Dear Apple, who is responsible for applying for registration of the APPLE Watch ECG as Medical Device Class IIa in any country? Is it APPLE or its representative office in specific country of Government of specific country?
Apple Watch Ultra 2, watchOS 11
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Historically, it has generally been the country's health agency/department/ministry/... that has been the hold up.
Although in Australia it was the way the law was written, and until the law was changed, Apple Watch ECG was not available in Australia (which annoyed the country's users to no end, and created all kinds of wrong information to be circulated).
And sometimes it is politics, because the U.S. government has banned U.S. companies from doing business in specific countries.
Apple Watch ECG Registration as Medical Device
