NMPA Issued 7 Guidances for Technical Review Including the Guidance for Technical Review of the Registration of Vertebroplasty Balloon Dilation Catheters
To strengthen the supervision and guidance over medical device product registration and further improve the quality of registration review, NMPA has organized the formulation of the Guidances, which have been released on May 9, 2020.
To fully reflect the monitoring of adverse events in relation to China's medical devices in 2019, the National Center for Adverse Drug Reaction Monitoring has compiled and released on April 26, 2020 the Annual Report for National Medical Device Adverse Event Monitoring (2019).
To fully reflect the status of China's adverse drug reaction (ADR) monitoring in 2019, improve the level of safe drug use, and better ensure drug safety for the public, the National Center for ADR Monitoring has organized the compilation of the Annual Report for National Adverse Drug Reaction Monitoring (2019), which has been released on April 10, 2020.
According to the work deployment, the UDI database was officially launched on December 10, 2019, with database sharing function opened on March 31, 2020.
Announcement of NMPA on Revising the Package Inserts of hydrocortisone injection and hydrocortisone sodium succinate for injection
NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of hydrocortisone injection and hydrocortisone sodium succinate for injection.
NMPA issued the 2019 Annual Report for Medical Device Registration, which covers five parts: medical device registration status, medical device registration application acceptance status, medical device registration approval status, innovative medical device registration approval status, and other registration management status.