The process for registering a Class A medical device with the Medical Device Authority (MDA) in Malaysia involves several key steps to ensure that the device complies with the Medical Device Act 2012 (Act 737) and associated regulations. These steps are designed to ensure the safety, effectiveness, and quality of medical devices available in the Malaysian market.

Here’s a detailed outline of the steps for registering a Class A medical device with MDA in Malaysia:

1. Determine Device Classification

• Confirm Classification: The first step is to confirm that the medical device qualifies as a Class A device. Class A devices are typically low-risk devices, such as basic surgical instruments or non-invasive medical devices.
• Classification Process: If you are unsure of the classification, consult the MDA’s classification rules or seek expert advice to confirm that the device is properly categorized under Class A.

2. Designate a Local Authorized Representative (LAR)

• If the Manufacturer is Outside Malaysia: The manufacturer must designate a Local Authorized Representative (LAR) in Malaysia. This is required for manufacturers based outside of Malaysia to handle regulatory submissions, communications, and compliance.
• Responsibilities of LAR: The LAR acts as the liaison between the manufacturer and the MDA, ensuring that the registration process is properly handled and that the device complies with all regulatory requirements.

3. Ensure Compliance with Regulatory Requirements

• ISO 13485 Certification: The manufacturer should ensure that it has an ISO 13485 certification for its quality management system, which is a mandatory requirement for medical device manufacturers.
• Product Documentation: Ensure that the necessary technical documentation for the Class A device is complete, which includes:
  • Product description
  • Intended use
  • Instructions for use (IFU)
  • Risk management report
  • Conformity assessment (if applicable)

4. Register on MeDC@St Portal

• Create an Account: Go to the MeDC@St Portal, the official online registration system for medical devices in Malaysia. Create an account and log in to start the registration process.
• Submit Device Registration: Through the portal, you will be required to submit the device’s information and supporting documents for review.
• Required Documents: Documents to submit include:
  • Device Description and Classification
  • Manufacturer Details
  • Conformity Assessment Documents
  • ISO 13485 Certification
  • Risk Management Report (for device safety)
  • Intended Use and Labeling

5. Submit Registration Application

• Complete Application Form: Fill out the appropriate registration form for a Class A medical device. This includes providing detailed information about the device, the manufacturer, and the intended use.
• Pay Registration Fees: After submitting the application, pay the required registration fees through the MeDC@St portal. Payment is typically required before MDA processes the application.

6. MDA Review and Approval

• MDA Review: Once the application and documents are submitted, MDA will review the information. The review process for Class A medical devices is generally quicker than for higher-risk devices, but MDA may still request additional information or clarification.
• Response to Queries: If MDA raises any queries or requests further documentation, respond promptly with the requested details.
• Approval: If the MDA is satisfied with the submitted information, the device will be approved for registration, and a Certificate of Registration will be issued.

7. Post-Registration Compliance

• Adverse Event Reporting: After registration, the manufacturer must comply with post-market surveillance requirements, including reporting any adverse events or safety concerns to MDA.
• Post-Market Surveillance (PMS): Continue monitoring the performance of the device in the market and submit periodic safety updates if necessary.
• Renewal: Class A medical devices need to be re-registered after five years. Ensure timely submission of documents for renewal.

8. Maintain Compliance

• Quality Management System (QMS): Continuously maintain an ISO 13485 certified quality management system.
• Updates on Device Information: If there are any changes to the device, such as modifications in design, materials, intended use, or labeling, these should be reported to MDA as updates or amendments to the registration.

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

1. Confirm Device Classification: Ensure the device is a Class A device.
2. Designate a Local Authorized Representative (LAR) (for foreign manufacturers).
3. Ensure Regulatory Compliance: Ensure ISO 13485 certification and prepare technical documentation.
4. Register on MeDC@St Portal: Create an account and submit the registration application.
5. Submit Required Documents: Submit device details, documentation, and pay registration fees.
6. MDA Review and Approval: MDA reviews the application, and if all requirements are met, approves the device.
7. Post-Registration Compliance: Monitor the device in the market, report adverse events, and ensure compliance with regulatory updates.
8. Re-registration: Ensure timely renewal after five years.

By following these steps, you can successfully register a Class A medical device with the Medical Device Authority (MDA) in Malaysia and ensure ongoing compliance with regulatory requirements.

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