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Medical devices_hong kong_post approval changes regulation (China's MOH)


If the change/s in the product leads to the below points these are reported to authorities, authorities study these changes may recommend the changes dependently.
  • A change in indications for use from prescription use to over the counter use
  • Addition of a new patient population
  • Changes to the environment of use such as from professional use to home use or hospital use to ambulatory transport
  • Changes in frequency or duration of use
  • Change to indicate compatibility with a type of device, component, or accessory that was not indicated as compatible with the previously cleared device
  • Changes in sterilization, cleaning or disinfection
  • Changes in package integrity or shelf-life claims
  • Changes in device design
  • Changes to employ wireless communication
  • Changes in the human factors of the patient or user interface
  • A change in material type, formulation or chemical composition
  • Changes in the antibody, detection reagents, critical reaction components or conjugates for in vitro diagnostic (IVD) devices
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