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In an increasingly competitive market, organisations around the world are investing in optimisation and continuous improvement of their operations in order to surpass the competition.

Medical devices distributed and/or sold in Brazil must comply with regulations from the National Health Surveillance Agency (ANVISA) and the National Institute of Metrology, Quality and Technology (INMETRO).

SGS gives organisations the ability to achieve these twin goals of optimisation and continuous improvement. As one of the world’s leading inspection, verification and certification companies, SGS is an accredited Certifier in Brazil, appointed by the General Coordination for Accreditation of INMETRO (CGCRE). In addition to our global expertise, we also work with local resources to deliver all support and services needed by medical device manufacturers and importers.

In Brazil, certification is one of the requirements considered before products can be granted registration for commercialisation by ANVISA. CGCRE accredited bodies can complete product assessment and award certification, and the right to display the INMETRO mark. Certified products must then display the INMETRO mark. It is mandatory and is a guarantee that a product meets the country’s quality, safety and efficacy requirements.

It is important to know that the certification process is intended primarily to inform and protect consumers, particularly with regard to health, safety and the environment. In addition, product certification seeks to promote fair competition between manufacturers and encourage continuous quality improvements in products. Globally, certification provides adequate controls with regard to international trade, while at the same time strengthening Brazil’s internal market.

How does ANVISA Define Medical Devices?

Resolution RDC Nr 27 issued by ANVISA on 21 June 2011 – defines that the equipment (including parts and accessories) under sanitary surveillance are those for medical, dental, laboratory, or physiotherapeutic purposes, used directly or indirectly for diagnosis, treatment, rehabilitation and monitoring of human beings, as well as equipment for beauty and aesthetic purposes. Another rule that must be considered in deciding whether or not a product needs certification is Normative Instruction Nr 11, issued by ANVISA on 16 December 2014. This rule brings together all the standards that must be considered to state whether the product is eligible or not for certification, and also the deadline for the cases where the certification is not yet mandatory.

Nevertheless, manufacturers can share this task with an Organisation of Certification of Product (OCP), such as SGS. We are accredited as an OCP by CGCRE (the Brazilian Authority for accreditation of product certification bodies) to issue certificates. We can also issue declarations to confirm that a product does not fall within the scope of the certification scheme.

Below are some examples of products for which certification is mandatory:

  • Diagnostic equipment
  • Therapy equipment
  • Medical-hospital support equipment
  • Disposable materials and devices
  • Medical-hospital support materials and devices
  • In-vitro diagnostic products (certification process not mandatory)
  • Beauty and aesthetics devices
  • Motorised wheelchairs

It is worth noting that ultimately, ANVISA defines exclusions from CGCRE certification.

How Does The Certification Process Works?

Regulatory compliance

It is important to remember that medical devices intended for sale in Brazil must have prior approval from ANVISA. ANVISA has developed a set of essential requirements for medical device compliance, which gives two routes to ANVISA approval: cadastre and registration. Cadastre is the simpler and faster option for lower-risk devices, but both Cadastre and Registration require similar documentation.

The approval process is completed via a GMP audit that is performed directly by ANVISA. This must be done before the registration submission, because for some products a GMP certificate is a pre-requisite. Therefore, it is necessary to first classify the class of risk of the product for registration to determine whether or not a GMP certificate/audit will be required.

CGCRE Certification Process

Medical devices covered by any standard included in the Normative Instruction Nr 11, considering the respective deadline, must be certified by an OCP and display the INMETRO mark.

The certificate demonstrates the quality of a system, process, product or service, through an evaluation and review of compliance with specified requirements, technical standards and technical regulations. All processes are defined in ORD 350, issued by INMETRO on 6 September 2010. The current evaluation mechanism used by OCPs to issue the compliance certificate can be summarised in the following steps:

  • Initial assessment: the applicant submits to the OCP a formal request for the product that will be certified, with the minimum documentation required
  • Initial factory inspection focusing on ISO 13485 clauses and routine tests, in accordance with clauses 18, 19 an 20 of IEC 60601-1 and conducted on 100% of products bearing the INMETRO mark
  • Test reports must be issued by laboratories accredited by members of ILAC, IAAC or EA according to all applicable IEC standards. These reports must be issued no more than 2 years old, considering the date of initial certification process, and must be redone in the renewal
  • Annual factory inspections to maintain certification
  • Initial SAC inspection focusing on whether the Brazilian Representative is in compliance with the requirements of ORD 350 (customer complaints, traceability control of the products bearing the compliance seal, etc.)

Brazil uses international standards to guide their rules, however, these are always adapted to meet local requirements. Transition to the third edition of the IEC 60601-x series of standards, requires extensive commitment from all sectors involved. It was expected that from January 2014 the third edition would be mandatory, but it happened only partially. Currently, Brazilian laboratories hold accreditation to test against some, but not yet all, IEC 60601 third edition standards. Although ANVISA’s Normative Instruction IN 11 includes some deadlines to consider, for example the third edition standards becoming mandatory, test reports according to the standards in the second edition will be accepted until Brazilian laboratories are fully accredited to complete the relevant tests for all standards listed on IN11. It should be remembered that the requirements of ORD 350 are under review. This includes harmonisation with the third edition of the IEC 60601 standards and extensive impacts on documentary analysis and factory inspection.

Import controls

Customs agents check medical devices transported to Brazil against the ANVISA database, to ensure they comply with registration requirements, before they are allowed to enter to the country.

Monitoring certification

Continuity of medical electrical equipment certification, and authorisation for continued use of the certification mark, are based on results of the annual audits of the factory and importer/distributor. Audits are conducted to ensure continued compliance of the product and process, before the certification scheme requirements are established. In addition, during the five years of validity of the certificate, any design changes to a certified product must be reported and approved in advance by the OCP before deployment.

Local representation

To sell your products in Brazil you must not only meet the ANIVSA approval requirements, but also have a representative within the country that can act on your behalf in all product-related matters.

Why choose SGS?

SGS is the world’s leading inspection, verification, testing and certification company. We are recognised as the global benchmark for quality and integrity. With more than 80,000 employees, we operate a network of more than 1,650 offices and laboratories around the world. SGS operates a national and international network of accredited laboratories. Coupled with more than 70 years working in Brazil, our expertise in electrical and electronic products classed as medical devices, makes SGS the partner to trust.

Independent and innovative, our medical devices experts use state-of-the-art facilities and technology to deliver tailor made added value services that help improve your business.
 
We strive to deliver outstanding value at every step in your project by providing:

  • Rapid turnaround
  • Value-based pricing
  • Technical assistance
  • Key account management

Our expertise in compliance management will help you make the right choices for different national markets, while carrying out the necessary testing and certification quickly and professionally.

Contact us

To learn more about SGS’s CGCRE certification services contact your local SGS representative, or contact our global team or visit SGS Medical Devices website.