Your app connects to external medical hardware to provide medical services. However, to be compliant with App Store Review Guideline 1.4.1, you must:
- Provide documentation from the appropriate regulatory organization demonstrating regulatory clearance for the medical hardware used by your app
- Provide documentation of a report or peer-reviewed study that demonstrates your app's use of medical hardware works as described
- Restrict the salable storefronts you select in App Store Connect to the regions where you have obtained regulatory clearance for the medical hardware used by your app. Otherwise, you must provide a jurisdiction statement in your app description declaring where the medical hardware has regulatory clearance to be used .
Next Steps
To resolve this issue, please provide the documentation requested above and restrict your salable storefronts in App Store Connect or include a jurisdiction statement in the app description.
Resources
Please review the App Store Review Guidelines for medical apps for more information.
Guideline 1.4.1 - Safety - Physical Harm
Your app provides medical diagnoses or treatment advice but does not include the required medical disclaimer.
Next Steps
Please revise your app's description to include a disclaimer reminding users to seek a doctor
's advice in addition to using this app and before making any medical decisions.
Once you have made the appropriate changes to your app's description, please reply to this message in Resolution Center, and we will continue with the review.
Please see attached screenshots for details.
Since your App Store Connect status is Metadata Rejected, we do NOT require a new binary. To revise the metadata, visit App Store Connect to select your app and revise the desired metadata values. Once you've completed all changes, reply to this message in Resolution Center and we will continue the review.
Because some of the indicators of blood sugar and blood pressure designed in the App are It was uploaded after being measured by the device, but it did not comply with Apple's agreement and was rejected. . .
Solution:?
Blood sugar and blood pressure related equipment are medical equipment. All those sold on the market have passed FDA certification or CFDA certification. Upload these two certificates and equipment. The manufacturer's business license is sufficient.
Regarding the disclaimer:
Just write the disclaimer as required in the application description and submit it for review. However, for those who have done ASO optimization, they may need to add disclaimers in other languages ??besides Simplified Chinese, otherwise they will still not pass.