Common Technical Issues of Active Medical Device

1. Q: Imported active medical device includes a variety of configurations when marketed in original country, but only part of the configurations was seleted when submitting in China. will it be accepted?

   A: When imported medical devices is submitted registration in China, the scope of application of the medical device shall not exceed the scope when approved in the orginal country. If only part of the configuration is submitted, and the submitted part can be applied independently and the manufacture ensures its safety and effectiveness, manufactures can make reductions on the basis of the approved scope of original country.

2. Q: when applying for registration of active products such as monitors, if the host of company A and consumables of company B are used together, is it possible to register the host and consumables together in the name of company A?

   A: (1) If the consumables of company B act on human body in an invasive way, it is recommended to register separately.

       (2) If the consumables of company B have obtained the registration certificate, and the consumables are general accessories or the registrtaion certificate indicates that they can be used with the host of company A, it is not neccessary to register the consumables with the host of company A.

      (3) If the consumables of company B have not obtained the registrtaion certificate, and the consumables fo not act on human body in an invasive way, the host and consumables can be registered in the name of company A.

      Company A shall list all consumables information used together, such as brand, name, model, specification, medical device registration certificate number (if any) in the accompanying documents of the host.

3. Q: Could non-medical device components be included in the composition components of active medical device?

   A: For the non-medical device components, they are not allowed to be submitted separately, but can be submitted as components of medical devices.

       If this components is submitted as part of the medical device, it can be considered and evaluated as part of the whole device, and it should be inspected and verified together with the whole device. if administrative counterparts does not submit this component, or does not inspect or verify the component with the whole device, then it shall not be included in the product structure composition.

      For example: printers, power supply cord, fiber optic cables for endoscope, connecting cables of neutral electrode, etc. they all belong to this situation.