After obtaining Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, several ongoing regulatory requirements and responsibilities must be adhered to in order to maintain compliance. These regulations and requirements ensure that your device continues to meet safety, quality, and performance standards throughout its lifecycle. Below are the key regulations and requirements that must be followed:

1. Post-Market Surveillance (PMS)

• Monitoring Device Performance: Once your device is on the market, you must continue to monitor its performance. This includes tracking and addressing any adverse events, device failures, or user complaints.
• Reporting Adverse Events: If any adverse events (such as injuries, malfunctions, or product failures) occur, they must be reported to the MDA. The reporting timeline and procedures are governed by the Medical Device Act 2012 and related regulations.
  • Timely Reporting: Adverse events or incidents that could potentially harm users must be reported within 30 days of becoming aware of the issue.
  • Corrective Actions: If an issue is identified, you must take appropriate corrective actions, such as issuing product recalls, repairs, or replacements, and notify the MDA accordingly.

2. Quality Management System (QMS) Maintenance

• ISO 13485 Compliance: Maintain a robust Quality Management System (QMS) that adheres to ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes). This ensures your manufacturing processes are controlled, and the products consistently meet safety and performance standards.
  • The QMS should be regularly audited to verify that your processes are in compliance with both the MDA regulations and international standards.
• Regular Internal Audits: Conduct regular internal audits to verify that your processes, documentation, and controls are functioning as required. Internal audits should be conducted annually or as specified in your quality procedures.
• External Audits and Inspections: Be prepared for MDA inspections or audits of your manufacturing facilities and processes. These may be random or triggered by concerns, complaints, or non-compliance.

3. Device Labeling and Instructions for Use (IFU)

• Accurate and Updated Labeling: Ensure that the labels and Instructions for Use (IFUs) for your device remain accurate, clear, and compliant with the MDA's requirements. Any changes to the device (such as updates in design or function) must be reflected in the labeling.
• Language Requirements: The device labeling and IFUs must be in both English and Malay. Ensure that all information is provided in a manner that is easily understood by end-users, including any safety warnings and usage instructions.

4. Renewal of Registration

• Five-Year Renewal Cycle: Medical device registration with the MDA is valid for five years. After this period, you must apply for renewal of the registration to continue marketing the device in Malaysia. The renewal application typically requires updated documentation, including any changes to the device or its manufacturing processes.
  • Renewal submissions should be done at least 6 months before the expiry date to allow for processing.
  • You may need to pay a renewal fee as per the MDA's fee schedule.

5. Changes to the Device

• Notification of Changes: If there are any changes to the device, such as modifications to its design, materials, manufacturing process, or intended use, you must notify the MDA.
  • For major changes, you may be required to submit a new application or update your registration documentation.
  • For minor changes, a notification to the MDA may suffice, but ensure that the changes do not affect the safety, effectiveness, or performance of the device.
• Updates to Risk Assessment: If any changes are made to the device, the risk management process (according to ISO 14971) should be updated to reflect the new risks and mitigation strategies.

6. Reporting and Documentation

• Adverse Event Reports: Ongoing submission of adverse event reports is required. All incidents must be documented, analyzed, and communicated to the MDA according to the regulatory guidelines.
• Clinical Follow-up (if applicable): If your device requires clinical follow-up, ensure that the clinical data is collected and submitted as needed. This may include long-term performance studies or post-market clinical follow-up (PMCF) data.

7. Authorized Representative (AR) Compliance

• AR Responsibilities: If you are a foreign manufacturer, your Authorized Representative (AR) in Malaysia must continue to fulfill their regulatory obligations, including:
  • Ensuring that the device remains in compliance with Malaysian regulations.
  • Coordinating with the MDA on matters related to adverse events, recalls, or inspections.
  • Updating the MDA if the AR’s contact information or other registration details change.

8. Device Recalls and Corrective Actions

• Recalls: If a safety issue or regulatory non-compliance is identified, you may need to initiate a product recall. The MDA must be informed immediately, and you must ensure that affected products are removed from the market.
  • The recall process involves identifying and retrieving affected products, notifying customers, and taking corrective action to prevent future occurrences.
• Corrective and Preventive Actions (CAPA): Maintain a CAPA system to address identified issues in the device's design, manufacture, or performance. Corrective actions should resolve immediate problems, while preventive actions should address underlying causes to prevent recurrence.

9. Reporting to the MDA

• Regular Updates: Provide the MDA with updates on the device’s performance, adverse events, and any other relevant changes. This helps ensure that the device remains compliant throughout its lifecycle in Malaysia.
• Registration Amendments: If there are changes in the manufacturing process, device specifications, or other critical aspects, you must notify the MDA and update the registration as necessary.

10. Market Surveillance

• Compliance Inspections: Be prepared for the MDA to conduct market surveillance to monitor the ongoing safety, performance, and compliance of your device in the market. This may include inspections of importers, distributors, and local retailers.
• Product Quality Monitoring: Continue to assess the product’s quality through post-market monitoring and report any findings to the MDA as required.

11. Importation and Distribution Compliance

• Licensed Importer: If your device is imported into Malaysia, ensure that the importer is properly licensed with the MDA and complies with all importation requirements.
• Distribution Compliance: Ensure that distributors comply with the MDA’s regulations for the marketing and sale of medical devices in Malaysia. The distributor must ensure that the devices sold meet safety and performance standards.

Summary of Post-Registration Obligations:

1. Post-market surveillance and timely reporting of adverse events.
2. Maintain ISO 13485 compliance and a quality management system.
3. Update labeling and IFUs as necessary.
4. Renew device registration every 5 years.
5. Notify MDA of changes to the device or manufacturing processes.
6. Implement corrective actions and initiate recalls when needed.
7. Ensure ongoing compliance from your Authorized Representative (for foreign manufacturers).
8. Ensure market surveillance through regular checks and inspections.

By following these regulations and requirements after obtaining registration, you will help ensure the continued safety, efficacy, and compliance of your Class A medical device in the Malaysian market.

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