After obtaining Class A medical device MDA registration in Malaysia, manufacturers and authorized representatives are required to provide regular updates to the Medical Device Authority (MDA) to ensure the device remains compliant with ongoing regulatory requirements. These updates are crucial to maintaining the registration and ensuring the device's safety and efficacy throughout its lifecycle. Below are the standards and procedures for providing regular updates for Class A medical device MDA registration in Malaysia:

1. Routine Registration Renewal (Every 5 Years)

• Timeline: The registration for Class A medical devices with the MDA is valid for five years. To maintain the device's market authorization, a renewal application must be submitted at least 6 months before the expiry date.

• Required Documentation for Renewal:

  • Updated Technical Documentation: Submit the latest technical files, including risk management reports, device labeling, and IFU updates, if applicable.
  • Declaration of Conformity: A declaration confirming that the device continues to meet the Medical Device Regulations in Malaysia, as well as any relevant international standards (e.g., ISO 13485, ISO 14971).
  • Updated Product Information: Include any changes in manufacturing processes, quality control, or product specifications.
  • Post-market Surveillance Reports: Include a summary of the post-market surveillance (PMS) activities conducted since the previous registration.
  • Renewal Fee: Pay the renewal fee as stipulated by the MDA.

• Process:

  • Log in to the MDA’s Medical Device Registration System (MDRS).
  • Complete the renewal application online and submit the required documents.
  • The MDA will assess the renewal application, which can take several months to process.

2. Notifications of Changes to the Registered Device

If any changes occur in the design, manufacturing process, or intended use of the device, these must be reported to the MDA. Some changes require the submission of an updated registration, while others may only require notification, depending on the significance of the change.

Types of Changes That Must Be Reported:

• Device Modifications: Any alterations to the device's design, functionality, or intended use.
• Manufacturing Changes: Changes in the manufacturing location, processes, or suppliers that affect the device's quality or performance.
• Updates to Risk Management: Any changes to the risk management process that impact the safety or performance of the device.
• Clinical Data or Test Reports: If new clinical data or test results are generated that may affect the device’s safety or performance, these should be submitted.
• Changes in Labeling or Instructions for Use (IFU): Any updates to labeling requirements, including language changes or additional warnings.
• Post-Market Surveillance Results: Updates from post-market surveillance activities, including any significant findings that affect device safety or effectiveness.

Procedure for Reporting Changes:

• Minor Changes: For some changes, such as updates to labeling or changes that do not affect the device's safety or performance, a notification may be sufficient. These changes can be submitted via the MDA's online registration system (MDRS).
• Major Changes: For more significant changes, such as alterations in device design or intended use, a new application or amendment to the registration may be required. This involves submitting new documentation, such as updated technical files, risk assessments, or clinical data.

3. Adverse Event Reporting and Corrective Actions

• Adverse Event Monitoring: Manufacturers must monitor the safety and performance of their medical device in the market and track any adverse events (e.g., malfunctions, injuries, or device failures).
• Reporting Adverse Events: If an adverse event occurs or if there is a risk to public health, the manufacturer or authorized representative must report the incident to the MDA within 30 days of becoming aware of it. This is part of the post-market surveillance system.
  • Adverse Event Report: The report must include details of the incident, the device involved, corrective actions taken, and any recalls if applicable.
  • Corrective and Preventive Actions (CAPA): If a safety issue or regulatory non-compliance is identified, the manufacturer must initiate corrective and preventive actions (CAPA). This can include issuing product recalls, providing user training, or modifying the device or its processes.

Procedure for Reporting Adverse Events:

• Report incidents through the MDA’s online platform or directly to the MDA using the appropriate forms provided for adverse event reporting.
• Provide a detailed analysis of the event, including the impact on the device’s safety or performance, and any measures taken to resolve the issue.

4. Post-Market Surveillance (PMS) Reporting

• Post-Market Surveillance Activities: Manufacturers are required to perform ongoing post-market surveillance to assess the long-term safety and effectiveness of their medical devices in the market. This includes collecting and analyzing customer feedback, complaint reports, and any safety incidents.
• PMS Reports: Manufacturers must provide the MDA with periodic PMS reports, summarizing the surveillance activities and outcomes. This ensures that any emerging issues or trends are detected and addressed promptly.

Procedure for PMS Reporting:

• Annual Report: Submit an annual PMS report to the MDA, summarizing the findings from your ongoing surveillance.
• Frequency of Reporting: The frequency of updates may depend on the device's risk classification and any issues identified during the PMS. For lower-risk devices like Class A, periodic reporting may be sufficient unless there are significant findings.

5. Inspection and Audits by MDA

The MDA conducts random inspections or audits of registered medical devices, manufacturers, and authorized representatives to ensure ongoing compliance with the regulatory requirements. During these inspections, you may be asked to provide updated documentation, such as:

• Quality System Records: Evidence of compliance with ISO 13485 or other relevant standards.
• Device Specifications: Updated technical files and records of any modifications made to the device.
• Adverse Event and Recall Data: Records of any reported adverse events or product recalls.

Procedure for Inspections:

• Be prepared for an inspection by having all the required documentation readily available for MDA auditors.
• Respond promptly to any findings or non-compliance issues raised during the inspection, and implement corrective actions as needed.

6. Device Labeling and Packaging Updates

Ensure that the labels and packaging for your device remain compliant with MDA regulations. If there are any updates to the device’s warnings, instructions, or indications, these must be incorporated into the labeling and packaging.

• Language Compliance: Ensure that labels and IFUs are in both English and Malay, as required by MDA.
• New Regulatory Requirements: Be aware of any changes in local regulations that might require label updates.

Procedure for Labeling Updates:

• Submit updated labels and packaging details to the MDA when significant changes are made.
• Ensure compliance with any new standards or guidelines that the MDA may issue.

Summary of Regular Updates After Registration:

1. Device Registration Renewal: Submit for renewal every 5 years with updated documentation.
2. Notification of Changes: Report any changes to the device, manufacturing processes, labeling, or intended use.
3. Adverse Event Reporting: Report adverse events to the MDA within 30 days and implement corrective actions.
4. Post-Market Surveillance: Submit annual or periodic post-market surveillance reports to monitor device safety.
5. Prepare for MDA Inspections: Ensure compliance with regulatory requirements and be prepared for inspections.
6. Update Labeling and Packaging: Ensure that labeling and packaging are in compliance with local regulations and any changes are reported.

By following these procedures, manufacturers and authorized representatives can ensure that their Class A medical devices remain compliant with Malaysian regulatory requirements throughout their lifecycle, maintaining safety and effectiveness for users.

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