Once the registration of Class B medical devices in Malaysia is approved, there are several important obligations and considerations that the manufacturer, importer, or local authorized representative must follow to remain compliant with the Medical Device Authority (MDA). Here are key points to note:

1. Validity of Registration

• Registration Period: The medical device registration is valid for five years from the date of approval.
• Renewal: You must apply for a renewal of the registration at least six months before the expiration date to avoid disruptions in marketing and selling the device in Malaysia. Renewal applications must include updated documentation, including any changes to the device, its labeling, or regulatory status.

2. Post-Market Surveillance (PMS)

• PMS Requirements: After registration, you are required to conduct post-market surveillance (PMS) to ensure the ongoing safety, performance, and quality of the device. This includes:
  • Monitoring for adverse events.
  • Collecting data on device performance in real-world settings.
  • Conducting regular safety reviews.
• Incident Reporting: Report any adverse events, malfunctions, or safety concerns to MDA as part of Malaysia’s vigilance reporting system. This must be done promptly, especially in cases involving serious injury or death.

3. Field Safety Corrective Actions (FSCAs)

• Recalls and Corrective Actions: If any issues arise with the device that could compromise safety or performance, you are required to initiate a field safety corrective action (FSCA), which may include product recalls or modifications.
• Notifying MDA: You must notify the MDA of any FSCAs taken, including the reason for the action, the scope, and the plan for resolving the issue.

4. Compliance with Good Distribution Practice for Medical Devices (GDPMD)

• GDPMD Requirements: Distributors, importers, and other supply chain entities must comply with GDPMD to ensure that medical devices are stored, handled, and distributed appropriately, maintaining their safety and quality.
• GDPMD Audits: Be prepared for MDA to audit distributors and local authorized representatives to confirm compliance with GDPMD.

5. Labeling and Advertising

• Maintaining Labeling Compliance: Ensure that your device continues to comply with Malaysian labeling regulations, including any updates to symbols, instructions, or warnings.
• Changes in Labeling: If there are any changes to the labeling or instructions for use, you must notify MDA and submit updated labeling for approval.
• Advertising Guidelines: Comply with MDA’s advertising regulations, ensuring that any claims made about the device’s safety and efficacy are accurate, supported by evidence, and do not mislead consumers.

6. Change Notification (Amendments)

• Notifying MDA of Changes: If any changes are made to the device after registration (e.g., changes in design, materials, manufacturing processes, or intended use), you must notify the MDA. Some changes require a formal amendment process and approval before they can be implemented.
• Minor vs. Major Changes: Be aware that major changes (e.g., changes affecting the device’s safety or efficacy) may require additional evaluations or clinical evidence, while minor changes (e.g., administrative updates) can be reported through a simpler process.

7. Continuous Monitoring of Regulatory Updates

• Stay Updated: Keep track of any changes to Malaysian medical device regulations or MDA guidelines. Regulatory updates could affect ongoing compliance, post-market surveillance, or the need for re-registration or modification of devices.
• Follow New Requirements: Implement any new requirements as stipulated by the MDA, whether related to labeling, surveillance, or reporting obligations.

8. Handling Complaints

• Complaint Handling System: Maintain a robust system for receiving, investigating, and responding to customer complaints or feedback. The complaint records must be kept and made available to MDA if requested.
• Timely Responses: Ensure complaints related to safety, performance, or labeling are addressed promptly, and any corrective actions are documented and reported as necessary.

9. Local Authorized Representative (LAR) Responsibilities

• LAR Ongoing Obligations: If you are a foreign manufacturer, your Local Authorized Representative (LAR) will have ongoing responsibilities to act as the liaison with MDA, including handling vigilance reporting, post-market surveillance, and any regulatory submissions on your behalf.
• Keeping LAR Details Updated: Ensure that the LAR’s contact information and registration status remain up-to-date with MDA.

10. Periodic Audits and Inspections

• Be Prepared for Inspections: The MDA may conduct periodic audits and inspections of your manufacturing facilities, distribution centers, or authorized representatives to ensure ongoing compliance with Malaysian regulations.
• QMS Audits: If your device was approved based on compliance with ISO 13485 or other QMS certifications, you may need to demonstrate ongoing adherence to those quality standards.

11. Monitoring Device Performance in Other Markets

• International Surveillance: If your device is marketed in other countries, stay informed of any regulatory actions (e.g., recalls, alerts) taken by foreign regulatory bodies such as the US FDA or the European Medicines Agency (EMA), and assess whether similar actions are necessary in Malaysia.
• Global Vigilance Reporting: If any adverse events or recalls occur in other markets, notify the MDA and assess the need for corrective actions in Malaysia.

12. Renewal of Registration

• Start Early: Initiate the renewal process at least six months before the registration expires to ensure that the device remains on the market without interruption.
• Provide Updated Documents: When renewing, update the MDA with any changes to the device, manufacturing process, or post-market surveillance data.

13. Compliance with Environmental Regulations (if applicable)

• Environmental Impact: Ensure that your device complies with any environmental regulations related to medical devices in Malaysia, such as proper disposal methods, especially for electronic devices or those containing hazardous materials.

14. Enforcement Actions and Penalties

• Non-Compliance Consequences: Failure to comply with the above obligations can result in penalties, including fines, suspension, or cancellation of your device’s registration.
• Corrective Action: If MDA identifies compliance issues, you will be required to take corrective action to avoid penalties or removal from the market.

15. Device Vigilance System Participation

• Active Reporting: Participate actively in MDA’s device vigilance system by submitting periodic reports, particularly for devices with higher risk profiles, and complying with post-market surveillance data requests.

By adhering to these post-approval requirements, you ensure continued compliance with Malaysian regulations and maintain the right to market your Class B medical device in Malaysia. Regularly monitoring the device's performance and ensuring adherence to regulatory changes are critical for long-term success in the Malaysian market.

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