In the technical requirements for active products, how should "Product Model/Specifications and Their Division Description" be written?
According to the "Guidelines for Writing Technical Requirements for Medical Devices," the technical requirements should clearly specify the product models and/or specifications, as well as the explanation of their division. For products within the same registration unit that come in various models and/or specifications, it should clearly delineate all differences between each model and specification (if necessary, corresponding illustrations can be provided for clarification). For models/specifications with extensive descriptive text, an appendix format can be utilized. For standalone software or products containing software components, it should also specify the software's name, model specifications, release version, and the naming rules for the complete version. For control-type software components, the operating environment should also be clearly defined (including hardware configuration, software environment, and network conditions).
What should be considered for the registration units of metal bone pin products?
Metal bone pins include both fully implantable metal bone pins and those used in conjunction with external fixation frames. Metal bone pins designed for use with external fixation frames can be part of the same registration unit as the external fixation frame they are intended to be used with. This registration unit does not include fully implantable metal bone pins. Metal bone pins used with external fixation frames and fully implantable metal bone pins can be declared under the same registration unit. Guide pins used for positioning during surgery are considered surgical tools and belong to a different registration unit than internal fixation products.