China NMPA Strengthens Supervision Of Medical Device Registrants Contract Manufacturing

In June 2021, the new Regulations on the Supervision and Administration of Medical Devices officially came into effect, marking the full implementation of the medical device registrant system.

In July 2023, an experience exchange meeting on implementing manufacturing quality management standards under the medical device registrant system was held. It emphasized the need for provincial drug regulatory departments to strengthen quality supervision throughout the entire lifecycle of medical devices and further implement local regulatory responsibilities. Attention was also drawn to different types of registrants, such as those engaging in cross-regional contract, multi-point contract, and self-manufacturing to contract manufacturing, with targeted regulatory measures to mitigate risks.

The latest “Announcement” further refines the requirements for supervising medical device registrants contract manufacturing. It specifies:

• Strict implementation of the primary responsibilities of medical device registrants.
• Strengthening the management of medical device contract manufacturing by registrants.
• Continued enhancement of supervision over contract manufacturing.

Key points include:

• Registrants should prioritize selecting enterprises with higher quality management levels, larger manufacturing scales, good credit records, and higher levels of automation and informatization for contract.
• Registrants should fully implement their responsibilities for medical device quality and safety, establish a quality management system covering the entire lifecycle of medical devices, and ensure its effective operation.
• For implantable medical devices, registrants are encouraged to self-produce. If contract manufacturing is necessary, registrants should preferably assign personnel with relevant manufacturing quality management experience to the contract enterprise.
• For critical procurement items or major raw materials, such as animal-derived raw materials, outsourced sterilization processes, key components/parts/modules of active products, and antigens and antibodies for in vitro diagnostic reagents, registrants should establish procurement acceptance standards and conduct supplier audits either independently or in conjunction with contract enterprises.
• In cases involving cross-regional contract manufacturing, regulatory information such as product types, inspection results, and responsibility interviews should be promptly communicated between the registrants, contract enterprises, and provincial drug regulatory departments in accordance with relevant regulations.
• Drug regulatory departments are encouraged to explore conducting simultaneous supervision and inspections at both registrant and contract enterprise sites, utilizing network remote connection and other information technology means to facilitate timely communication of inspection information and standardize inspection procedures.

This comprehensive approach aims to enhance the quality management and regulatory oversight of medical devices throughout the manufacturing process, ensuring their safety and effectiveness in the market.