Analysis on key contents for registration and application of automatic chemiluminescence immunoassay analyzer in new regulatory system / 医疗卫生装备

ABSTRACT

Objective To explore the key contents for the registration and application of the automatic chemiluminescence immunoassay analyzer in the new regulatory system to provide references to related enterprises and etc.Methods The requirements for review material,research material,product technical requirements,product specification and etc were analyzed based on the characteristics of the automatic chemiluminescence immunoassay analyzer,the requirements of newly published Provisions for Medical Device Registration as well as literature retrieval.Results Some suggestions were,put forward accordingly such as the working principle described based on reaction steps with emphases on the parts of immune reaction and optical detection.Conclusion References are provided to related enterprises when executing registration andapplication of medical devices.