On March 7th, the Brazilian National Health Surveillance Agency (ANVISA) published Technical Guidance Note 002/2018/GQUIP/GGTPS/ANVISA, requiring submission of a copy of the valid ANATEL approval certificate for telecommunications modules in medical devices and/or respective accessories equipped with telecommunication features, such as wireless communication modules (e.g. Bluetooth, Wi-Fi, cell phone interface, etc.), at the time of submitting new products to registration, filing and/or amendments under this purpose, in compliance with ANATEL Resolution No. 680, dated June 27th, 2017, or replacements thereto.
It is important to note that the Technical Guidance Note establishes ANATEL’s approval of telecommunication modules in medical equipment and devices equipped with telecommunication features as a minimum criterion to register and/or update registries at ANVISA.
Accordingly, medical devices which are under registration analysis, in accordance with RDC Resolution No. 56, dated April 6th, 2001, and for which approval of the respective modules has not been submitted, are subject to demands for compliance by ANVISA.
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Please refer to Technical Guidance Note 002/2018/GQUIP/GGTPS/ANVISA for more details on the changes!