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:

Why Choose Andaman Medical as Your Medical Device Registration Consultant in Malaysia?

Our Medical Device Registration Services

Registration Services

  • Standard product registration
  • Special access product registration
  • Renewal of product registration
  • Amendment and change notification
  • Product licence withdrawal

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

Additional Support Services

  • Regulatory intelligence reports providing insights into market access routes and the latest regulatory landscape in your target market
  • Importation
  • Storage and warehousing
  • Relabeling
  • Online regulatory training

What You Need to Know About Medical Device Registration in Malaysia?

Only companies registered with the Companies Commission of Malaysia (SSM) can apply for an establishment licence and register a medical device in Malaysia. These companies must create an account on the MeDC@St2.0+ system and apply for the appropriate Establishment Licence: Manufacturer, Importer, Distributor, or Authorised Representative.

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

MeDC@St is a web-based system used for Establishment Licensing, Medical Device Registration, and Export Permit applications. It was upgraded to MeDC@St2.0 in 2019 and further enhanced to MeDC@St2.0+ in 2022, introducing new features for a better user experience. Applicants need only create one account to manage all licensing and registration needs through this centralised platform.

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

To register a medical device in Malaysia, it must first undergo a conformity assessment by a Conformity Assessment Body (CAB) accredited by the Medical Device Authority (MDA). This assessment ensures the device complies with the Essential Principles of Safety and Performance for 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

The following documents are required for medical device registration in Malaysia (all must be in English):
  • 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

IVD devices are classified based on:

  • 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

Under the Medical Device Act 2012, manufacturers or authorised representatives must register medical devices before importing, exporting, or marketing them in Malaysia. Medical devices can be grouped as follows:
 
  • Single
  • Family
    • Family of System
  • System
  • Set
For IVD medical devices, additional groupings include:

  • IVD Test Kit
  • IVD Cluster
Grouping Conditions:

  • 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
Upon submitting a medical device registration application, the MDA imposes an application fee for all device classes. The evaluation process begins only after this fee is paid.

  • 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.
All payments through the MeDC@St2.0+ system must be made within 60 days from the invoice date. If payment is not made within this period, the application will be automatically dropped, and a new application must be submitted.
Navigating medical device registration in Malaysia can be complex, but Andaman Medical is here to simplify the process and ensure you stay fully compliant. Connect with our experts today and take the first step toward smooth registration!
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