Overview Brazil is one of the biggest countries in South America and Latin America. It spends hugely on healthcare boosting the Medical Devices locally. The country has established regulations in place and it governs Medical Devices through National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) under Ministry of Health. The registration is done through Cadastro or Registro processes basing on the device classification (Class I, II, III and IV) which also decides the extent of scrutiny involved for approval. Further, all the medical device manufacturers need to comply with Brazilian Good Manufacturing Process (BGMP) which is in lines with ISO 13485. The complex, stringent and extensive Regulatory regime makes the process daunting. Freyr assists manufacturers to identify the Device Classification as a first step. Freyr helps clients in procuring certifications such as INMETRO and BGMP by helping in rectifying the Regulatory hassles involved. With proven expertise in launching numerous devices in the region, we offer end-to-end Regulatory services for Medical Devices. Freyr Expertise Medical Device Classification Brazil Local Representation Regulatory Support to acquire Brazilian Good Manufacturing Process (BGMP) Certification Support for Procuring INMETRO Certification Document Compilation for Cadastro and Registro Processes Post-market Surveillance Brazil Market Entry for Medical Devices - Process Flow Summary S. No Requirement Brazil 1 Regulatory Authority Agência Nacional de Vigilância Sanitária (ANVISA) 2 Regulation RDC 185/2001 3 Risk Classification Class I Class II Class III Class IV 4 Regulatory Pathway Class I & II Cadastro Class III & IV Registro 5 Authorized Representative Authorized Representative required 6 Fee payable $1000 - $12,500* 7 QMS Requirement Brazilian GMP / MDSAP 8 Assessment of Technical Data ANVISA 9 Validity of License Cadastro Perpetual Registro 5 Years 10 Labelling Requirements Annex III.B of RDC 185/2001 11 Submission format Paper & Electronic 12 Final Outcome Registration number in DOU 13 Timelines Cadastro 1 - 3 Months Registro 9 - 15 Months 14 Language Brazilian Portuguese/English *The price is as per records at the time of documentation and is subject to change.