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

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

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

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

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.

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

Our Medical Device Registration Services

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

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.

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

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.

Required Documents for Registration

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

Common Submission Dossier Template (CSDT)

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

Additional Documentation

Required for devices containing or transmitting radiation, derived from animal tissues, or with Bluetooth and wireless features.

Medical Device Classification in Malaysia

General Medical Devices

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!

Medical Device Registration in Malaysia

Why Register Your IVD Medical Device in Malaysia?

Growing Market

Growing Market

Regulatory Compliance

Regulatory Compliance

Favourable Business Environment

Favourable Business Environment

Medical Tourism Hub

Medical Tourism Hub

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

Our Medical Device Registration Services

Registration Services

Authorised Representative Services

Additional Support Services

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

Options for Foreign Manufacturers

Set Up a Legal Subsidiary

Appoint a Local Importer or Distributor

Appoint an Authorised Representative (AR)

Set Up a Legal Subsidiary

Appoint a Local Importer or Distributor

Appoint an Authorised Representative (AR)

About MeDC@St

Registration Process Overview

Step 1: Classification

Step 2: Submission

Step 3: Evaluation

Step 4: Approval

Step 1: Classification

Step 2: Submission

Step 3: Evaluation

Step 4: Approval

Conformity Assessment and Registration for General and IVD Medical Devices

Class A Devices

Class B, C, and D Devices

Required Documents for Registration

Medical Device Classification in Malaysia

Classification of General Medical Devices:

IVD (In-Vitro Diagnostic) Medical Devices

Classification of IVD Medical Devices

Medical Device Grouping in Malaysia

Typical Fees and Timelines

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!