2.5关于合并撰写报告2.5.1原则上，每个具有单独注册证编号的产品应

2.5 Regarding the joint writing of reports <br>2.5.1 In principle, each product with a separate registration certificate number should be written separately in the "Regular Risk Evaluation Report". If multiple specifications of the same medical device product involve multiple registration certificate numbers (for example, different specifications of single-use sterile syringes), or several products that must be used together have different registration certificate numbers (for example, hip joint system: Including acetabular cups, femoral stems, etc.), the "Periodic Risk Evaluation Report" can be jointly written if the time limit for the completion of the respective "Periodic Risk Evaluation Report" is met. <br>2.5.2 If the "Periodic Risk Evaluation Report" of the same medical device with multiple registration certificate numbers is combined, the registrant shall conduct a subgroup analysis of different products according to the registration certificate number in the report. <br>2.5.3 If the "Periodic Risk Evaluation Report" of the medical device must be combined to be used, the registrant shall note the combined product information when submitting or filing the "Periodic Risk Evaluation Report".

2.5 On the consolidation of reports<br>2.5.1 In principle, each product with a separate registration number should be separately included in the Periodic Risk Assessment Report. If multiple medical device products of the same specification involve multiple registration numbers (e.g., single-use sterile syringes of different specifications), or if several products that must be used together have different registration numbers (e.g., hip systems: including hip cups, fasc bone handles, etc.), the Periodic Risk Assessment Report may be combined to meet the time limit for the completion of their respective Periodic Risk Assessment Reports.<br>2.5.2 If the Periodic Risk Assessment Report on the same medical device involving multiple registration numbers is combined, the registrar shall conduct a subgroup analysis of the different products in accordance with the registration certificate number.<br>2.5.3 If the Periodic Risk Assessment Report for medical devices that must be used in conjunction with the WR is combined, the registrar shall note the combined associated product information when submitting or archiving the Periodic Risk Assessment Report.

2.5 report on consolidation<br>2.5.1 in principle, each product with a separate registration certificate number should write a separate periodic risk assessment report. If multiple specifications of the same kind of medical device products involve multiple registration numbers (for example, disposable sterile syringes of different specifications), or several products that must be used together have different registration numbers (for example, hip joint system: including acetabular cup, femoral stem, etc.), they can meet the requirements of the completion time limit of their respective periodic risk assessment report And write "regular risk assessment report".<br>2.5.2 if the periodic risk assessment report of the same kind of medical device involving multiple registration certificate numbers is written together, the registrant shall conduct subgroup analysis on different products according to the registration certificate number in the report.<br>2.5.3 if the periodic risk assessment report of the medical device must be combined and written, the registrant shall note the information of the associated products when submitting or filing the periodic risk assessment report.