risk level:
- Class A: Low Risk
- Class B: Low-Moderate Risk
- Class C: High-Moderate Risk
- Class D: High Risk
Step 2: Submission
Once classified, devices in Classes B, C, and D must undergo a conformity assessment by a registered Conformity Assessment Body (CAB). If conformity is confirmed, the registration application is submitted through the Medical Device Centralized Online Application System (MeDC@St2.0+). The application must include comprehensive documentation as per the Common Submission Dossier Template (CSDT), except for Class A devices.
Step 3: Evaluation
The Medical Device Authority (MDA) evaluates the application to ensure compliance with the Medical Device Act 2012 (Act 737) and that the device meets all safety and performance requirements.
Step 4: Approval
Upon successful evaluation, the MDA grants approval, allowing the IVD device to be legally imported, exported, and marketed in Malaysia.
Conformity Assessment and Registration for General and IVD Medical Devices
Class A Devices
Exempt from conformity assessment. They can directly submit registration via MeDC@St.
Class B, C, and D Devices
- If approved in recognized countries (USA, EU, Canada, Australia, UK, Japan), they follow a simplified, accelerated process.
- If not approved in these countries, a full conformity assessment by a registered CAB is required.
- After receiving CAB approval, Class B, C, and D devices can submit their registration application via MeDC@St2.0+.
Required Documents for Registration
- Executive summary
- Device description
- Pre-clinical studies
- Clinical evaluation
- Device labelling
- Instructions for use
- Risk analysis
- Proof of quality management system
- Manufacturing information
- Essential principles checklist
- Declaration of conformity
- Existing regulatory approvals or market authorizations
- Required for devices containing or transmitting radiation, derived from animal tissues, or with Bluetooth and wireless features.
Medical Device Classification in Malaysia
Medical devices in Malaysia are classified based on the risk they pose at the point of use. Key factors that influence classification include:
- Intended purpose
- Risk management effectiveness
- Intended user(s)
- Mode of operation
- Technology used
- Duration of body contact
- Degree and site of invasiveness
- Delivery of medicine or energy
- Biological effect on the body
- Intended action on the human body
- Local vs. systemic effects
- Contact with injured skin
- Diagnosis or treatment purpose
- Reusability
- Combination of devices
Classification of General Medical Devices:
Class | Risk Level | Device Examples |
---|---|---|
A | Low | Simple surgical instruments, tongue depressors, stethoscopes |
B | Low-Moderate | Hypodermic needles, hearing aids, x-ray films |
C | High-Moderate | Lung ventilators, orthopaedic implants, defibrillators |
D | High | Pacemakers, implantable defibrillators, heart valves |
IVD (In-Vitro Diagnostic) Medical Devices
- Intended use
- Expertise of the intended user (layperson or healthcare professional)
- Importance of information to diagnosis
- Impact of results on individuals and public health
Classification of IVD Medical Devices
Class | Risk Level | Device Examples |
---|---|---|
A | Low | Clinical chemistry analyser, prepared selective culture media |
B | Low-Moderate | Vitamin B12, pregnancy self-testing, urine test strips |
C | High-Moderate | Blood glucose self-testing, rubella |
D | High | HIV blood donor screening, HIV blood diagnostic |
Medical Device Grouping in Malaysia
- Single
- Family
- Family of System
- System
- Set
- IVD Test Kit
- IVD Cluster
- Same generic proprietary name
- Same manufacturer
- Common intended use
Typical Fees and Timelines
Class | Application Fee (RM) | Registration Fee (RM) | Turn-Around Time (Working Days) |
---|---|---|---|
A | 100 | Not Applicable | 30 |
B | 250 | 1,000 | 60 |
C | 500 | 2,000 | 60 |
D | 750 | 3,000 | 60 |
- Application Fee: Required for all device classes upon submission.
- Registration Fee: Charged upon approval for issuing the formal registration certificate. Class A devices are exempt from this fee.