Implementation instructions for regular risk assessment report of adverse events of medical devices

Implementation instructions for regular risk assessment report of adverse events of medical devices


Source: national food and drug administration drug evaluation center May 11, 2020 09:54


Must be approved by the state drug administration and supervision of medical equipment, on the basis of the medical device adverse event monitoring and evaluation measures for the administration of state administration makes no. 1 (market) (hereinafter referred to as the "method"), the center for the first time to write and submit medical apparatus and instruments of risk assessment on a regular basis time and scope of summary data to do the following instructions


A description of the problems related to the implementation of regular risk assessment report on adverse events of medical devices





Released May 6, 2020




Must be approved by the state drug administration and supervision of medical equipment, on the basis of the medical device adverse event monitoring and evaluation measures for the administration of state administration makes no. 1 (market) (hereinafter referred to as the "method"), the center for the first time to write and submit medical apparatus and instruments of risk assessment on a regular basis and scope of data summary as follows:




The registrants of category I, ii and iii medical devices shall submit the annual periodic risk assessment report in 2020 according to the requirements of the measures. Those who should submit the report earlier than September 30 in 2020 May submit the report before September 30 at the latest.




Ii. For category ii and category iii medical device products that are already in the first registration cycle on January 1, 2019, the registrant shall submit the 2019 annual periodic risk assessment report before September 30.




Iii. For products in the first registration cycle, the regular risk assessment report shall be written once a year, and the data collection starting date (month, day) shall be consistent with the time when the registration certificate is approved.




Iv. According to the management requirements for category ii and category iii medical devices, the first category medical device shall write a regular risk assessment report every year for the first five years after obtaining the filing certificate, and it is not necessary to write a regular risk assessment report after that.




Five, if multiple specifications of the same medical equipment products involving multiple registration number (e.g., different specifications of the disposable use asepsis injector), or must cooperate with the use of several products have different registration number (for example, hip system: including the acetabulum cup, the femoral handle, etc.), in meet the requirements of respective time limit to complete risk assessment on a regular basis, can be combined to write risk assessment on a regular basis.

If written in combination, the related product information written in combination shall be noted when the report is submitted or filed.

For similar products, if they are combined, sub-group analysis should be carried out according to the number of the registration certificate in the report.


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