Drug regulatory departments adopt emergency approval for urgently-needed medical devices

To fight against the novel coronavirus epidemic, under the guidance of the National Medical Products Administration, several provincial-level medical products administrations have recently accelerated approval of urgently-needed medical devices in accordance with the principle of "unified command, early consultation, rapid and science-based review and approval" without compromising the requirement to ensure product safety, effectiveness and quality management.

As of 4 pm on Feb. 5, relevant provincial administrations had, in accordance with the procedures of emergency approval for medical devices, approved 72 medical device registration applications, including 2 protective masks, 14 surgical masks, 17 single-use medical masks, 9 single-use protective gowns, 10 single-use surgical gowns, 2 reusable surgical gowns, 2 single-use medical caps, as well as single-use surgical caps, medical isolation beds, isolation compartments for medical use, single-use surgical towel bags, single-use aseptic operation sheets, single-use medical gloves for medical checks, single-use surgical gloves, non-invasive ventilators, nasal catheters, heated breathing circuit kits, infrared thermometers, high flow humidified oxygen delivery apparatus, digital portable X-ray machines, single-use interventional surgery kits, single-use endotracheal intubation kits, and single-use sputum suction bags. 

According to the NMPA's statistics, at present, medical device registration certificates have been issued to 65 protective face masks, 164 surgical masks, 334 single-use masks, and 50 single-use protective gowns across the country. While ensuring product safety and effectiveness, drug regulatory authorities spare no effort in satisfying the demand of epidemic prevention and control.

The NMPA requires local administrations to strengthen supervision of the newly approved medical devices and to urge the manufacturing enterprises involved to carry out their major responsibilities and operate in accordance with laws and regulations to ensure product safety and quality.

Tips: Masks for medical use can be classified into protective face masks, surgical masks, and single-use medical face masks. Protective face masks have a type of self-inhalation filter used to block particulate matter in the air, as well as foams, blood, body fluid and secretion in the medical environment. They shall be manufactured in accordance with the GB 19083-2010 Technical Requirements for Protective Face Masks for Medical Use. Surgical masks are used by clinical medical personnel during invasive manipulation, and shall be manufactured in accordance with the specifications of the YY 0469-2011 Surgical Mask. Single-use medical face masks are used in general medical environment to block contamination from oral or nasal discharge. They shall be manufactured in accordance with the YY/T 0969-2013 Single-use Medical Face Mask.