What is Class C Medical Device Registration in Malaysia?

In Malaysia, medical devices are classified into four risk categories: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk).

Class C medical devices are considered medium to high-risk devices that may have significant impact on the health and safety of patients. These devices generally support or sustain human life, and any malfunction or incorrect use could pose a higher level of risk compared to Class A or B devices. Examples of Class C devices include dialysis machines, diagnostic imaging equipment, and certain surgical instruments.

The Medical Device Authority (MDA) under Malaysia’s Ministry of Health regulates the registration of all medical devices in the country. The registration ensures that the devices meet the required safety, efficacy, and performance standards before being introduced to the Malaysian market.

How to Apply for Class C Medical Device Registration in Malaysia

Here’s a detailed process for applying for the registration of a Class C medical device:

1. Classification of the Medical Device

• Before applying, confirm that your device falls under Class C. Device classification is based on the intended purpose and level of risk, which can be verified through the Medical Device Regulations 2012 or using the classification rules in the MDA guidelines.

2. Appoint an Authorized Representative (AR)

• If the manufacturer is not based in Malaysia, an Authorized Representative (AR) must be appointed to act on behalf of the manufacturer. The AR is responsible for the application process and communication with the MDA.
• The AR should be registered with the MDA.

3. Prepare the Common Submission Dossier Template (CSDT)

The CSDT is a structured document used to present the technical and safety information of the medical device. The key components of the CSDT include:

• Device description and specifications: Detailed information on the device and its intended use.
• Risk management: Risk analysis and risk control measures to ensure the safety of the device.
• Essential principles: Demonstration of how the device complies with the essential principles of safety and performance.
• Clinical evidence: Clinical data supporting the safety and efficacy of the device.
• Manufacturing information: Details about the manufacturing process and facilities.
• Labeling and instructions for use: Packaging, labeling, and instructions to ensure safe usage.

4. Conduct a Conformity Assessment

• A Conformity Assessment must be completed to demonstrate that the device meets the applicable safety and performance standards.
• The Conformity Assessment can be conducted by a recognized Conformity Assessment Body (CAB), which assesses the technical documentation and verifies the compliance with Malaysian regulations.
• For Class C devices, this may require:
  • A Full Quality Assurance (FQA) audit or
  • A Type Examination of the product.

5. Register the Device via the MeDC@St System

• You will need to register the device using the Medical Device Centralized Online Application System (MeDC@St).
• You must create an account in the system, submit the necessary documents (CSDT, Conformity Assessment report, and manufacturer’s declaration of conformity), and pay the relevant fees.
• The fee structure varies depending on the classification of the device.

6. Application Review by the MDA

• The MDA will review your application and the submitted documents to ensure compliance with Malaysian regulatory standards.
• This process can take several months for Class C devices due to the complexity of the review process and the higher risk classification.

7. Approval and Post-Market Obligations

• Once approved, you will receive a registration certificate that allows the device to be sold in Malaysia.
• The registration is valid for 5 years, after which it must be renewed.
• Post-market surveillance is required for Class C devices. You must monitor the performance of the device in the market and report any adverse events, malfunctions, or recalls to the MDA.

Required Documents for Class C Medical Device Registration:

• Common Submission Dossier Template (CSDT)
• Manufacturer’s Declaration of Conformity
• Quality management system certification (e.g., ISO 13485)
• Conformity Assessment Report from a Conformity Assessment Body (CAB)
• Appointment letter for the Authorized Representative (if applicable)
• Device labeling and packaging information
• Proof of payment of the registration fees

Useful Resources:

• Medical Device Authority (MDA)
• MeDC@St system
• Medical Device Act 2012 (Act 737)

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