Medical device registration management measures (revised draft) "Article XIII inside a clear description.
Article XIII determines the medical device registration unit, should be based on the technical structure of the medical device product, performance indicators and intended use and other circumstances for comprehensive determination.
Made by the same manufacturer, the design and production process, intended use are the same, only the shape, color, smell or size of the medical device is different, can be used as a unit of registration; to meet the specific needs of the medical device package packaged together can be used as a unit of registration; several medical devices to achieve some or all of the intended function of the medical device system can be used to achieve some or all of the intended function, can be used as a unit of registration. as a unit of registration.
Registered medical devices can be sold separately if the components listed in the "Performance Structure and Composition" column of the medical device registration certificate are used in the original combination and for the original purpose.
For example, a series of products of the same class can be used as a registered unit.