Regulatory Compliance

ANVISA Medical Device Approval: Why Applications Fail in Brazil and How to Fix Them Fast Getting ANVISA medical device approval in Brazil can be challenging for manufacturers. Most delays happen due to classification errors, documentation mistakes, or regulatory misunderstandings.Many manufacturers assume that ANVISA approval is similar to FDA or CE Marking — and that assumption […]

Why INMETRO Certification Matters for Medical Device Manufacturers Brazil’s healthcare industry is expanding rapidly, offering enormous potential for global medical device manufacturers. However, to legally sell or distribute medical devices in Brazil, companies must comply with ANVISA and INMETRO certification requirements. The INMETRO (National Institute of Metrology, Standardization, and Industrial Quality) certification ensures that your medical devices