AFE for Importers — Peticionamento Eletrônico Steps
AFE for Importers — Peticionamento Eletrônico Steps — ANVISA medical device regulation in Brazil.
Distributor's Role in Recalls & Adverse Event Reporting
Distributor's Role in Recalls & Adverse Event Reporting — ANVISA medical device regulation in Brazil.
Distributor AFE & Operating Licence Requirements
Distributor AFE & Operating Licence Requirements — ANVISA medical device regulation in Brazil.
Foreign Manufacturer Certificate (FSC)
Foreign Manufacturer Certificate (FSC) — ANVISA medical device regulation in Brazil.
GMP Equivalence — Accepting ISO 13485 for Foreign Manufacturers
GMP Equivalence — Accepting ISO 13485 for Foreign Manufacturers — ANVISA medical device regulation in Brazil.
Implant Records & Patient Traceability
Implant Records & Patient Traceability — ANVISA medical device regulation in Brazil.
Import Documentation — ANVISA Licence to Import
Import Documentation — ANVISA Licence to Import — ANVISA medical device regulation in Brazil.
Role of the Importer as Registration Holder
Role of the Importer as Registration Holder — ANVISA medical device regulation in Brazil.
Lot/Serial Number Requirements
Lot/Serial Number Requirements — ANVISA medical device regulation in Brazil.
NCM Codes for Medical Devices
NCM Codes for Medical Devices — ANVISA medical device regulation in Brazil.
Responsável Técnico — Obligation for Importers
Responsável Técnico — Obligation for Importers — ANVISA medical device regulation in Brazil.
SISCOMEX & Customs Interface for Medical Devices
SISCOMEX & Customs Interface for Medical Devices — ANVISA medical device regulation in Brazil.
SNVS Supply Chain Traceability Initiatives
SNVS Supply Chain Traceability Initiatives — ANVISA medical device regulation in Brazil.
Storage & Transport Conditions
Storage & Transport Conditions — ANVISA medical device regulation in Brazil.
Brazil Traceability System — Current Status & Roadmap
Brazil Traceability System — Current Status & Roadmap — ANVISA medical device regulation in Brazil.
ANVISA UDI Alignment with IMDRF Framework
ANVISA UDI Alignment with IMDRF Framework — ANVISA medical device regulation in Brazil.