Entering the Brazilian market with medical devices requires overcoming various regulatory challenges to ensure safety and compliance. While global manufacturers are often familiar with ANVISA's role in market approval, many overlook another crucial requirement—INMETRO certification. This essential conformity assessment ensures that medical devices meet Brazil’s stringent safety and performance standards and is key for gaining market access. In this blog, we’ll explore the importance of INMETRO certification for medical devices, outline the certification process, and offer best practices for manufacturers to successfully navigate this vital regulatory step.
What is INMETRO Certification?
INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia) is Brazil's National Institute of Metrology, Quality, and Technology. This government agency is responsible for establishing and enforcing safety and performance standards across various sectors. For certain medical devices, obtaining INMETRO certification is crucial to ensure compliance with Brazil's stringent regulations on quality, safety, and performance.
Understanding The Roles in Regulation of Medical Devices in Brazil : INMETRO Certification vs. ANVISA Registration
When navigating the regulatory landscape for medical devices in Brazil, it’s crucial to understand the distinct roles of INMETRO and ANVISA. Both organizations play essential roles, but they focus on different aspects of compliance and certification:
INMETRO (National Institute of Metrology, Quality, and Technology):
Affiliation: INMETRO operates as a federal agency under the Ministry of Economy.
Function: INMETRO is responsible for establishing and implementing metrology, quality, and compliance policies across Brazil.
Certification: INMETRO certification is often a preliminary requirement. It assesses whether a product meets technical specifications and safety standards but does not evaluate overall safety and efficacy.
ANVISA (National Health Surveillance Agency):
Affiliation: ANVISA is an agency under the Ministry of Health.
Function: ANVISA oversees the safety, efficacy, and quality of medical devices and other health-related products. It requires comprehensive clinical data to assess and approve products for market entry.
Certification: ANVISA certification is the final regulatory approval needed for market entry. It ensures that products meet stringent health and safety standards based on extensive clinical evaluation.
While both INMETRO and ANVISA are crucial for entering the Brazilian market, INMETRO certification typically serves as an initial step to ensure technical compliance, whereas ANVISA certification provides the final regulatory approval needed for market access.
Legal Basis for INMETRO Certification
INMETRO’s certification requirements are governed by several key regulations:
INMETRO Ordinance No. 54/2016: This ordinance, now obsolete, was previously the primary regulation guiding certification requirements.
INMETRO Ordinance No. 384/2020: Introduced in December 2020, this ordinance replaced Ordinance No. 54/2016 and outlines the current certification requirements.
Resolution 27/2011: This resolution establishes the mandatory certification procedures for various medical devices and equipment.
These regulations collectively define the standards and procedures for obtaining INMETRO certification, ensuring compliance with Brazil's safety and performance requirements.
Who Issues INMETRO Certificates?
The certification can be granted by INMETRO itself or by one of the certification bodies accredited by INMETRO. These bodies are authorized to evaluate and certify products in accordance with INMETRO’s standards.
Which Medical Devices Require INMETRO Certification?
INMETRO certification is frequently required for electrical medical devices that are subjected to IEC 60601. Moreover, some non-electrical medical devices also need INMETRO certification before they can be registered with ANVISA and introduced to the Brazilian market.
INMETRO certification is necessary for various medical devices, including:
Electro-Medical Devices: Devices that fall under ISO 60601 require INMETRO certification. The Conformity Certificate for ISO 60601 does not replace the need for INMETRO certification; it is an additional requirement.
Non-Electrical Products: Items such as needles, syringes, mattresses, gloves, breast implants, condoms, mechanical wheelchairs, handpieces, and infusion sets also require INMETRO certification.
Is INMETRO Certification Mandatory for All Medical Devices?
As outlined in Resolution 27/2011, INMETRO certification is mandatory for:
Medical, Dental, Laboratory, and Physiotherapy Equipment: This includes devices used directly or indirectly for the diagnosis, treatment, rehabilitation, and monitoring of human beings.
Beautification and Aesthetic Equipment: Devices intended for beautification and aesthetic purposes also require certification.
Devices that do not fall into these categories may be certified on a voluntary basis.
What Changed with INMETRO Ordinance No. 384/2020?
