Guideline for Division of Medical Device Registration Units
This Guideline is formulated according to the Provisions for Medical Device Registration (CFDA Order No. 4) and the Provisions for In-vitro Diagnostic Reagent Registration (CFDA Order No. 5). The division of registration units shall pay special attention to the product's technical principles, structure and composition, performance indicators, scope of application as well as packaging specifications of in-vitro diagnostic reagents, etc. This Guideline includes guidelines for division of registration units for active medical devices, passive medical devices and in-vitro diagnostic reagents, and lists examples for division of registration units. Some requirements shall be judged comprehensively in combination with relevant guidelines or standards for technical review of registration.
This Guideline is formulated based on the actual situation of the current medical device registration application. Along with the constant improvement of laws and regulations system, the continuous development of science and technology as well as the promotion of cognitive level, this Guideline will also be modified timely.
I. Guideline for Division of Active Medical Device Registration Units
(1) Active medical devices with different technical principles shall be divided into different registration units in principle.
(2) The same kind of active medical devices with the same technical principle but different main structures and compositions which have effect on safety and effectiveness, shall be divided into different registration units in principle.