China NMPA import suspension of Jeisys Medical Inc. laser surgery equipment

China NMPA import suspension of Jeisys Medical Inc.’s medical device follows a recent remote off-site inspection by China’s National Medical Products Administration (NMPA). Jeisys Medical Inc., a South Korean medical device manufacturer, had its Nd: Laser Surgery Equipment (Registration Certificate No.: GuoMeZhiJin20143015997) reviewed to assess compliance with China's stringent medical device regulations.

Key Findings from the Inspection:

The NMPA identified serious deficiencies in Jeisys Medical Inc.'s quality management system (QMS) during the inspection. These shortcomings impact the safety and effectiveness of the Nd: laser therapy device, raising significant concerns. The following issues were highlighted in the inspection report:

1. Production Traceability Deficiencies: Jeisys Medical Inc. demonstrated inadequate control over production traceability, which is critical in ensuring that all components and materials used in the device's manufacturing are accurately documented. Production traceability ensures that, in the event of a defect or recall, the origin of the issue can be quickly identified, and corrective actions can be implemented efficiently. The absence of a robust traceability system increases the risk of undetected defects in the product.
2. Product Testing Failures: The inspection revealed serious gaps in product testing protocols. Proper testing is crucial to ensure that medical devices meet safety, performance, and regulatory standards. Inadequate testing raises concerns about the device's reliability, which could lead to unsafe or ineffective treatments. The NMPA's findings indicated that Jeisys Medical's testing procedures were insufficient to guarantee the quality and safety of the Nd:laser therapy apparatus.
3. Lack of Corrective and Preventive Actions (CAPA): Jeisys Medical Inc. had failed to take appropriate corrective and preventive actions in response to previously identified issues. Specifically, the company did not address quality concerns related to unqualified items discovered during product sampling. CAPA is a fundamental part of any quality management system, designed to identify root causes of non-conformances and prevent their recurrence. The failure to implement CAPA indicates a lack of commitment to continuous improvement and risk mitigation, further compromising product safety.

Regulatory Action Taken:

In light of the serious quality and safety concerns identified during the inspection, the NMPA has taken immediate regulatory action to protect public safety. Effective immediately, the following measures have been implemented:

• Suspension of Importation: Jeisys Medical’s Nd: Laser Therapeutic Apparatus is prohibited from being imported into China. This means that no new shipments of this device can enter the Chinese market until further notice.
• Suspension of Operations and Use: All operations involving the Nd: laser therapy device, including distribution and use in medical facilities, have been suspended in China. Healthcare providers are no longer permitted to use the product, and any existing stock must be withdrawn from circulation.

These actions align with China's "Supervision and Management of Medical Devices Regulations" and "Supervision and Management of Medical Equipment Production" guidelines, which empower the NMPA to suspend or revoke the market access of medical devices that fail to meet regulatory standards.

Recommendations for Medical Device Manufacturers:

The situation with Jeisys Medical Inc. serves as a critical reminder for all medical device manufacturers with products registered in China. Compliance with local regulations is essential not only to maintain market access but also to ensure the safety and effectiveness of medical devices. To avoid similar regulatory actions, manufacturers should consider the following steps:

1. Strengthen Quality Management Systems (QMS): Ensure your QMS aligns with both international standards and specific Chinese regulatory requirements. This includes rigorous controls over production traceability, comprehensive product testing, and prompt implementation of corrective and preventive actions (CAPA) when issues arise.
2. Proactive Engagement with Regulatory Authorities: Maintain open lines of communication with regulatory bodies such as the NMPA. Proactive engagement helps companies stay informed about evolving regulations and address any compliance concerns before they escalate to suspension or other punitive measures.
3. Invest in Compliance Expertise: Partnering with a regulatory compliance firm specializing in the Chinese market can be invaluable. Such firms can provide expert guidance on navigating China’s complex regulatory landscape and ensuring that products meet all local requirements.
4. Conduct Regular Internal Audits: Periodically audit your manufacturing and quality processes to identify potential compliance gaps. Internal audits help ensure that all aspects of your operations are consistently meeting regulatory standards.

Further information

For more details, read the original NMPA announcement on China NMPA import suspension of Jeisys Medical Inc. laser surgery equipment.

Also, check our our previous articles on NMPA import suspension of SAMO SpA medical devices.

Contact Cisema if you would like to learn more about our services for NMPA overseas factory inspections and QMS adaptation.

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