The process for registering a Class C medical device in Malaysia involves several key steps to ensure compliance with the Medical Device Authority (MDA) regulations. Here’s a comprehensive guide to the process:

Process for Class C Medical Device Registration in Malaysia

1. Preparation Phase

   • Understand Regulations: Familiarize yourself with the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. Review relevant standards such as ISO 13485 and ISO 14971.
   • Appoint Local Authorized Representative: If you are a non-Malaysian manufacturer, appoint a local Authorized Representative (AR) registered with the MDA.
   • Gather Technical Documentation: Prepare the Common Submission Dossier Template (CSDT), including device description, risk management, clinical evidence, manufacturing information, and labeling.

2. Conformity Assessment

   • Conduct Assessment: Arrange for conformity assessment by a recognized Conformity Assessment Body (CAB). This could include Full Quality Assurance (FQA) audits or Type Examination, depending on the device.
   • Obtain Reports: Ensure you receive and include the required conformity assessment reports with your application.

3. Online Application

   • Create an Account: Register on the MeDC@St system, the MDA’s online portal for medical device registration.
   • Submit Application: Log in to MeDC@St, complete the online application form, and upload all required documentation.
   • Application Form: Accurately fill out the application form with details about the device, manufacturer, and authorized representative.

4. Review and Evaluation

   • Initial Review: The MDA will perform an initial review of your application to ensure completeness and compliance.
   • Additional Information: If the MDA requests additional information or clarifications, provide these promptly to avoid delays.

5. Payment of Fees

   • Fee Structure: Pay the applicable registration fee as per the MDA’s fee schedule. Ensure payment is made through the correct channels as indicated by the MDA.

6. Approval and Issuance

   • Approval: Once the MDA completes its review and is satisfied with the documentation, they will approve the registration.
   • Registration Certificate: Receive the registration certificate from the MDA, which confirms that your device is authorized for sale in Malaysia.

7. Post-Approval Obligations

   • Post-Market Surveillance: Implement a system for monitoring the device’s performance and safety on the market. Report any adverse events to the MDA.
   • Renewal: Keep track of the registration’s expiry date and apply for renewal as needed. Ensure ongoing compliance with regulations and standards.

Step-by-Step Summary

1. Preparation Phase

   • Understand regulations and standards.
   • Appoint a local Authorized Representative (if needed).
   • Prepare technical documentation.

2. Conformity Assessment

   • Conduct and obtain required conformity assessment reports.

3. Online Application

   • Create an account on MeDC@St.
   • Complete and submit the online application form with required documentation.

4. Review and Evaluation

   • MDA reviews the application.
   • Provide additional information if requested.

5. Payment of Fees

   • Pay the registration fee.

6. Approval and Issuance

   • Receive the registration certificate.

7. Post-Approval Obligations

   • Implement post-market surveillance.
   • Apply for renewal before registration expiry.