,Brazil INMETRO (National Institute of Metrology, Standardization, and Industrial Quality) Certification Compliance Overview
Obtaining the Brazil-INMETRO certification is crucial for medical device manufacturers aiming to secure the National Health Surveillance Agency (ANVISA) Medical device registration in Brazil. The rigorous assessment conducted by INMETRO guarantees that the device complies with the stringent safety and quality standards set by Brazil, ensuring it meets the necessary technical specifications. This certification not only facilitates entry into the Brazilian market but also assures compliance with its regulatory requirements.
The Brazil INMETRO certification process includes an onsite assessment of the production facility for both initial certification and annual surveillance by a Product Certification Body (OCP). OCP is an INMETRO-accredited body that evaluates and certifies products to fulfill Brazil's stringent regulatory standards.
Additionally, the role of a Brazilian Registration Holder (BRH) becomes indispensable in representing foreign manufacturers’ acts a local representative for the purpose of Brazil INMETRO Certification, overseeing compliance with INMETRO's rigorous safety and quality standards specific to the product category.
Engaging with a Freyr medical device regulatory experts is strongly advised to determine the specific INMETRO certification requirements for your device. Click here to connect with Freyr's specialists.
Freyr Brazil INMETRO Certification Competencies:
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Evaluate if INMETRO certification is required based on product applicability and ANVISA’s requirement.![]()
Identify technical standards (NBRs) for device compliance and accredited laboratory to perform tests.![]()
Medical device testing in compliance with Brazil INMETRO certification requirements and ILAC accreditation.![]()
Serve as a regulatory liaison with INMETRO, managing communications and fulfilling all requirements![]()
Maintaining and renewing certification (as required)![]()
Continued compliance with Brazil INMETRO standards![]()
Provide formal training on INMETRO certification procedures, standards, and compliance best practices.
Frequently Asked Questions (FAQs)
Not every medical device in Brazil is subject to INMETRO certification; it is mandatory primarily for medical devices typically includes electro-medical devices, and some non-electro medical device such as surgical gloves, sterile syringes, and some implants.
- Obtaining an INMETRO certification varies in duration based on product type, testing complexity, documentation accuracy, and communication efficiency with testing labs and INMETRO.
- Typically, it ranges from a few months to more than a year.
- To mitigate delays, initiate the certification process well before the targeted product launch in Brazil.
- Engaging a regulatory expert who specializes in Brazil INMETRO certification can offer detailed, situation-specific advice.
- No, INMETRO certification and ANVISA certification are not the same.
- INMETRO certification focuses on technical compliance with safety and performance standards, requiring testing and documentation.
- ANVISA certification evaluates overall safety, efficacy, and quality for market approval, involving a broader review that includes clinical data.
- INMETRO certification is a preliminary technical step; ANVISA represents the final regulatory hurdle for market entry.
- Essentially, INMETRO checks the "construction" safety of the device, while ANVISA grants the "occupancy permit" for entering the market.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Independent Representation and Regulatory Support.
- Continuous Liaison with the Agency for Submissions, Queries, and Feedback.
- Single Point of Contact in the Country for Liaison with the Regulatory Agency.