For the Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, there are several periodic updates and procedures that manufacturers must follow to ensure ongoing compliance with regulatory requirements. These updates relate to both the post-market phase and the re-registration process. Here are the key periodic updates and procedures:

1. Post-Market Surveillance (PMS) and Reporting

After the registration of a Class A medical device with MDA, manufacturers are required to maintain post-market surveillance to ensure that the device remains safe and effective in its use.

Periodic Updates:

• Adverse Event Reporting: If any adverse events, incidents, or malfunctions occur with the device, these must be reported to MDA in a timely manner. MDA requires the manufacturer to submit Adverse Event Reports when any serious incidents or device failures are identified, as well as the outcomes of any investigations or corrective actions taken.
• Corrective and Preventive Actions (CAPA): If any corrective actions are taken in response to adverse events, these actions must be documented and submitted to MDA. The CAPA plan should include information on the issue, the solution implemented, and the measures to prevent recurrence.
• Periodic Safety Updates: While Class A devices are low-risk, MDA still expects periodic safety updates from manufacturers. These updates may include an annual report summarizing the device's performance, any reported incidents, and any changes in safety data.

2. Re-registration and Renewal

Class A medical devices are typically subject to re-registration every five years. During the re-registration process, manufacturers must submit updated documentation to MDA to ensure that the device continues to comply with the regulations and that there have been no significant changes to the device that would alter its classification or safety profile.

Periodic Updates for Re-registration:

• Submit Updated Technical Documentation: Manufacturers need to provide updated technical documentation during the re-registration process. This may include:
  • New risk management reports
  • Updates to the Instructions for Use (IFU)
  • Any new clinical data (if applicable)
  • Post-market surveillance data or adverse event reports.
• Quality Management System (QMS) Updates: Manufacturers must ensure that their ISO 13485 quality management system is up to date and compliant with the latest standards. A re-certification audit by an accredited body may be required for continued compliance.
• Review of Compliance with Standards: The manufacturer should confirm that the device continues to meet relevant international standards (e.g., ISO 14971 for risk management, ISO 10993 for biocompatibility) and provide proof of compliance.

3. Device Changes and Notifications

Any changes to the device or its manufacturing process must be communicated to MDA. If any modifications are made, they could affect the safety, performance, or classification of the device. Therefore, periodic updates related to changes to the device must be submitted to MDA as follows:

Types of Changes That Require Notification or Re-Approval:

• Changes in Intended Use: If the intended use of the device changes (e.g., for a new medical condition or patient group), you must notify MDA.
• Changes in Design or Materials: Any modifications to the design, materials, or components of the device (e.g., a change in packaging material or manufacturing process) should be reported to MDA.
• Updates in Labeling: If there are changes to the labeling (e.g., addition of new warnings, new indications, or updates to instructions), these must be submitted for approval by MDA.
• Changes in Manufacturer Information: Any updates regarding the manufacturer’s details (such as a change in the manufacturing site or Local Authorized Representative (LAR)) must also be notified to MDA.

Process for Notification of Changes:

• Submit the change notification via MeDC@St, the online portal for medical device registration.
• Provide details about the nature of the change and any supporting documentation (e.g., updated labeling, risk assessments).
• MDA may review the changes and decide whether re-registration or further assessment is required.

4. Inspection and Audits

MDA may conduct post-market inspections or audits of your manufacturing facility, especially during the re-registration process. These inspections ensure that manufacturers continue to comply with the standards set by MDA, including compliance with Good Manufacturing Practice (GMP) and the ISO 13485 quality management system.

Periodic Inspections:

• MDA Inspections: These are usually conducted to verify that your facility is operating in compliance with Malaysian medical device regulations and that your devices meet the required safety and quality standards.
• Third-Party Audits: Manufacturers may also be subject to audits by third-party bodies for compliance with ISO standards or other regulatory requirements.
• Corrective Action: If any non-compliance is identified during an inspection or audit, the manufacturer must take corrective action and report it back to MDA within a stipulated time frame.

5. Market Surveillance and Compliance with New Regulations

MDA constantly updates its guidelines and regulatory requirements in response to new information, changing technologies, or evolving international standards. Manufacturers are required to stay informed about any changes to medical device regulations that may impact the device.

Periodic Updates on Regulatory Changes:

• Compliance with New Regulations: Manufacturers must ensure that their devices remain compliant with the Medical Device Act (Act 737) and the Medical Device Regulations 2012. This may include adapting to new labeling requirements, product classification guidelines, or risk management practices.
• Updates to Post-Market Surveillance: MDA may revise its guidelines for post-market surveillance, requiring additional reporting or data collection. Manufacturers must keep abreast of these changes and adjust their processes accordingly.

6. Device Importation and Distribution Updates

If there are any changes in the importation or distribution channels for the registered Class A device, such as a new distributor or changes in the authorized representative, these must be communicated to MDA.

• Update the Authorized Representative: If the Local Authorized Representative (LAR) changes, MDA should be notified.
• Importation Changes: Any new importers or changes in distribution practices should be updated in the MDA’s system.

Summary of Periodic Updates and Procedures for Class A Medical Device Registration with MDA:

1. Post-Market Surveillance: Report adverse events, maintain a corrective action plan (CAPA), and submit periodic safety updates.
2. Re-registration and Renewal: Submit updated technical documentation every 5 years, including safety data, risk management, and post-market surveillance reports.
3. Changes in Device or Manufacturing: Notify MDA of any changes in intended use, design, materials, labeling, or manufacturing processes.
4. Audits and Inspections: Prepare for periodic audits by MDA or third-party bodies to ensure continued compliance with regulatory and quality standards.
5. Compliance with Regulatory Changes: Stay informed about new regulations and adapt your device’s documentation and processes to meet evolving requirements.
6. Importation and Distribution Updates: Update MDA if there are changes to the local authorized representative or distribution network.

By ensuring compliance with these periodic updates and procedures, you will maintain a strong regulatory standing with MDA and ensure the continued safety and effectiveness of your Class A medical device on the Malaysian market.

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