To apply for Class B medical device registration in Malaysia, certain conditions must be met to ensure compliance with the regulations set by the Medical Device Authority (MDA). Here are the key conditions:

1. Device Classification:

• Confirm that the device is accurately classified as Class B according to MDA guidelines. Class B devices are considered moderate-risk.

2. Compliance with Regulatory Requirements:

• Ensure that the device meets all relevant regulatory standards and requirements as specified by the MDA.

3. Manufacturer Eligibility:

• The manufacturer must be registered and have a valid address, whether located in Malaysia or internationally. If the manufacturer is overseas, they may need to appoint a local authorized representative.

4. Quality Management System (QMS):

• The manufacturer must demonstrate compliance with a recognized QMS standard, such as ISO 13485. This includes having documented procedures for design, manufacturing, and quality control.

5. Complete Documentation:

• Prepare a comprehensive technical file, which includes:
  • Detailed device description and intended use.
  • Design and manufacturing specifications.
  • Risk management documentation (ISO 14971).
  • Clinical evaluation data supporting the safety and effectiveness of the device.
  • Labeling and instructions for use.

6. Submission through MeDC@St:

• Applications must be submitted through the MDA’s online portal, MeDC@St. A registered account on this platform is required.

7. Payment of Fees:

• The appropriate registration fees must be paid at the time of application submission.

8. Post-Market Surveillance Plan:

• Have a plan for post-market surveillance, including how to monitor the device’s performance and manage any adverse events after it is marketed.

Important Considerations:

• Consult MDA Guidelines: Regularly review the MDA's official guidelines for updates on requirements or conditions that may affect your application.
• Seek Expert Guidance: If you're unsure about any aspect of the registration process, consider consulting with regulatory professionals who have experience in the Malaysian market.

Meeting these conditions will help ensure a smoother application process for Class B medical device registration in Malaysia.

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