Whether an IVD reagent is one of the products related to the prevention and treatment of rare diseases should be determined in accordance with documents of the Guideline for the Registration of Medical Devices for the Prevention and Treatment of Rare Diseases, Notice on the Publication of the First Catalogue of Rare Diseases, Notice of the General Office of the National Health Commission of the People’s Republic of China on Printing and Distributing the Guideline for the Diagnosis and Treatment of Rare Diseases (2019 Edition) and other documents.
If the clinical indication of the investigational reagent is a disease in the first catalogue of rare diseases, and at the same time, according to the Rare Disease Diagnosis and Treatment Guidelines (2019 edition), this assay is one of the applied detection items in the diagnosis and treatment process of the disease, the investigational reagent can be identified as a product related to the prevention and treatment of rare diseases. For the registration of the product testing a new biomarker, the intended use of the product and its relationship with the diagnosis and treatment of related rare diseases should be clarified, with which it can be determined whether the product is for the prevention and treatment of rare diseases.
According to the Provisions for In-vitro Diagnostic Reagent Registration and the relevant requirements in the Guideline for the Registration of Medical Devices for the Prevention and Treatment of Rare Diseases, positive sample size in the clinical trial can be appropriately reduced for IVD reagents that have been determined to be the products related to the prevention and treatment of rare diseases.
