IVD Medical Device Registration in Malaysia
Our experienced regulatory affairs specialists provide comprehensive support, from initial classification and submission to post-market compliance, ensuring your IVD devices meet all regulatory requirements for successful market entry.
Why Register Your IVD Medical Device in Malaysia?
Growing Market
Growing Market
Malaysia’s medical device market is expanding rapidly, driven by an increasing demand for advanced healthcare solutions. As a key player in Southeast Asia, Malaysia provides access to a large and diverse patient population.
Regulatory Compliance
Regulatory Compliance
Malaysia’s regulatory framework for medical devices, overseen by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH), ensures that only safe and effective devices enter the market. Compliance with these stringent regulations enhances the credibility and acceptance of your IVD device both locally and in other markets.
Favorable Business Environment
Favorable Business Environment
Malaysia offers a business-friendly environment with various incentives for foreign manufacturers. The country’s robust infrastructure, skilled workforce, and supportive government policies make it an attractive destination for medical device companies.
Medical Tourism Hub
Medical Tourism Hub
Malaysia is recognized globally as a leading medical tourism destination. This status not only boosts the demand for high-quality medical devices but also ensures a steady influx of international patients seeking advanced diagnostic solutions.
Our IVD Medical Device Registration Services
Regulatory Strategy
Tailored regulatory strategies to optimise the registration process for your IVD device.
Dossier Preparation
Compiling and reviewing all necessary documentation in compliance with Medical Device Authority (MDA).
Submission Management
Handling the entire submission process, including communications with MDA.
Post-Market Compliance
Assist in adverse event reporting, change notifications and more.
Registration Process Overview
Step 1: Classification
In Malaysia, IVD devices are classified into four classes based on the risk level associated with the device based on several factors specified by the MDA:
- Class A: Low Risk
- Class B: Low-Moderate Risk
- Class C: High-Moderate Risk
- Class D: High Risk
Step 2: Submission
Once the classification is determined, the conformity assessment is done by a registered Conformity Assessment Body (CAB) eligible for Class B, C, and D IVD.
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The CAB decides to grant certification if there is sufficient evidence of conformity.
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Submit the registration application through the Medical Device Centralized Online Application System (MeDC@St2.0+), provided by the MDA.
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The application must include comprehensive documentation as per the Common Submission Dossier Template (CSDT), except for Class A IVDs.
Step 3: Evaluation
The MDA conducts a thorough evaluation of the application to ensure that the device complies with the Medical Device Act 2012 (Act 737) and meets all safety and performance requirements.
Step 4: Approval
After successful evaluation, the MDA grants approval for the IVD device registration. Once approved, the device can be legally imported, exported, and marketed in Malaysia.
Step 1: Classification
In Malaysia, IVD devices are classified into four classes based on the risk level associated with the device based on several factors specified by the MDA:
- Class A: Low Risk
- Class B: Low-Moderate Risk
- Class C: High-Moderate Risk
- Class D: High Risk
Step 2: Submission
Once the classification is determined, the conformity assessment is done by a registered Conformity Assessment Body (CAB) eligible for Class B, C, and D IVD.
↓
The CAB decides to grant certification if there is sufficient evidence of conformity.
↓
Submit the registration application through the Medical Device Centralized Online Application System (MeDC@St2.0+), provided by the MDA.
↓
The application must include comprehensive documentation as per the Common Submission Dossier Template (CSDT), except for Class A IVDs.
Step 3: Evaluation
The MDA conducts a thorough evaluation of the application to ensure that the device complies with the Medical Device Act 2012 (Act 737) and meets all safety and performance requirements.
Step 4: Approval
After successful evaluation, the MDA grants approval for the IVD device registration. Once approved, the device can be legally imported, exported, and marketed in Malaysia.
IVD Registration Timeline and Fees
| Class | Application Fee Payable (RM) | Registration Fee Payable (RM) | Turn-Around Time (Working Days) |
|---|---|---|---|
| Class A | 100 | Not Applicable | 30 |
| Class B | 250 | 1000 | 100 |
| Class C | 500 | 2000 | 180 |
| Class D | 750 | 3000 | 220 |
