Is your medical device ready for the Brazilian market?

9 April, 2019

If Brazil is your target market for medical devices, be aware of Brazilian particularities

Brazil is the largest healthcare market in Latin America and attracts an increasing number of manufacturers. In order to market medical devices in Brazil you have to get previous approval from the Brazilian Health Regulatory Agency (ANVISA). ANVISA is amongst the world's leading regulatory agencies and has unique and evolving regulations.

Registration process

The registration of health products in Brazil must be carried out by a national company, legally authorized by the local and federal sanitary bodies. Medical devices are classified into four risk classes - I, II, III and IV, which generally correspond to the European I, IIa, IIb and III. The complexity of the ANVISA’s requirements absolutely depends on the product’s risk class. Class I and II devices have a simplified compliance process whilst high risk class products (III and IV) are under a more demanding registration route which also includes a previous Good Manufacturing Practices certification. To date, Cadastro is the registration procedure applicable for class I and II devices. In May 2019, a new and simpler scheme named Notification enters into force for the regularization of class I devices. With this strategy, ANVISA aims to be more focused on the registration of high-risk devices thus making class I product’s registration faster.

Class III and IV devices are under the Registro procedure. Although the technical dossier for ANVISA differs from the European and US technical reports, the previous CE marking or FDA registration will certainly contribute for registration in Brazil. It is important to highlight that for the Registro approval it is mandatory for the manufacturer, both national and international, to be certified according to the Brazilian GMP. This certification is usually obtained through an ANVISA’s on-site audit or, more recently, through the analysis of the MDSAP (Medical Device Single Audit Program) audit report since Brazil is one of the program’s members.

Regulatory agencies

Depending on the product’s features, certifications in other Brazilian Regulatory Agencies may be needed in order to meet the Brazilian regulation and get ANVISA’s approval, e.g. electrical medical devices, hypodermic needles, syringes, gloves, condoms that will require the National Institute of Metrology, Quality and Technology (INMETRO) certification. The National Telecommunication Agency (ANATEL) is another Brazilian authority that deals with safety related to medical devices’ telecommunication and/or accessories that have any wireless communication, e.g. Bluetooth, Wi-Fi.

Even though the Brazilian regulatory system is considered rather complex, our experts will guide you with our comprehensive expertise through the Brazilian regulatory landscape.

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Dr. Albrecht Poth Business Development Medical Devices
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