12/03/2019

How to register surgical instruments in Brazil

How to register surgical instruments in Brazil

Surgical instruments are items that are part of the routine of thousands of health professionals. Therefore, companies arround the world are betting on this sector that presents a considerable growth.

Attention! Before selling these products in Brazil, surgical instruments must be registered with the National Agency of Sanitary Surveillance (ANVISA).

Because they are directly linked to health, there are many specifications and requirements of ANVISA that may hinder the registration process for people who are not accustomed to the regulatory language.

That's why Stotone Okamont produced a complete material on how to register surgical instruments in Brazil. With more than 30 years of expertise, Stone guarantees excellent results, fast and low costs when registering your product with ANVISA. Check out our story and learn how to do this process.

What are surgical instruments?

Tools for surgical use for cutting, drilling, sawing, reworking, scraping, stapling, pulling, clamping or otherwise, without connection to any active medical device.

Operating License to register surgical instrument in Brazil

To register surgical instruments in Brazil, the first step is to obtain the Operating License for your establishment. It is acquired through an inspection performed by VISA, that means, the Local Sanitary Surveillance, which evaluates the company's technical, administrative and operational conditions. The documents of the company, including the municipal licenses and authorizations, are objects of this inspection.

See what documents your business needs.

Is business authorization necessary?

The AFE, Business Operation Authorization, is mandatory to register a surgical instrument in Brazil. It is granted by the National Health Surveillance Agency, through publication in the Official Gazette of the Union, after analysis and approval of the agency to the request. The acquisition of the AFE means that the company acts in accordance with Brazilian legislation and is able to operate throughout the national territory.

This certificate is reserved for legal companies incorporated in Brazil. In this way, a foreign company that has an interest in marketing its products in the Brazilian market, it must have a commercial agreement with a company in Brazil. Not necessarily this company must be a subsidiary of the foreign company, being possible that the Brazilian company is only an importer, which will assume the technical and legal responsibility of the foreign company in Brazilian territory.

Risk class in the registry of surgical instruments in ANVISA

The beginning of the registration process for surgical instruments at ANVISA is to frame your product in some Risk Class. The Risk Class takes into account the characteristics and complexity of the product, with I being the lowest and IV being the highest.
Because these materials can address several stages and types of surgical interventions, it is necessary to categorize the product with the rules established by the legislation. Below, check out some of the types and classes for registering surgical instruments at ANVISA.
• Reusable surgical instruments fall into class I
• Single use surgical instruments fall into Class II

I want to consult the Class of my product.

Do I need the Certificate of Good Manufacturing Practices for surgical instruments at ANVISA?

After classification of the product, if it has been classified in Risk Class III or IV, the company must obtain a Certificate of Good Manufacturing Practices to register surgical instruments in ANVISA.
The certification comes from an analysis of the Quality System implemented in the company. This system consists of manuals, procedures and records that optimize the operation and guarantee the quality in the production of surgical instruments.

How to start the registration of surgical instruments in ANVISA?

The registry of surgical instruments in ANVISA follows many types of classifications that may disrupt those who are not accustomed to the regulatory language.

Stone Okamont has the best service and offers its customers intelligent solutions that will help in the time and cost of the process.

 Contact us and find out how Stone Okamont can help your company achieve success! Click here!

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