首次获得批准注册的医疗器械，注册人应当在每满1年后的60日内完成上年度

For medical devices that are approved for registration for the first time, the registrant shall complete the previous year's regular product risk assessment report within 60 days after every 1 year. <br><br>For the second and third categories of medical devices that have been renewed registration, the registrant shall complete the Periodic Risk Assessment Report for this registration cycle at the next renewal application, and the registrant shall keep it for future reference. <br><br>The "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events" will come into effect on January 1, 2019

For medical devices that have been approved for registration for the first time, the registrar shall complete the periodic risk assessment report of the previous year's product within 60 days after each year.<br><br>For medical devices of the second and third categories of renewal registration, the registrar shall complete the Periodic Risk Assessment Report of the current registration cycle at the time of the next renewal of registration application and shall be retained by the registrar for inspection.<br><br>The Measures for the Monitoring and Re-evaluation of Adverse Events in Medical Devices will come into effect on January 1, 2019

For the medical devices approved for registration for the first time, the registrant shall complete the periodic risk assessment report of the previous year within 60 days after each year.<br>For the class II and III medical devices that have obtained the renewal registration, the registrant shall complete the periodic risk assessment report of this registration cycle at the next registration extension application, and the registrant shall keep it for future reference.<br>The management measures for monitoring and re evaluation of adverse events of medical devices shall be implemented from January 1, 2019