After applying for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia, several rules and requirements must be adhered to during the process and after the submission. These regulations ensure that the device meets all necessary safety, performance, and compliance standards for market entry. Here are the key rules and requirements to follow after applying for the registration of a Class A medical device:

1. Submission of Required Documents

• Ensure Complete and Accurate Documentation: After submission, ensure that all required documents are included in the application. If MDA requests additional documents or clarification, you must respond promptly and provide the requested information.
• Maintain Document Integrity: Make sure that all submitted documents (e.g., technical files, risk management reports, and labeling) are accurate, up-to-date, and comply with MDA guidelines. Any discrepancies can delay the registration process.

2. Adherence to MDA’s Application Process

• MDA’s Review Timeline: Once the application is submitted, MDA will begin the review process. Class A medical devices usually have a quicker review period due to their low-risk nature, but this still depends on the completeness of the application. Ensure that you track the progress through the MeDC@St portal.
• Response to Queries: If MDA sends queries or requests additional information during the review process, you are required to provide responses within the specified timeline. Failure to do so could result in delays or rejection of the application.

3. Payment of Registration Fees

• Pay Registration Fees: After the application is processed and if it is approved, you will be required to pay the registration fees. The payment details will be provided through the MeDC@St portal.
• Fee Payment Deadline: Ensure the registration fee is paid by the specified deadline to avoid delays in final approval.

4. Post-Market Surveillance Requirements

• Post-Market Surveillance (PMS): Once the device is registered, MDA requires continuous post-market surveillance. This includes monitoring the device’s performance and safety once it is on the market. Be prepared to report any adverse events or safety concerns related to the device to MDA.
• Adverse Event Reporting: If there are any issues with the device after it is marketed, such as safety incidents or malfunctions, you must report these incidents to MDA within the prescribed timeline. This may involve submitting a Corrective and Preventive Action (CAPA) plan.
• Periodic Safety Updates: Depending on the type of device, you may be required to submit periodic safety reports or updates based on post-market data. These reports might include information about the device’s usage, any adverse events, or changes in risk management.

5. Compliance with Labeling Requirements

• Ensure Accurate Labeling: The device's labeling must continue to comply with MDA’s labeling requirements, including accurate product information in Bahasa Malaysia and/or English. This includes clear indications of the intended use, safety warnings, and usage instructions.
• Changes to Labeling: If there are any changes to the labeling after registration (e.g., new warnings, updated instructions), you must inform MDA and obtain approval if necessary before distributing the updated device.

6. Quality Management System (QMS) Maintenance

• Maintain ISO 13485 Certification: The manufacturer must maintain its ISO 13485 certification for quality management systems. This involves regular audits to ensure that the device's manufacturing processes continue to meet international standards.
• Internal Audits: Regular internal audits must be conducted to ensure that all quality processes are being followed and that the device continues to meet regulatory and safety standards.

7. Device Changes and Notifications

• Notify MDA of Changes: If there are any changes in the device’s design, materials, intended use, or manufacturing process, you must notify MDA. Some changes may require re-evaluation or re-registration of the device.
• Approval for Major Changes: For significant changes (e.g., change in the intended use of the device or a modification to its composition), you may need to submit a new application or request approval from MDA before continuing to market the modified device.

8. Maintain Communication with MDA

• Communicate with MDA: After approval, maintain open lines of communication with MDA for regulatory updates, new requirements, or guidance related to your device.
• Respond to Audits or Inspections: MDA may conduct post-registration inspections or audits to ensure ongoing compliance with medical device regulations. Be prepared for any such inspections and cooperate fully during the process.

9. Registration Renewal

• Prepare for Renewal: Class A medical devices typically need to be re-registered periodically. Monitor your device’s registration status and ensure that you submit any required documents or updates on time to renew your registration.
• Documentation Updates: Prior to renewal, you may need to submit updated information such as risk management reports, safety data, and manufacturing records.

10. Keep Records of Compliance

• Maintain Documentation and Records: Keep all records related to the device's registration, manufacturing, and post-market surveillance up to date. This may include:
  • Risk management documentation (e.g., hazard analysis, risk control measures)
  • Post-market surveillance records (e.g., adverse event reports)
  • Clinical data (if applicable)
  • Audit records (e.g., internal and external audits)
• Audit Readiness: Be ready for periodic audits by MDA or other regulatory bodies. Ensure all relevant records are easily accessible for review.

11. Distribution and Importation Compliance

• Authorized Representative Compliance: If the device manufacturer is located outside Malaysia, ensure that the Local Authorized Representative (LAR) in Malaysia continues to fulfill its responsibilities and remains compliant with MDA’s regulations.
• Importation Regulations: Ensure that the devices are properly imported and distributed in accordance with MDA guidelines and local customs regulations.

Summary of Requirements After Applying for Class A Medical Device Registration with MDA:

1. Submit Complete and Accurate Documents: Ensure all requested documents are provided to MDA and respond promptly to any additional information requests.
2. Adhere to Post-Market Surveillance (PMS): Monitor the device’s safety and performance after market introduction and report any adverse events.
3. Compliance with Labeling Requirements: Ensure that the device labeling remains accurate and in compliance with MDA standards.
4. Maintain ISO 13485 Certification: Continue to meet ISO 13485 standards for quality management and conduct regular internal audits.
5. Notify MDA of Changes: Report any changes to the device or its manufacturing process, and submit for approval if necessary.
6. Renew Registration: Ensure timely submission of documents for registration renewal.
7. Respond to Audits and Inspections: Be prepared for audits and maintain compliance with ongoing regulatory obligations.
8. Maintain Communication: Keep open communication with MDA for updates and compliance matters.

By following these requirements after applying for the registration of a Class A medical device, you can ensure that your device continues to meet MDA regulations and remains compliant throughout its lifecycle in the Malaysian market.

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