NMPA accelerates approval process for medical protective clothing

Since Feb 7, 2020, in accordance with the previous deployment and arrangements of the supply security working group of State Council Joint Prevention and Control Mechanism, the National Medical Products Administration (NMPA) has been accelerating approval for medical protective clothing registration and manufacturing to further improve production capacity to support the prevention and control of the novel coronavirus epidemic.

The NMPA explicitly supports and encourages manufacturers of medical protective clothing to expand their production capacity. When a new production site is added to a medical protective clothing manufacturer, the NMPA will promptly handle the application in accordance with registration and production regulations for medical devices. 

The NMPA supports and encourages transformation of other manufacturing enterprises into producers of medical protective clothing. For protective clothing manufacturers that meet relevant export standards of the United States, the European Union, Japan and other countries and regions and those with certain production capacities for industrial protective clothing, registration will be completed promptly in accordance with registration and production regulations for medical devices, provided they can meet the GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use after improvement of production conditions and corresponding production quality management system.

The NMPA explicitly requires provincial drug regulatory departments to optimize the registration and licensing procedures for medical protective clothing. The local drug regulatory departments may handle registration applications of medical protective clothing in accordance with the Notice on the Issuance of Emergency Approval Procedures for Medical Devices(GuoShiYaoJianXie [2009] 565). For qualified products, product registration certificates and production licenses may be issued concurrently.

The NMPA requires all provincial drug regulatory departments to strengthen guidance for enterprises and help them meet the relevant requirements as soon as possible. Meanwhile, the provincial-level administrations should enhance supervision over product quality and safety and ensure that the enterprises conform to relevant laws and regulations.