China Guomen Time:

How does the National Medical Products Administration (NMPA) strengthen supervision over critical epidemic prevention and control supplies, including COVID-19 detection reagents, surgical masks, medical protective suits, respirators and infrared thermometers, to ensure their quality and safety? Thank you.

Zhang Qi:

Thank you for your question. Since the outbreak of the epidemic, the NMPA has strictly implemented the policy decisions and plans of the CPC Central Committee and the State Council and taken strong measures to comprehensively step up quality supervision over medical devices for epidemic prevention and control.

First, supervision and inspection are enhanced. The NMPA has increased the supervision and inspection of manufacturers over their key production chains, including raw material purchasing, process control and the release of products from factories, to press their production in strict accordance with regulations and standards. In case of any problem found, the enterprise shall be ordered to make complete rectification to resolutely prevent unqualified products from entering the market and guarantee the quality and safety of medical devices at the origin.

Second, safety inspection is improved. By the end of March, a total of 8,069 inspections in the form of emergency registration inspections, emergency evaluation inspections and supervised sampling inspections had been conducted on medical devices for epidemic prevention and control. The result shows the medical devices meet quality requirements on the whole.

Third, supervisory checks are enhanced. The NMPA and the State Administration for Market Regulation (SAMR) have dispatched several competent law enforcement officers to 14 key provinces and provincial cities, including Beijing, Tianjin, Zhejiang, Hubei and Guangdong to supervise and inspect the local quality control of medical devices for epidemic prevention and control and to ensure that all measures are implemented with full attention to detail.

Fourth, violations of laws and regulations are being tackled. The NMPA has worked with seven other departments to jointly crack down on violations of manufacturing and selling counterfeit and inferior medical devices to ensure the quality and safety of medical devices for epidemic prevention and control. Relevant cases of punishment have been released at the NMPA's official website.

Fifth, registration information is released promptly. Relevant registration information of the approved products has been released at the NMPA's official website and updated, subject to approval, to serve for the reference of purchasers and provide convenience for the relevant departments in the supervision of exports.

Next, the NMPA will cooperate with other departments to jointly supervise the quality of medical devices for pandemic prevention and control and guarantee supplies for battling the virus, protecting lives and the health of more people. Thank you.

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