To apply for the Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, you must follow a series of procedures to ensure that the device meets the regulatory standards under the Medical Device Act 2012 (Act 737). Below are the detailed steps for applying for the registration of a Class A medical device with MDA in Malaysia:

Step-by-Step Procedures for Class A Medical Device MDA Registration

1. Determine Device Classification

• Ensure Class A Classification: Confirm that your device qualifies as a Class A medical device. Class A devices are generally considered low-risk devices, such as simple surgical instruments or non-invasive medical devices.
• Check Classification Rules: If unsure about the classification, refer to the MDA's Classification Guidelines or seek guidance from regulatory experts to confirm the appropriate classification.

2. Designate a Local Authorized Representative (LAR)

• For Foreign Manufacturers: If the manufacturer is based outside Malaysia, they must designate a Local Authorized Representative (LAR) in Malaysia. The LAR acts as the official liaison between the manufacturer and MDA for all regulatory matters.
• LAR Responsibilities: The LAR is responsible for submitting the registration application, handling communications with MDA, and ensuring that all regulatory requirements are met.

3. Prepare the Required Documentation

• Ensure Compliance with Regulatory Requirements: Before applying, make sure the device meets the necessary regulatory requirements for registration. This includes:
  • ISO 13485 Certification: The manufacturer must have a valid ISO 13485 certification for the quality management system, which is mandatory for all medical device manufacturers.
  • Device Information: Prepare a detailed description of the device, its intended use, and classification.
  • Instructions for Use (IFU): Provide clear instructions for the proper use of the device.
  • Risk Management Report: A risk assessment report that meets ISO 14971 standards must be included to demonstrate that the device is safe for use.
  • Conformity Assessment: If applicable, provide a CE Marking or other certifications that demonstrate compliance with international standards.
  • Device Labeling: Ensure that the device’s labeling complies with MDA regulations.

4. Register on the MeDC@St Portal

• Access the Portal: The registration application for medical devices must be submitted via the MeDC@St Portal, which is the official online platform for medical device registration in Malaysia.
  • Create an Account: If you do not already have an account, go to the MeDC@St Portal and create one. If you are the Local Authorized Representative, you can create an account on behalf of the manufacturer.
• Log In: After account creation, log in to access the application system.

5. Submit the Registration Application

• Complete the Registration Form: In the MeDC@St portal, complete the registration application form. The form will require:
  • Device name and model
  • Manufacturer details
  • Classification and intended use
  • ISO 13485 certification
  • Risk management report
  • Labeling, including instructions for use
• Attach Documents: Upload the necessary documents (e.g., ISO 13485 certificate, risk management report, labeling, etc.) as per MDA requirements.

6. Pay Registration Fees

• Payment: After submitting the registration application, you will be required to pay the registration fees. Payment can be made directly via the MeDC@St Portal.
• Fee Structure: The fee amount varies based on the device type and classification. For Class A devices, the fees tend to be lower compared to higher-risk devices.

7. MDA Review of Application

• Document Completeness Check: MDA will first check if the submitted application is complete and that all required documents are included.
• Technical Review: MDA will conduct a detailed technical review of the device’s documentation. This includes:
  • Risk management compliance (ISO 14971)
  • Conformity with international standards (ISO 13485, ISO 10993 for biocompatibility if applicable)
  • Device safety and performance evaluation
  • Labeling and IFU compliance with MDA standards
• Additional Information: If MDA requires further information or clarifications, they will issue queries to the manufacturer or Local Authorized Representative. These queries must be addressed promptly to avoid delays.

8. Issuance of Certificate of Registration

• Approval: If the MDA finds that the device complies with all regulatory requirements, it will approve the registration application.
• Certificate of Registration: After approval, MDA will issue a Certificate of Registration, confirming that the Class A medical device is registered and authorized for sale and distribution in Malaysia.

9. Post-Registration Compliance

• Post-Market Surveillance: Once registered, the manufacturer must adhere to post-market surveillance obligations, including reporting any adverse events or safety issues related to the device.
• Re-Registration: Class A medical devices need to be re-registered every five years to maintain their registration status.

Summary of Procedures for Class A Medical Device MDA Registration

1. Determine Device Classification: Ensure the device is a Class A medical device.
2. Designate a Local Authorized Representative (LAR) (for foreign manufacturers).
3. Prepare Documentation: Ensure compliance with ISO 13485, prepare device information, labeling, risk management report, and other required documents.
4. Register on MeDC@St Portal: Create an account and submit the registration application online.
5. Pay Fees: Complete the payment for the registration application.
6. MDA Review: MDA reviews the application for completeness, technical compliance, and safety.
7. Approval & Registration: If the device complies with MDA’s requirements, the Certificate of Registration is issued.
8. Post-Registration Compliance: Follow post-market surveillance requirements and ensure re-registration every five years.

By following these procedures, you can successfully apply for the registration of a Class A medical device with the MDA in Malaysia.

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