INMETRO Ordinance No. 384/2020 introduced significant changes to the certification process for medical devices in Brazil, impacting validity, renewal requirements, and inspection protocols. Here’s a breakdown of the key updates:
Certification Validity and Renewal: The ordinance has revised the timelines and procedures for the validity and renewal of certifications.
On-Site Inspections: On-site inspections are no longer mandatory and may be replaced by desktop inspections, offering greater flexibility in how compliance is assessed.
Seal Placement:
Affixing INMETRO’s Seal: Previously, manufacturers were required to affix INMETRO’s certification seal at the origin of manufacture. Under the new ordinance, manufacturers can now apply the INMETRO seal within Brazil before marketing the devices. This change simplifies the logistics and compliance for manufacturers, allowing for greater flexibility and faster market entry.
Packaging for Certain Devices: For certain disposable and non-sterile devices, the ordinance now permits the INMETRO seal to be affixed to the packaging rather than the device itself. This adjustment helps to streamline the certification process for products where labeling on the device may not be practical or necessary.
On-Site Inspections under INMETRO Certification
Under INMETRO Ordinance No. 384/2020, the requirements for on-site inspections have undergone notable changes:
Previous Requirements: Historically, on-site inspections were a mandatory part of the INMETRO certification process for medical devices. These inspections were conducted to verify compliance with INMETRO standards directly at the manufacturing facility.
Current Requirements: As of Ordinance No. 384/2020, on-site inspections are no longer universally required for all certification processes. Certification bodies now have the discretion to perform desktop audits if previous audits—conducted according to MDSAP (Medical Device Single Audit Program) or ISO 13485 standards—are deemed satisfactory. This shift aims to streamline the certification process and reduce unnecessary on-site visits.
Assessment of Production Facilities: In many cases, manufacturing is outsourced to third parties, and medical devices may have both actual and legal manufacturers. The actual manufacturer will be subject to inspection, and if there are multiple manufacturing sites involved, each site will need to undergo an inspection. If manufacturing involves multiple sites, each manufacturing location must be inspected to ensure compliance.
While the scope of on-site inspections has been adjusted to allow for desktop audits under certain conditions, initial and ongoing inspections at manufacturing facilities remain essential to ensuring compliance with INMETRO standards.
Test Reports for INMETRO Certification
With the advent of Ordinance No. 384/2020, the requirements for test reports in the INMETRO certification process have been updated. Previously, test reports were required to be issued within two years. However, under the new ordinance, test reports older than two years for small and medium-sized equipment, and those older than four years for large equipment, are now acceptable. Despite this relaxation, if any modifications are made to the device since the issuance of the original test reports, manufacturers must either conduct new testing or provide a rationale explaining why the changes do not necessitate additional testing.
For electro-medical devices, testing can be performed outside Brazil, a route often recommended. For other products such as needles and condoms, in-country testing in Brazil is required. Many international medical device companies will already have completed IEC 60601 electrical safety testing, and INMETRO typically accepts these certifications if performed by laboratories accredited by the International Laboratory Accreditation Cooperation (ILAC). All testing results must be validated by an INMETRO certifier, but meeting INMETRO's criteria can help expedite the certification process.
Process for Obtaining INMETRO Certification in Brazil
Securing INMETRO certification is a structured process that ensures your medical device meets Brazilian standards for safety and performance. Here’s a step-by-step guide to navigating the certification process:
Determine Device Classification and Certification Requirements: Start by identifying the classification of your device and understanding the specific INMETRO certification requirements applicable to it.
Engage a Brazilian Registration Holder (BRH): Appoint a Brazilian Registration Holder who will act as your representative in Brazil and manage the certification process on your behalf.
Select an INMETRO Accredited Certification Body: Choose a certification body accredited by INMETRO to conduct the necessary assessments and evaluations for your device.
Prepare Documentation: Compile all required documentation, including technical specifications and test reports, to support your certification application.
Submit the Application: File your application for INMETRO certification with the selected certification body, including all the prepared documentation.
Compliance Testing: Conduct compliance testing at CLIA (Certified Laboratory Inspection Agency) laboratories to ensure your device meets INMETRO’s technical and safety standards.
Factory Inspection and Performance Assessment: Undergo a factory inspection and performance assessment conducted by the certification body to verify manufacturing processes and product quality.
