On April 26th, the State Council's Joint Prevention and Control Mechanism held a press conference on strengthening the quality supervision of medical prevention and control material exports. At the meeting, Wang Shucai, Deputy Director of the Medical Device Supervision Department of the National Medical Products Administration, stated that since the outbreak of the epidemic, the National Medical Products Administration has taken a series of measures to comprehensively strengthen the quality supervision of medical devices for epidemic prevention and control. While fully ensuring the needs of domestic epidemic prevention and control, it actively assists in international epidemic prevention and control. The National Medical Products Administration has carried out special scheduling, supervision and inspection of key tasks, strengthened the implementation of various responsibilities, and carried out five aspects of work.

Wang Shucai introduced that firstly, establish a list of export enterprises and strengthen the supervision of key enterprises. Require provincial drug regulatory authorities to establish a list of export medical device enterprises, implement dynamic adjustments, supervise and guide export enterprises to improve their export product archives, effectively ensure the traceability of the export process, timely report the list of export enterprises to the local government, and urge local governments to strengthen their territorial management responsibilities.

The second is to further standardize export sales certificates and strictly enforce the conditions for issuing certificates. The Notice on Strengthening the Administration of Export Sales Certificates of Medical Devices for the Prevention and Control of the COVID-19 was issued, requiring provincial bureaus to strictly follow the regulations on the administration of export sales certificates of medical devices, and not to issue export sales certificates without obtaining medical device registration certificates and production licenses in China.

The third is to determine the key inspection content and increase supervision and inspection efforts. Each provincial bureau shall establish a list of regulatory responsibilities based on the list of export enterprises, and assign the regulatory responsibilities of each export enterprise to individuals. Targeting key targets, focusing on key links, highlighting problems, and strengthening control measures. If there is evidence to indicate that there are quality problems with exported products, production should be immediately stopped for rectification, and the problem should be investigated. If the problem is not verified and the responsibility is not clearly defined, production and operation cannot be resumed.

The fourth is to strengthen supervision and sampling efforts around key export products, requiring provincial drug regulatory departments to adjust sampling items in a timely manner according to the needs of epidemic prevention and control and the need to ensure the quality of export products, and increase sampling efforts for the five major categories of exported medical devices. Sampling inspection covers all types of products produced by enterprises in this province, especially those newly approved for production by enterprises during the epidemic prevention and control period.

The fifth is to jointly carry out supervision and inspection, and strengthen the implementation of responsibilities by all parties. The National Medical Products Administration, together with relevant departments and bureaus of the State Administration for Market Regulation, formed a joint supervision group to conduct special inspections in five provinces and cities with large exports of medical devices for epidemic prevention and control. They conducted on-site inspections of medical device production and operation enterprises, timely reported the results of the inspections to local governments, further strengthened local management responsibilities, and made every effort to ensure the product quality of exported medical devices.

Wang Shucai stated that as of April 24th, drug regulatory authorities in various regions have dispatched 10307 inspectors to inspect 1216 medical device manufacturing enterprises that have already conducted export business and are preparing to do so, with a total of 6435 inspections; Supervise and inspect 417 batches of products. The National Medical Products Administration will work with relevant departments to continue strengthening the quality and safety management of exported medical devices, ensuring product safety, effectiveness, and controllable quality.