It should have the appropriate production capacity before the record, but this production capacity is mainly to see the record unit of some hardware conditions, such as the production process related to the overview of the situation. Passive medical devices should be clear product production process, indicating the key processes and special processes. Active medical devices should provide descriptive information on the production process of the product, which can be in the form of flow charts, an overview of the production process. In vitro diagnostic reagents should be an overview of the main production process, including: description of the solid phase carrier, color development system and other basis for determining the reaction system including sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration methods (if necessary), quality control methods.
The actual situation of the development and production site should be summarized.
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