INMETRO certification is fundamental to ensuring that products and services comply with quality and safety standards in Brazil. This process is especially crucial for medical devices, which must meet strict standards to ensure user safety.
Before delving into the certification workflow, we recommend you check out the article “Compliance in Focus: How to Identify the Need for INMETRO Certification for Medical Devices“. This article provides valuable insights on how to identify the need for INMETRO certification for medical devices, highlighting regulatory requirements and the benefits of ensuring compliance.Below is a step-by-step guide to the process, including possible feedback in case of issues:
- Identification of Certification Need
Objective: Identify which products or services need certification.
- Consultation of Standards and Regulations:
- INMETRO Website: Visit the official INMETRO website and look for information on regulations and certification. The regulation section contains a list of products that require certification.
- INMETRO Ordinances: Check the ordinances published by INMETRO that establish certification requirements for different product categories.
- Product Category Identification:
- Specific Product: Identify the specific category of your product. INMETRO regulates a wide range of products, including household appliances, toys, personal protective equipment, medical devices, among others.
- Technical Standards: Consult the technical standards related to your product to verify if certification is required.
- Consultation with Certification Bodies:
- Accredited Certification Bodies: Contact certification bodies accredited by INMETRO. They can provide guidance on the need for certification and the steps to follow.
- Consultation of Specific Legislation:
- Departament Legislation: Some regulations may be specific to certain sectors. Check if there is departament legislation that requires INMETRO certification for your product.
- Verification of Similar Products:
- Analysis of Similar Products: Check if products similar to yours in the market have INMETRO certification. This can be an indicator of the need for certification for your product.
- Technical Advisory:
- Specialized Consulting: In case of doubt, it is advisable to seek specialized technical and legal advice on product regulation to ensure all requirements are met.
- Examples of Products Requiring INMETRO Certification:
- Household Appliances: Refrigerators, stoves, washing machines, among others.
- Toys: All toys sold in Brazil.
- Medical Devices: Diagnostic equipment, blood pressure monitors, thermometers, among others.
- Personal Protective Equipment (PPE): Safety helmets, gloves, boots, etc.
Action: Assess whether the product/service impacts consumer safety or health.
- Selection of an Accredited Certification Body
Objective: Select the best certification bodies accredited by INMETRO. Here at Brisa Advisors, we have partnerships and excellent relationships with certifiers who serve us faster and provide better support.
Action: Choose an organization with experience in the specific type of product or service.
- Preparation of Documentation
Objective: Assist in organizing all the necessary documents for certification.
Action: Gather technical specifications, test reports, and other relevant information.
- Certification Request
Objective: Formalize the certification request.
Action: Fill out forms and pay fees associated with the process.
- Initial Evaluation and Compliance Testing
Objective: Verify the compliance of the product or service with INMETRO requirements.
Action: Conduct laboratory tests and performance checks.
If non-compliance: Return to the Documentation Preparation stage for necessary adjustments.
- On-Site Production Audit (when applicable)
Objective: Ensure that manufacturing processes meet quality standards.
Action: Conduct an audit at the factory or production site.
If issues in the audit: Return to the Initial Evaluation and Compliance Testing stage for correction.
- Analysis of Results and Final Report
Objective: Review the results of tests and audits.
Action: Issue a final report with the certification decision.
- Issuance of the INMETRO Certificate
Objective: Formalize that the product or service meets the required standards.
Action: Issue the official INMETRO certificate.
- Maintenance and Renewal of Certification
Objective: Ensure that the certification remains valid over time.
The validity of the conformity certificate is usually three years but may vary depending on the type of device and specific applicable regulations. After the validity period ends, a new certification process is required to renew the certificate.
Action: During the validity period of the certificate, it is common for the manufacturer or importer to undergo follow-up audits to ensure that the device continues to comply with regulatory requirements.
If not renewed: Return to the Issuance of the INMETRO Certificate stage to start a new cycle.
📑 Learn More
For a deeper understanding of how the certification process can benefit your company, ensure consumer safety, and for more information on the certification of medical devices, contact the specialists at Brisa. They are ready to help with your questions and guide you through the certification process.
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