If One Of A Product’s Performance Indicator Values Is Formulated Based On Relevant Industry Standards,but There Is No Relevant Requirement For Such Performance Indicator In The Standard After The Industry Standard Updates, How Should The Performance Indicator Be Determined?


The value of a certain performance indicator specified in the industry standard usually represents the minimum level required in the industry and is the minimum requirement that the product should meet. In the product design and development phase, the administrative counterpart cannot rely solely on national or industry standards. When formulating relevant indicators, the administrative counterpart should analyze the indicator requirements that the product should meet in order to satisfy the intended clinical use, so as to ensure the safety and effectiveness of the product. When determining the numerical requirements of the performance indicator in combination with the product’s own structural characteristics, the administrative counterpart should be able to provide the basis to ensure that the requirements of the performance indicator are reasonable and scientific.