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

#2
Hi,

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
 

Nicky

Registered
#4
Hi,

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
Hello, do you know how long will it take for shelf life change approval and coating change of injector takes. Is there any regulatory documents present for variation for different ASEAN and Middle East and Africa countries.
 
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