Class A medical device registration with the Medical Device Authority (MDA) in Malaysia is the regulatory process required to legally market and distribute low-risk medical devices in Malaysia. Class A devices, considered the lowest risk category under Malaysia’s Medical Device Act 2012, include items such as bandages, non-sterile surgical instruments, and basic diagnostic equipment. The registration ensures these devices meet the standards for quality, safety, and efficacy.

Overview of Class A Medical Device Registration in Malaysia

• Regulatory Body: Medical Device Authority (MDA), Malaysia.
• Governing Law: Medical Device Act 2012 and Medical Device Regulations 2012.
• Scope: All Class A medical devices, including imports, must be registered to be sold legally in Malaysia.
• Risk Class: Class A is categorized as low-risk devices.

Steps to Apply for Class A Medical Device Registration in Malaysia

1. Classify the Device

   • Verify the device classification to confirm it is Class A under the Malaysian Medical Device Regulations.

2. Appoint a Local Authorized Representative (AR)

   • For foreign manufacturers, an Authorized Representative (AR) must be appointed. This AR must be licensed and registered with the MDA to submit applications on behalf of foreign manufacturers.

3. Prepare Required Documentation

   • ISO 13485 Certification: Ensure the manufacturing facility is ISO 13485 certified, demonstrating that it meets quality management standards for medical devices.
   • Technical File: Prepare a comprehensive technical file that includes the device’s design, intended use, labeling, instructions for use, and safety data.
   • Declaration of Conformity: For Class A devices, a declaration of conformity signed by the manufacturer or AR is typically sufficient as a self-declaration of compliance.

4. Register and Submit the Application on MeDC@St

   • Sign up on Malaysia’s Medical Device Centralized Online Application System (MeDC@St).
   • Submit the completed technical documentation, ISO 13485 certificate, and the declaration of conformity through this online portal.
   • Pay the registration fees, which may vary depending on the type of application and device.

5. MDA Review and Approval

   • The MDA will conduct an assessment of the application, focusing on compliance with the Medical Device Act and ensuring safety and performance standards are met.
   • For Class A devices, the review process is generally less stringent and faster than for higher-risk classes, given the low-risk profile of these devices.

6. Post-Approval Compliance

   • Once approved, the device receives a registration certificate. The registration is valid for five years, after which it must be renewed.
   • Continue to comply with post-market surveillance requirements, including adverse event reporting and quality control.

Summary of Requirements:

• ISO 13485 Certification for quality management.
• Technical File with all necessary safety, design, and usage documentation.
• Declaration of Conformity by the manufacturer or AR.
• Submission and Fees paid through the MeDC@St platform.

This process enables regulatory oversight for Class A medical devices, ensuring only safe, quality-assured devices reach the Malaysian market.