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巴西ANATEL:您的器械是否需要?

英语音频 · 1:47

了解互联医疗器械何时可能需要在巴西获得ANATEL无线电型号核准,以及该流程涉及的具体环节。

文字稿(英语)

Does your device need ANATEL? If it has Bluetooth, Wi-Fi or another radio, it generally needs ANATEL homologation, separate from ANVISA. And since September, requests use a new system. Certification runs through a designated body, an OCD. A lab tests a sample, the OCD issues a certificate of conformity, and ANATEL then grants homologation. The applicant must be a Brazilian company or resident, such as a foreign maker's commercial representative. The homologation certificate itself is free. Since September 8, 2026, new requests go through ANATEL's Certifica system. And by default the certificate has no end date, as long as required maintenance continues. One trap: the homologation code belongs to its holder. ANATEL says only the holder may use it. Moving it later takes a new certificate, so decide before you file. Start with three things. One: list every radio in the device. Two: choose the Brazilian company that will hold the certificate. Three: file the ANATEL certificate with your ANVISA dossier. No homologation, no sale in Brazil. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.

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