Medical network - on February 9, recently, the state food and drug supervision and administration bureau released the amendment to the in vitro diagnostic reagents registration measures for the administration, will the registration measures for the management of in vitro diagnostic reagents (state food and drug supervision and administration of administration makes no. 5), paragraph 1 of article 20, the original "state food and drug supervision and administration bureau shall be responsible for in vitro diagnostic reagents product classification catalogue shall be formulated and adjusted", is amended as: "article 17 and 18 of this regulation, mentioned in article 19 of the classification rules in vitro diagnostic reagent, used to guide the formulation and adjustment of the catalogs of in vitro diagnostic reagent, and determine the type of the new management of in vitro diagnostic reagents. The state food and drug administration bureau may vary according to the risk of the in vitro diagnostic reagents, adjustments to the classification rules." Amendment come into force from the date of release.

In 2014, the food and drug supervision bureau issued a "registration measures for the management of in vitro diagnostic reagent, the article 17, article 18 and article 19 has been clear about the classification rules in vitro diagnostic reagent, used to guide the formulation and adjustment of the catalogs of in vitro diagnostic reagent, and determine the type of the new management of in vitro diagnostic reagents.

In recent years, with the development of in vitro diagnostic technology, the increase in the use, in accordance with the "measures for the administration of registration of in vitro diagnostic reagent", article 17, article 18 and article 19 classifying in vitro diagnostic reagent, the classification of some products don't match with its risk, such as for the diagnosis of tumor, immunohistochemical class in vitro diagnostic reagent inspection result is only one provide the reference for the doctor, the doctor will also need to consider other indicators a large number of diagnostic tests to diagnose, but according to the above terms, any associated with tumor assisted diagnosis in vitro diagnostic reagents is managed as a class iii medical devices and some unreasonable classification. Due to the above terms content lack of adjustment of space, make relevant adjustment and risk of product categories do not match, can't adapt to the medical device regulatory requirements.

This amendment clearly state food and drug supervision and administration of administration can vary according to the risk of the in vitro diagnostic reagent, adjust classification rules, adjust the leaving space for future classification rules and directory. The future work, the state food and drug supervision and administration of taxation will be in strict accordance with the requirements of the regulations on the supervision and administration of medical devices, based on the risk of in vitro diagnostic reagent, the full demonstration, for public opinion on the basis of the research, carried out classification rules and adjustment of catalog work, the management category of in vitro diagnostic reagents is more scientific, reasonable, and further promote the reform of medical apparatus and instruments for examination and approval of the review, and to adapt to the medical device industry development in clinical use and regulatory requirements.