On September 18, 2021, the NMPA (National Medical Products Administration) announced the implementation of a work plan for strengthening the supervision of medical devices selected for centralized procurement in China as an effective measure to ensure product quality and safety.
The NMPA and the provincial MPAs will further effectively enhance their supervision work in future by taking the initiative to collect the information of the suppliers in time. Through the full implementation of the main responsibility of the suppliers for quality and safety and through the enhancement of the supervision responsibility of the regulatory departments, the NMPA intends to achieve a full-coverage inspection and a full-coverage sampling to effectively guarantee the quality and safety of the selected medical devices in the centralized procurement with quantity.
The work plan focused on:
- The responsibility of the suppliers.
- Report promptly to the local provincial MPA (medical products administration). The registration agent of imported medical devices shall also report the selection status to the local MPA timely.
- Strengthen quality management. In accordance with the requirements of medical device laws and regulations and the provisions for production quality management, the manufacturers shall continue to improve the quality management system, improve the quality management level, strengthen raw material audit and supplier management, carefully investigate hidden risks in the production process, and effectively strengthen the quality control of the production process. The companies shall also take effective measures to ensure that product quality meets the mandatory standards and the technical requirements of registered product.
- Strictly carry out adverse event monitoring. The manufacturers shall implement relevant regulatory requirements for adverse events, strengthen the collection, reporting, analysis and handling of adverse events, and strengthen the life-cycle risk management of selected products.
- Establish a sound tracing system. In accordance with the requirements for the implementation of the unique identification of medical devices, the companies shall carry out product code assignment, data upload and maintenance, establish and improve the tracing system based on the unique identification, and do a good job in product recall, product trace and other related work.
- Effectively strengthen the supervision and management of the selected enterprises.
- Strengthen the daily supervision of the selected enterprises and realize the management of “One company, one file”.
- Strengthen the supervision and inspection of the selected enterprises, and achieve full-coverage inspection every year (unannounced inspection).
- Supervise the selected companies on a quarterly basis, require each company to report the system operation and product quality status.
- Organize and carry out special trainings on a regular basis with the company’s responsible person, management representatives, etc., and assess their understanding on the latest laws and regulations, product standards, and regulatory requirements for medical devices. The assessment results will be registered in the corporate credit file.
By Judith Sun. Contact Cisema if you would like to learn more.