Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China
China classifies medical devices including in vitro diagnostic reagents into three categories according to risk levels. Class I has the lowest level of risk and Class III has the highest. Coronavirus reagent test kits are classified as Class III medical devices.
Chinese health authority said on March 28 it received reports of 54 new confirmed COVID-19 cases on the Chinese mainland on March 27, all of which were imported. Three deaths and 29 new suspected cases were reported on the mainland, with all the deaths in Wuhan, Hubei province.
The overall confirmed cases on the mainland had reached 81,394 by the end of March 27, including 3,128 patients who were still being treated, 74,971 patients who had been discharged after recovery, and 3,295 people who died of the disease.
- NMPA Issued the Announcement on Issues Pertaining to the Implementation of the Drug Administration Law of the People's Republic of China
- The State Council's Leading Group for Deepening the Reform of the Medical and Health System Issued the Notice on Policies and Measures to Further Deepen the Reform of the Medical and Health System with Centralized Procurement & Use of Drugs as a Breakthrough
- NMPA Issued the Notice on the Implementation Plan of the State Council for Full-Coverage Pilot Reform of Separated Management of Permit and License in the Free Trade Pilot Areas