To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, the following steps should be followed. This process ensures that the medical device complies with the Medical Device Act 2012 (Act 737) and associated regulations.

Step-by-Step Guide to Registering a Class A Medical Device with MDA in Malaysia

Step 1: Determine the Device Classification

• Confirm Classification: Before initiating the registration process, ensure that your device is classified as Class A. This is typically a low-risk device, such as basic surgical instruments or non-invasive medical devices.
• Check MDA Classification Rules: Refer to the MDA classification rules if you are unsure of the device’s classification, or consult with regulatory experts to ensure correct classification.

Step 2: Assign a Local Authorized Representative (LAR)

• For Foreign Manufacturers: If the manufacturer is located outside Malaysia, they must designate a Local Authorized Representative (LAR) in Malaysia. The LAR is the entity that will act as the liaison between the manufacturer and MDA, and will be responsible for handling the regulatory submission process.
• LAR Responsibilities: The LAR will submit the application and ensure that all regulatory requirements are met.

Step 3: Ensure Compliance with Regulatory Requirements

• ISO 13485 Certification: Ensure the manufacturer holds ISO 13485 certification for its quality management system, as this is a requirement for registering a medical device in Malaysia.
• Prepare Documentation: Ensure all required documentation is ready for submission. This includes:
  • Product description: Detailed information about the device.
  • Intended use: Clear indication of how the device is to be used.
  • Instructions for Use (IFU): User manual and device instructions.
  • Risk management report: A report addressing the device’s risk analysis, which must comply with ISO 14971.
  • Conformity assessment documentation (if applicable): For example, a CE mark or evidence of compliance with international standards.

Step 4: Register on the MeDC@St Portal

• Access the MeDC@St Portal: The MeDC@St Portal is the official platform for submitting medical device registration applications in Malaysia.
  • Visit the MeDC@St Portal and create an account if you haven’t already done so.
• Submit the Registration Application: Once your account is active, log in and fill out the required registration form for a Class A medical device. The form will require details such as:
  • Device name and description
  • Manufacturer details
  • Device classification and intended use
  • ISO 13485 certification
  • Risk management report
  • Labeling and IFU details

Step 5: Pay Registration Fees

• Registration Fees: After submitting the application form and required documents, you will be asked to pay the registration fees. The fees vary depending on the type and classification of the device.
  • Payment can be made directly through the MeDC@St portal using available payment methods.

Step 6: MDA Review of Application

• Initial Document Check: Once the application is submitted, MDA will conduct an initial document completeness check to ensure that all required documents are provided and that they meet the necessary standards.

• Technical Review: After the document check, the MDA will conduct a technical review of the device’s documentation to ensure compliance with:

  • Risk management standards (e.g., ISO 14971)
  • Safety and performance requirements
  • Labeling and packaging requirements
  • ISO 13485 certification

• Response to Queries: If MDA has any questions or needs additional information, they will issue a query to the applicant. The applicant must respond to these queries promptly to avoid delays in the approval process.

Step 7: Approval and Issuance of Certificate

• Approval Decision: If the review process is successful and all requirements are met, MDA will approve the device for registration.

• Certificate of Registration: Upon approval, the Certificate of Registration will be issued by MDA. This confirms that the device is officially registered and authorized for sale and distribution in Malaysia.

Step 8: Post-Registration Requirements

• Adverse Event Reporting: After registration, manufacturers are required to report any adverse events, malfunctions, or safety issues related to the device to MDA.

• Post-Market Surveillance (PMS): Manufacturers must maintain a system to monitor the safety and performance of the device in the market and report any necessary updates to MDA.

• Re-registration: Class A medical devices need to be re-registered every five years to ensure continued compliance with MDA regulations.

Summary of Steps to Register a Class A Medical Device with MDA:

1. Confirm Device Classification: Ensure the device is a Class A medical device.
2. Designate a Local Authorized Representative (LAR) (if the manufacturer is outside Malaysia).
3. Ensure Compliance: Verify ISO 13485 certification and prepare all necessary documentation.
4. Register on MeDC@St Portal: Create an account and submit the registration application.
5. Pay Registration Fees: Complete the payment for the application.
6. MDA Review: MDA reviews the application and documents.
7. Approval: MDA issues a Certificate of Registration if the application meets requirements.
8. Post-Registration Compliance: Monitor the device post-market, report adverse events, and ensure re-registration after five years.

By following these steps, you can successfully navigate the MDA registration process for a Class A medical device in Malaysia and ensure the device is compliant with local regulations.

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