Medical Devices
【Update Date:2022-07-07】unit:醫療器材及化粧品組
The technical document should involve the product’s structure, material(s), specifications, performance, intended use, drawing, etc. Documents could also be drafted in the form of exploded-view drawings, block diagrams, or skeleton diagrams.
Instruments and equipment: Documents relevant to every model and accessories should be enclosed. Alternatively, the operation manual and maintenance manual that cover these documents may replace them.
Consumables: For products that belong to the same type (same structure and composition) but only differ in dimensions/size/scale, it is allowed to simplify the kind of documents that conform with the representative model. Notably, for those products whose parts contact the human body, a table showing the composition and materials should be enclosed, and the contents of the table should include a corresponding skeleton diagram.