II. For Class II and Class III medical device products that have been in the first registration cycle on January 1, 2019, the registrant shall also make up for the submission of the 2019 annual periodic risk evaluation report before September 30th.
Third, in the first registration cycle of the product periodic risk evaluation report writing cycle for once a year, the data summary start date (month, day) with the approval of the time of registration documents.
Four, with reference to the management requirements for Class II and Class III medical devices, Class I medical devices to obtain the record certificate for the first five years after the annual writing of periodic risk evaluation reports, and then do not need to write periodic risk evaluation reports.
Fifth, if more than one specification of the same medical device product involves more than one registration number (such as, different specifications of single-use sterile syringes), or must be used in conjunction with several products with different registration numbers (such as, hip system: including acetabular cups, femoral stalks, etc.), to meet the requirements of their respective time limit for completion of the periodic risk assessment report, can be combined to write the periodic risk assessment report. The periodic risk evaluation reports can be combined if the timeframe for completion of the respective periodic risk evaluation reports is met. If the reports are combined, the information of the combined products should be noted when the reports are submitted or filed. For similar products, if combined, the report also needs to be analyzed by subgroup according to the registration number