SGS Helps Optimize Market Access in Brazil in Accordance with INMETRO and ANVISA Regulations

Aug. 19, 2015 - PRLog -- 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 - Accredited Certifier in Brazil

SGS gives organizations the ability to achieve these twin goals of optimization 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 global expertise, the company also works 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 commercialization 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 requirement. Globally, certification provides adequate controls with regard to international trade, while at the same time strengthening Brazil’s internal market.

Definition of Medical Devices According to ANVISA

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 Organization of Certification of Product (OCP). SGS is accredited as an OCP by CGCRE (the Brazilian Authority for accreditation of product certification bodies) to issue certificates. The company 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
- Motorized wheelchairs

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

From CGCRE Certification to INMETRO Mark

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 Ordinance 350, issued by INMETRO on 6 September 2010. The current evaluation mechanism used by OCPs to issue the compliance certificate can be summarized in the following steps:

Monitoring Certification

Continuity of medical electrical equipment certification, and authorization 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.

About SGS Services for Consumer Medical Devices

SGS is the world’s leading inspection, verification, testing and certification company. The company is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 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, the company’s expertise in electrical and electronic products classed as medical devices, makes SGS the partner to trust.

To learn more about SGS’s CGCRE certification services contact a local SGS representative.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.