GENERAL BRAZILIAN RULES FOR MEDICAL DEVICES

According to the Brazilian National Agency of Health Surveillance (ANVISA), a medical device is “a healthcare product, such as equipment, devices, materials, articles, or systems for medical,  odontological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anticonception and that does not use pharmacological, immunological, or metabolic means to fulfill its main function in human beings, but can have its functions assisted by such means”.

Medical devices in Brazil must be registered in ANVISA, in accordance with the Brazilian Resolution RDC. No. 185. Manufacturers or importers of such products must submit to ANVISA all the documents required for the registration as well as for its maintenance, revalidation or cancellation. After evaluating all the documentation, ANVISA publishes its decision on the Brazilian Official Gazette (DOU).

The medical device company must be located in Brazil or it will need a licensed third-party company to be the Brazilian registration holder (BRH), which will hold the registration certificate title. Registration of medical devices is valid for 5 years and after that period it may be successively revalidated for the same period.

According to the risk they represent to consumers, patients, users or third parties involved, medical devices are classified as Class I, II, III or IV. In case of doubts in the classification, ANVISA is the one deciding about the classification. Class II devices have a shorter and simplified registration process (known as ‘Cadastro’), whereas Class III and Class IV need to go through a similar path but a little more complex and with some variants (known as ‘Registro’). Medical devices classified as Class III and IV need to be subjected to Brazilian GMP inspections, which are carried out by ANVISA. As an alternative, manufacturers can partake in the Medical Device Single Audit Program (MDSAP). MDSAP audit reports are accepted as a substitute for routine inspections and may be used for medical device registration in ANVISA.  Since May 2019 (RDC 270/2019), Class I medical devices only need a formal notification to ANVISA and do not need to submit to full ‘Cadastro’ approval (registration is not subject to technical review). This 2019 Resolution main goal was to help ANVISA to focus more on high-risk medical products. On the other hand, companies should make sure they have qualified regulatory team so they can ensure compliance with regulations.

The following medical devices are exempt from registration at ANVISA:

• Medical devices intended for clinical research, when in compliance with legal provisions of the competent health surveillance authority on the performance of this activity, prohibiting such products to be commercialized and used for other purposes.
• New presentations of a medical device set already registered and in intact individual packaging, provided that its label and instructions for use contain the information about the registration of the corresponding medical devices.
• Accessories exclusively manufactured to be part of a medical device with a registration whose technical report has information on such accessories.

INMETRO CERTIFICATION

The National Institute of Metrology, Quality and Technology (INMETRO) is the government body responsible for the implementation of measurement, safety and quality standards for electrical and electronic products. This National Institute is in charge of the notification of proposed technical regulations to the World Trade Organization (WTO) and acts as the national enquiry point under the WTO Agreement on Technical Barriers to Trade (TBT). It guides the activities of accreditation, inspection, testing and certification bodies in Brazil. A broad range of products require INMETRO certification accompanied by inspection, including medical devices (electromedical, regardless of their class).

INMETRO certification (conducted in an INMETRO-certified testing laboratory) must be done prior to ANVISA approval, as it is part of the medical product’s technical documentation required for submission. A product that is certified by an INMETRO-accredited Certification Body ensures that such product is compliant with Brazilian regulations and required safety standards. INMETRO certification is valid for 5 years and may be renewed for additional 5.

Placing and marketing a medical device in Brazil market can be a tough task. With an experienced team located both in the EU and Brazil, Critical Catalyst is available to assist your company in any part of the process, making it easier and assuring compliance with the applicable regulatory requirements.

References:

1. Ministério da Saúde, Agência Nacional de Vigilância Sanitária (ANVISA) – Resolução da Diretoria Colegiada – RDC No. 185, de 22 de Outubro de 2001.
2. Ministério da Saúde, Agência Nacional de Vigilância Sanitária (ANVISA) – Resolução da Diretoria Colegiada – RDC Nº 27, de 21 de Junho de 2011.
3. Ministério da Saúde, Agência Nacional de Vigilância Sanitária (ANVISA) – Resolução da Diretoria Colegiada – RDC Nº 270, de 28 de Fevereiro de 2019.
4. Ministério do Desenvolvimento, Indústria e Comércio Exterior, Instituto Nacional de Metrologia, Normalização e Qualidade Industrial-INMETRO – Portaria nº 350, de 06 de setembro de 2010.