Hello, our app has been rejected in the review of version update, we need to provide relevant medical certificates. And our classification is Health and Fitness.However, our device is not a medical device and does not have a medical hardware regulatory license. How can I pass the audit?
“Hello,
The issues we previously identified still need your attention.
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Review Environment
Submission ID: e5e36844-23e5-41fc-a956-eb46746728c1 Review date: April 16, 2024 Version reviewed: 1.0.1
Guideline 1.4.1 - Safety - Physical Harm
The app connects to external medical hardware to provide medical services. However, to be compliant with guideline 1.4.1, you must:
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Provide documentation from the appropriate regulatory organization demonstrating regulatory clearance for the medical hardware used by the app.
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Provide documentation of a report or peer-reviewed study that demonstrates the app's use of medical hardware works as described.
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Restrict distribution of the app to regions where you have obtained regulatory clearance for the medical hardware used by the app. Otherwise, you must provide a jurisdiction statement in the app description declaring where the medical hardware has regulatory clearance to be used.
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Update the 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.
Next Steps
To resolve this issue, provide the documentation requested above, restrict your salable storefronts in App Store Connect or include a jurisdiction statement in the app description, and update your app's description in App Store Connect to include the required medical disclaimer.
Resources
Learn more about requirements for medical apps in guideline 1.4.1.
Support
- Reply to this message in your preferred language if you need assistance. If you need additional support, use the Contact Us module.
- Consult with fellow developers and Apple engineers on the Apple Developer Forums.
- Help improve the review process or identify a need for clarity in our policies by suggesting guideline changes.”
