Provisions for Medical Device Adverse Event Monitoring and Re-evaluation (SAMR Decree No.1) Issued on August 31, 2018 The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the Nation
Release of Annual Report for National Medical Device Adverse Event Monitoring (2018) Updated: 2019-10-30 To fully reflect the monitoring of adverse events in China's medical devices in 2018, the National Center for Adverse Drug Reaction Monitoring has compiled and released on Octo
NMPA Issued the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Organizations Medical device inspection and testing system constitutes an important part of the medical device supervision system, per the Thirteenth Five-Year Plan for National Drug Saf
NMPA Issued the Rules for Unique Identification System for Medical Devices Per the Notice of the General Office of the State Council on the Issuance of the Reform Plan for Governance over Highvalue Medical Consumables (the State Council General Office [2019] No. 37), to standardize t
Provisions for Medical Device Registration (Decree No. 4 of China Food and Drug Administration) The Provisions for Medical Device Registration, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1,
2018 Annual Report for Medical Device Registration Released On May 31, 2019, NMPA issued the 2018 Annual Report for Medical Device Registration, which consists of five parts, namely, the situation of medical device registration; the acceptance of medical device registration applica
NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration To implement the relevant policies set forth in the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deep
