As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.
Background on clinical investigations in Brazil
Some medical devices are exempt from ANVISA approval of the study (RDC 837/2023, Article 2 (§ 1º)), including Class I and II medical devices, IVD clinical performance studies, devices already registered with ANVISA and used with the same indications and usability studies.
Clinical investigations with Class III and IV medical devices must be reviewed and authorized by ANVISA.
Brazil’s Medical Device Regulator ANVISA Announces Clinical Investigation Database | Emergo by UL
Brazil’s Medical Device Regulator ANVISA Announces Clinical Investigation Database
As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.
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