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 meet Brazil’s safety, performance, and quality standards. This certification is a key component of ANVISA’s regulatory approval process, and without it, your devices cannot enter the Brazilian market.
Read More: ANVISA Medical Device Registration
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What is INMETRO Certification?
INMETRO certification verifies that a medical device conforms to Brazilian technical regulations for safety, quality, and performance. It focuses on the product’s electrical safety, mechanical reliability, and compliance with ISO and IEC standards applicable to the device category.
INMETRO works under the Ministry of Development, Industry, and Foreign Trade (MDIC) and collaborates with ANVISA to ensure that all imported and locally manufactured medical devices are safe for clinical and patient use.
Medical Devices Requiring INMETRO Certification
INMETRO certification typically applies to electrically powered and electromedical devices, including:
- Patient monitors and ECG machines
- Infusion and syringe pumps
- Ventilators and anesthesia machines
- Diagnostic imaging equipment (X-ray, MRI, ultrasound)
- Laboratory and testing equipment
- Electrosurgical and therapeutic devices
Note: Non-electrical medical devices may not require INMETRO approval but still need ANVISA registration for commercialization.
Step-by-Step Process for INMETRO Certification of Medical Devices
- Device Classification and Standard Identification
Determine whether your product requires INMETRO certification and identify applicable Brazilian technical standards (NBR IEC 60601, ISO 13485, etc.).
- Appoint a Local Brazilian Representative
Foreign manufacturers must have a Brazilian Registration Holder (BRH) or authorized local representative to coordinate the certification and ANVISA registration process.
- Select an Accredited Certification Body (OCP)
Choose an INMETRO-accredited certification body (Organismo de Certificação de Produto – OCP) to conduct the assessment and testing.
- Product Testing and Factory Audit
- Devices are tested in INMETRO-accredited laboratories to verify compliance with Brazilian standards such as NBR IEC 60601 and other applicable technical regulations.
- If the manufacturer already has valid test reports that comply with INMETRO requirements and Brazilian standards, these reports may be accepted, avoiding the need for repeated testing.
- Factory audits are conducted to verify compliance with ISO 13485:2016 or an equivalent Quality Management System (QMS).
- An audit of the local Brazilian applicant (Brazilian Registration Holder or distributor) is also required as part of the conformity assessment process.
- Technical Evaluation and Report Submission
The certification body reviews test results and audit reports. If all criteria are met, it issues the INMETRO Certificate of Conformity. - INMETRO Labeling and ANVISA Submission
Once certified, the product must carry the INMETRO mark and the certification body’s logo.
This certification is then used as part of the ANVISA device registration dossier. - Certificate Maintenance and Renewal
- For electromedical and electrical medical devices, as per INMETRO Resolution Ordinance 384/2020:
Certification has indeterminate validity (no expiration date).
However, certificate maintenance must be performed every 15 months, which includes surveillance audits and periodic analysis to ensure continued compliance.
- For non-electrical medical products (e.g., syringes, needles):
Certification validity is typically 3 years, with annual surveillance audits.
- For electromedical and electrical medical devices, as per INMETRO Resolution Ordinance 384/2020:
Benefits of INMETRO Certification for Medical Device Companies
- Market Access: Gain entry into Brazil’s regulated and high-demand healthcare market.
- Regulatory Compliance: Demonstrate conformity with ANVISA and INMETRO safety standards.
- Enhanced Credibility: Build trust with hospitals, clinics, and distributors through certified quality.
- Global Recognition: Align with IEC and ISO frameworks, supporting approvals in other markets.
- Improved Product Safety: Validate performance and minimize device-related risks.
Want to certify your medical device under INMETRO and access Brazil’s healthcare market?
How Operon Strategist Helps with INMETRO Certification
Operon Strategist provides end-to-end consulting support for INMETRO certification and ANVISA registration of medical devices in Brazil. Our experts assist with product classification, coordination with INMETRO-accredited bodies, technical file preparation, factory audit readiness, and labeling compliance.
With deep regulatory expertise, we help manufacturers simplify certification, reduce approval time, and enter the Brazilian market confidently.
Other Services We Offer:
Along with INMETRO certification, Operon Strategist also provides:
- CE Marking Consulting (EU compliance under MDR)
- US FDA 510(k) Submission Support
- ISO 13485 Implementation & Certification Assistance
- MDSAP Consulting for multi-country regulatory compliance
- GMP Facility Layout Design & Validation Services
Partner with us to ensure your medical device meets global regulatory standards and gains faster market access.
FAQs
Is INMETRO certification mandatory for all medical devices in Brazil?
No. INMETRO certification is mandatory mainly for electrical and electromedical devices that pose safety risks. Other devices still require ANVISA registration.
Can foreign manufacturers apply directly for INMETRO certification?
No. You must appoint a local Brazilian representative to liaise with INMETRO and certification bodies.
How long does the INMETRO certification process take?
The timeline varies by device type but typically ranges from 3 to 6 months, depending on testing complexity.
What is the validity period of INMETRO certification?
It’s valid for 3 years, with annual surveillance audits to ensure continued compliance.
Does INMETRO certification automatically mean ANVISA approval?
No, but it’s a mandatory prerequisite for ANVISA registration of applicable medical devices.