To apply for the registration of Class B medical devices in Malaysia, follow these steps and use the specified platforms:

1. Prepare Required Documentation

Before applying, ensure you have the necessary documents ready, including:

• Device Description: Detailed specifications, intended use, and technical information.
• Clinical Evidence: Data supporting the safety and efficacy of the device.
• Labeling and Packaging: Labels, packaging details, and instructions for use.
• Risk Management: Documentation of risk analysis and management.
• Quality Management System (QMS): Proof of compliance with QMS standards (e.g., ISO 13485).
• Manufacturer Information: Details about the manufacturer and manufacturing processes.
• Local Authorized Representative (LAR): If applicable, appoint a local representative and provide their details.

2. Create an Account on MeDC@St

• MeDC@St System: This is the Medical Device Centralised Online Application System managed by the Medical Device Authority (MDA).

• Access: Visit the MeDC@St portal on the MDA’s website. You will need to create an account or log in if you already have one.

3. Complete the Application Form

• Online Submission: Fill out the registration application form specific to Class B medical devices on the MeDC@St system. Ensure all required fields are accurately completed.

• Document Upload: Upload all necessary documentation as specified in the application guidelines.

4. Pay the Registration Fee

• Fee Payment: Pay the applicable registration fee. Details of the fee structure can be found on the MDA’s website. Payment instructions will be provided on the MeDC@St system.

5. Submit the Application

• Review and Submit: Review all submitted information for completeness and accuracy. Submit the application through the MeDC@St system.

6. Monitor Application Status

• Tracking: Use the MeDC@St system to track the status of your application. Monitor for any requests for additional information or clarification from MDA.

7. Respond to Queries

• Additional Information: Be prepared to provide additional information or clarification if requested by MDA during their review process.

8. Receive Approval

• Registration Certificate: Once your application is approved, you will receive a registration certificate allowing you to market and distribute the device in Malaysia.

Contact and Support

• Medical Device Authority (MDA):
  • Website: MDA Official Website
  • Phone: Contact details are available on the MDA website.
  • Email: Relevant email addresses for inquiries can be found on the MDA website.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn