To register a Class A (low-risk) medical device with the Medical Device Authority (MDA) in Malaysia, you must go through the following steps:

1. Confirm Product Classification

• Verify that your product qualifies as a Class A device according to Malaysia's Medical Device Regulation 2012. Class A devices are typically low-risk devices (e.g., surgical instruments, bandages, thermometers).

2. Appoint a Local Authorized Representative (if applicable)

• For foreign manufacturers, appoint a licensed local authorized representative (AR) to handle registration and act as a liaison with the MDA.

3. Prepare Documentation and Obtain ISO 13485 Certification

• Ensure your manufacturing process complies with ISO 13485 (Quality Management Systems for Medical Devices). This certification is mandatory for medical device registration in Malaysia.
• Prepare a comprehensive technical file with documentation on your device's safety, efficacy, design, labeling, and intended use.

4. Complete Conformity Assessment

• Undergo a conformity assessment for Class A devices. This process ensures compliance with Malaysian safety and performance standards, although it is less stringent than for higher-risk classes.
• Self-declaration by the manufacturer or AR can often suffice for Class A devices, but the declaration must confirm compliance with regulatory requirements.

5. Submit an Application through MeDC@St (Medical Device Centralized Online Application System)

• Register an account in the MDA’s online platform, MeDC@St.
• Submit the device’s technical file, ISO 13485 certificate, and declaration of conformity.
• Pay the applicable registration fee for Class A devices.

6. Await Review and Approval

• The MDA will review your application. For Class A devices, the process is typically quicker and may not involve as detailed scrutiny as for higher-risk devices.
• Once approved, you will receive a registration certificate allowing you to market the device in Malaysia.

7. Post-Registration Compliance

• Maintain compliance with Malaysia's regulations and submit post-market reports as required.
• Renew the device registration every five years to ensure continuous market access.

Key Points:

• Make sure to stay updated with any changes in MDA regulations, as requirements can evolve.
• Accurate documentation and adherence to quality standards are crucial for a smooth approval process.

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