To take advantage of these opportunities, manufacturers and suppliers must ensure their products meet the requirements laid down by the National Health Surveillance Agency – ANVISA.
Medical devices must be tested for quality, safety and efficacy before they can be offered onto the Brazilian market. To ensure this, ANVISA has introduced a set of mandatory requirements based on the European Union model. Before a product reaches the market, it must be certified as conforming to these requirements by a certification body accredited by CGCRE – General Coordination for Accreditation of INMETRO.
How Does ANVISA Define Medical Devices?
Under Resolution RDC Nr 27, issued June 21, 2011, medical devices are defined as equipment, including parts and accessories, for medical, laboratorial or physiotherapeutic purposes. They can be used either directly or indirectly for diagnosis, treatment, rehabilitation or monitoring, and it includes equipment for beauty and aesthetic purposes.
Manufacturers and suppliers also need to consider ANVISA’s Normative Instructions – Nr 04, Nr 22 and Nr 29. These rules bring together all applicable standards that must be considered to state whether a product is eligible for certification. They also include the deadline from which certification becomes mandatory.
Examples of products for which certificates are requested:
- Diagnostic equipment
- Therapy equipment
- Medical-hospital support equipment
- Disposable materials and devices
- Medical-hospital support materials and devices
- Beauty and aesthetics devices
- Motorized and manual wheelchairs
It is worth noting ANVISA makes the ultimate decision on CGCRE certification.
ANVISA has developed two routes to ANVISA approval – cadaster and registration. Cadaster is simpler and faster for lower-risk devices, but both routes require similar documentation.
ANVISA approval is via a Good Manufacturing Practice (GMP) audit. Performed directly by ANVISA, it must be completed before registration submission, as certification is a pre-requisite for some products. Products must be classified before registration to determine if a GMP audit will be required.
CGCRE Certification Process
Medical devices covered by any standard included in Normative Instructions Nr 04, Nr 22 and Nr 29, considering their respective deadlines, must be certified by an Organization of Certification of Product (OCP) and display the INMETRO mark.
Certification confirms the quality of a system, process, product or service. This is achieved through the evaluation and review of compliance with specified requirements, technical standards and technical regulations. All processes are defined in ORD54, issued by INMETRO on February 1, 2016, which has completely superseded ORD350 since April 2018. Certificates issued in accordance with ORD350 remain valid until their expiration date unless there is a significant change, in which case they must be certified to ORD54.
The current evaluation mechanism used by Product Certification Bodies (PCB) to issue the compliance certificate can be summarized in the following steps:
- Initial assessment: formal request to the PCB of the product with the minimum documentation
- Initial factory inspection: focus ISO 13485 clauses and routine tests, according to clauses 8.6, 8.7 and 8.8 of IEC 60601-1. Conducted on 100% of products bearing INMETRO mark. There is additional request to validate the requirements of IEC 60601-1-6, IEC 60601-1-9, IEC 62304 and ISO 14971 during audits
- Test reports: issued only by laboratories accredited by members of ILAC, IAAC or EA according to all applicable IEC standards. Reports must be issued no more than 2 years ago, or 4 years ago for big size products, considering the date of initial certification process and must be redone upon renewal
- Factory inspections: must be performed every 15 months to maintain certification – four audits in five year certification period of validity
- Imported products: Brazilian local representative inspected to check compliance with the requirements of ORD54 (customer complaints, traceability control of the products bearing the compliance seal, product preservation, etc.). Performed every 15 months
Brazil uses international standards, adapted to local requirements, to guide their rules. The transition to the third edition of the series of standards IEC 60601-X has the commitment from all sectors. However, although there are some deadlines to consider according to ANVISA, while no Brazilian laboratories can conduct tests according to the third iteration, test reports according to the standards in the second edition are accepted.
Stakeholders should be aware ORD54 requires harmonization with the third edition of the IEC60601 standards and there will be an impact on document analysis and factory inspections.
- Import controls – customs agents check medical devices at the border against ANVISA databases to ensure compliance
- Monitoring certification – periodic audits are performed on factories and suppliers to ensure continued compliance of product and processes, for medical electrical equipment certification. NB. design changes instigated during the five-year period of validity must be ported and approved in advance
- Local representation – to sell in Brazil, manufacturers must have a local representative within the country who acts on behalf of the supplier in all product-related matters
SGS has over 70 years’ experience of working in Brazilian markets. Our expertise in compliance management lets us deliver fully CGCRE-accredited, independent and innovative services to the medical device sector using our state-of-the-art facilities. We provide tailor-made services with rapid turnaround times, value-based pricing, technical assistance and key account management.
To learn more about SGS’s CGCRE certification services contact your local SGS representative or contact our global team at email@example.com.
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