Apple is talking to Anvisa to regulate Watch ECG in Brazil

Apple is talking to Anvisa to regulate Watch ECG in Brazil

Last April, we informed you that it would be a long time before the electrocardiogram (ECG) Apple Watch (launched in 2018 with the Apple Watch Series 4) Brazil. This is because, for everything to be released here, Apple needs to regularize the appeal with the responsible agency (in our case, the National Health Surveillance Agency).

Last September, we found that Apple had not yet contacted Anvisa for the regularization of the ECG. Now, fortunately, that is changing.

In contact with the agency, the MacMagazine it was informed that, on November 6, the then CEO of Anvisa, William Dib, and the technical team participated in a meeting with representatives of Apple. In this meeting, the company was informed about the necessary requirements for the regularization of the ECG in the country – there are a series of state and / or municipal authorizations necessary before the national regularization.

It is important to note that, once the request for regularization of the ECG is filed, the analysis takes an average of 60 days (if all safety and efficacy requirements have been met by the company, that is).

Thus, it is likely that the Apple Watch ECG will arrive in Brazil in the first half of 2020. ?


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