Author name: Pratiksha

ANVISA medical device approval

Why Medical Device Approvals Fail in Brazil (ANVISA) And How to Fix Them Fast

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 […]

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Dental Scanners Regulation Process

Dental Scanners Regulation Process in Brazil: A Complete Compliance Guide (2025)

Medical Device Manufacturing /

Dental Scanners Regulation Process: Ensuring Regulatory Compliance in Brazil Bringing a dental scanner to the Brazilian market requires more than innovative technology—it demands strict adherence to the Dental Scanners Regulation Process defined by national and international regulatory authorities. Without proper compliance, even the most advanced digital dental scanner cannot be legally marketed or used in

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Surgical Bandage Manufacturing Plant

Successful Surgical Bandage Manufacturing Plant Setup in Brazil (2025 Guide)

Medical Device Manufacturing /

Introduction Surgical Bandage Manufacturing Plant setup in Brazil represents a fast-growing and profitable opportunity in the country’s booming medical device industry. With a thriving healthcare infrastructure, rising demand for disposable medical consumables, and increasing surgeries in cities like São Paulo, Rio de Janeiro, and Porto Alegre, investing in this sector can bring both financial stability

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INMETRO Certification for Medical Devices

INMETRO Certification for Medical Devices in Brazil – A Complete Guide

Regulatory Compliance /

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

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medical device registration in Brazil

Medical Device Registration in Brazil – Complete ANVISA Approval Guide

Medical Device Manufacturing /

Introduction to Medical Device Registration in Brazil Medical device registration in Brazil is essential to ensure that medical products meet safety, quality, and performance standards before entering the market. The Brazilian Health Regulatory Agency (ANVISA) regulates all medical devices in Brazil, including in vitro diagnostic (IVD) devices. Registering a medical device with ANVISA is a

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