INMETRO Review and Approval: The certification body will review all submitted documentation, test results, and inspection findings. INMETRO will then grant approval if all requirements are met.
Maintain Ongoing Compliance and Recertification: Once certified, ensure ongoing compliance with INMETRO standards and prepare for periodic recertification to maintain your certification status.
Throughout this process, the medical device will undergo rigorous laboratory tests and conformity assessments to ensure it aligns with INMETRO standards or those accredited by INMETRO.
Validity of INMETRO Certificates Under Ordinance No. 384/2020
Under the previous regulations, INMETRO Certificates had a validity period of five years, requiring manufacturers to renew their certification before it expired. However, Ordinance No. 384/2020 introduced significant changes to this process.
Under the new ordinance, INMETRO Certificates no longer have a fixed expiry date. Instead, the validity of the certificate is maintained through regular audits, which must be conducted every 15 months, or at least once annually. This change simplifies the certification process by eliminating the need for certificate renewal and focusing on ongoing compliance through periodic audits.
While the INMETRO Certificate itself does not expire, manufacturers are still required to inform the INMETRO Certifier of any updates or changes to their products. The Certifier will then determine whether additional tests are needed or if an updated certificate must be issued to reflect the changes. This ensures that the certification remains current and accurate, aligning with the latest product modifications and regulatory requirements.
Key Challenges in the INMETRO Certification Process
Navigating the INMETRO certification process can present several challenges for manufacturers, particularly those new to the Brazilian market or unfamiliar with its regulatory landscape. The challenges in INMETRO Certification of medical devices may include:
Lengthy timeframes for testing and review
Complex Regulatory and documentation requirements
High costs for testing and BRH services
Keeping up with regulatory updates
Handling Multiple Manufacturing Sites
Best Practices for Achieving INMETRO Certification
Achieving INMETRO certification is a critical step for entering the Brazilian market, and adhering to best practices can streamline the process and ensure compliance. Here are some key best practices to consider:
Understand Regulatory Requirements: Thoroughly familiarize yourself with INMETRO's regulations and standards relevant to your product. This includes understanding classification, testing requirements, and documentation needs. Stay updated on any changes to regulations, such as those introduced by Ordinance No. 384/2020.
Select the Right Certification Body: Choose an INMETRO-accredited Certification Body that has experience with your type of product and understands your specific requirements. Ensure that the body is reputable and aligns with your certification needs.
Engage a Brazilian Registration Holder (BRH): For foreign manufacturers, appoint a reliable Brazilian Registration Holder to act as your local representative. The BRH will help manage the certification process, coordinate with INMETRO, and ensure that all regulatory requirements are met.
Prepare Comprehensive Documentation: Compile all necessary documentation, including technical specifications, test reports, and quality management system details. Ensure that the documentation is complete, accurate, and up-to-date. For test reports, verify that they are from accredited laboratories and reflect the current version of your device.
Conduct Thorough Pre-Inspection Reviews: Perform internal audits and reviews of your manufacturing processes and compliance with INMETRO standards before the official inspection. This proactive approach helps identify and address potential issues early.
Ensure Ongoing Compliance: Since INMETRO certificates are maintained through regular audits rather than having a fixed expiry date, establish a routine for periodic reviews and audits. Stay compliant with INMETRO standards and address any non-conformities promptly.
Handle Manufacturing Sites Effectively: If your device is manufactured at multiple locations or outsourced to third parties, ensure that all relevant sites are inspected and meet INMETRO standards. Coordinate inspections efficiently to avoid delays.
Stay Informed and Adapt: Keep up with any regulatory updates or changes to INMETRO standards. Adapt your processes and documentation as necessary to remain compliant and avoid disruptions to your certification status.
Achieving INMETRO certification is an essential step for medical device manufacturers looking to enter the Brazilian market. From testing and documentation to factory inspections, every stage must be carefully managed to ensure compliance with Brazil’s strict safety and performance standards. Starting the certification process early and understanding the distinct roles of INMETRO and ANVISA will help smooth your path to market entry.
For assistance with INMETRO certification of medical devices, feel free to contact our regulatory experts. We’ll help you ensure compliance and expedite your entry into the Brazilian market. Reach out to us at info@artixio.com for more information on how we can support your certification needs.
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