The Study Of Assessment Index System For Market Access Of In Vitro Diagnostic Reagent

Developing rapidly, the In Vitro Diagnostic Reagents (IVDs) plays a more and more important role in medical practices, such as physical examination, disease diagnoses, curative effect evaluation, prognosis, and so on. The quality and diagnostic value of IVDs becomes the focus point of medical agency and the public. So, for the safety of people's health, we need to strengthen the management of IVDs market access to make sure that only the IVDs with high quality can be approved to the market. As far as we know, Being the key step of market access management, the IVDs market access evaluation still lacks a technical assessment index system presently. Therefor, in this study we try to establish an assessment index system for market access evaluation of IVDs.Using Informatics and soft science methods, we systematically analyzed the characters of IVDs, the factors that effect the quality of IVDs, and the regulations of IVDs market access at home and overseas. According to the principle of designing an assessment of index system, we tabled an indexe system on two levels, which include 4 indexes at the first level and 10 indexes at the second level on the basis of Delphi. Further more, we adopt Rank Sum Ratio method (RSR) to decide the weight of indexes. Being inspected in simulative evaluation, the system is proved to be scientific and feasible, and it would be a good help to the medical administration organizations in the assessment of IVDs for market access.