Medical device entrusted production will be subject to enhanced supervision measures following an announcement by the National Medical Products Administration (NMPA) on April 3, 2024. This initiative follows the principles set out in the “Regulations on Supervision and Administration of Medical Devices” and aims to enforce the quality and safety responsibilities of medical device registrants. The new measures will come into effect on June 1, 2024.
Registrant responsibilities regarding entrusted production
- Selection of Entrusted Manufacturers: Registrants must prioritize manufacturers with high-quality management levels, larger production scales, good credit records, and advanced levels of automation and information management. Before commissioning, the registrant should review the manufacturer’s credit and regulatory compliance information.
- Implantable Medical Devices: There is a strong encouragement for registrants to produce implantable devices themselves. If outsourcing is necessary, registrants must station experienced quality management personnel at the manufacturing site to supervise and ensure compliance with legal and technical standards.
- Quality Agreements: Quality agreements must be crafted according to the “Medical Device Entrusted Production Quality Agreement Preparation Guidelines,” reflecting the actual conditions of the enterprise. These agreements should define the operational lifespan no longer than the validity of the product registration and production licenses.
- Quality and Safety Obligations: Registrants are required to implement a quality management system covering the entire lifecycle of medical devices. This includes establishing appropriate management structures that correspond to the scale of the operation and product features of the contracted production. Responsibilities such as risk management, change control, product release, after-sales service, complaint handling, adverse event monitoring, and product recalls must be clearly defined and regularly audited.
- Integration and Oversight: Registrants must integrate the requirements of the quality agreements into actionable management documents and supervise the entrusted manufacturer’s adherence to these standards. The use of controlled information technology systems to optimize contract manufacturing processes is encouraged.
- Critical Raw Materials: Registrants must establish acceptance criteria and audit procedures for critical materials and suppliers, particularly for outsourced components like sterilization processes or critical components in active devices.
- Cross-contamination Risks: Contract manufacturers sharing production facilities or equipment must establish management systems to prevent product mix-ups or contamination, with registrants providing supervision to enforce these risk control measures.
- Release Procedure: When medical device registrants outsource production, they must establish and directly manage product release procedures, ensuring compliance with specified standards and conditions.
- Preventive Measures: Registrants and contract manufacturers must clearly define in their quality agreements the communication mechanisms for corrective and preventive measures, responsibilities of both parties, and handling requirements. They must also develop corrective and preventive control procedures that are appropriate for the product’s risk profile.
- Change Control Capability: Registrants must enhance their change control capabilities and work with contract manufacturers to establish comprehensive change control procedures, including change assessment, verification, or confirmation. They should conduct risk assessments to determine if changes, such as the introduction or modification of outsourced research and development, production processes, or services, affect the effective operation of the quality management system and ensure proper change control is maintained.
- Monitor Adverse Events: Registrants which contract entrusted manufacturers must comply with established regulations for monitoring adverse events. They should ensure adequate resources and systems are in place for event monitoring, investigation, and risk assessment. Responsibilities for handling adverse events must be explicitly defined in the quality agreements, and registrants cannot transfer their legal monitoring obligations to contract manufacturers.
Strengthened medical device entrusted production registration management
- Integration into Quality Management Systems: Registrants must integrate the contract manufacturing process into their quality management systems, detailing procedures and data related to measuring, analyzing, and improving the operations of their contract manufacturers in their registration applications.
- Quality System Audits: Quality management system audits should focus on the establishment of quality departments, staffing, and the performance of key personnel, as well as the status of quality agreements and management of outsourced R&D and production. In cases of cross-regional domestic contract manufacturing, the audits are primarily conducted by regulatory bodies from the registrant’s and manufacturer’s locations, ensuring comprehensive inspection and compliance.
- Registration Documentation and Reporting: The registration and renewal applications must include the contract manufacturing address and details in the medical device registration certificate, clearly labeled as “contract production.” Changes in the contract manufacturing setup must be updated in the registration documents and reported according to the national medical product regulation data sharing requirements.
Further information
Read the original announcement on Strengthening Medical Device Registrants Entrusted Production Supervision and Administration.
Discover our services for medical device registration, renewals and NMPA Legal Agent.
GET IN TOUCH
