DRW Monthly
March 2008
Issue No. 16

Brazilian Medical Device Import Regulations

The registration and approval of medical devices in Brazil is handled by ANVISA, the National Health Surveillance Agency. ANVISA, which was established by Law 9.782, of January 26, 1999, is an independently administered, financially-autonomous regulatory agency that is managed by a Ministry of Health appointed board of directors. Among the agency's assigned programs is the control of the national sanitary surveillance system for foods, medicine, medical devices and cosmetics; oversight of the country's blood products; administration of the national program for prevention and control of hospital infections; monitoring of medical product prices; regulation and control of tobacco products; and technical patent support services. The Office of Medical Device Technology which operates within ANVISA is directly responsible for medical device product registration.

A company seeking to market its medical devices in Brazil must first obtain a local representative. The representative can be an in-country agent or a local subsidiary office or manufacturing unit established by the company. Prior to registering any medical device products, the local office or agent must receive authorization from ANVISA to import the devices by filing a request to operate with a local Health Surveillance Secretariat within the agency. The local Secretariat will then visit the company's operations before granting authorization which can take from 3 to 12 months depending on the company's location.(1)

Once authorization is obtained, the local representative may register a medical device with ANVISA. This representative will then become the only company authorized to sell or distribute this product in Brazil. The registration process must be completed 90 days after the registration is requested and the registration typically lasts for five years.(2) The product must be renewed either by the same representative or by re-registering the product with a new representative who would be required to repeat the entire registration process. The revalidation process must be completed at least six months prior to the expiration of the existing registration.

In addition to ANVISA's registration requirements, medical device companies must also comply with the Code of Consumer Protection and Defense, approved on September 11, 1990. The Code ensures consumers that equipment is safe and will be used correctly by requiring companies to provide sufficient documentation to demonstrate the safety of their products and include instructions in Portuguese on the proper use of the equipment.(3) Medical device products covered by this Code are classified according to one of four perceived levels of risk:

Medical device companies in India have voiced concerns that the overlap between the provisions of these two bills could result in a period of extreme confusion for the industry once the legislation is passed. At this point, the industry is waiting to see which ministry will be taking the lead on implementing the key provisions of each of bill. Concerns have also been raised about amending the Drugs and Cosmetics Act, 1940 to include medical devices when the Act is primarily designed to regulate drugs and cosmetics. It is clear that many issues will need to be hashed out by all the stakeholders if a new regulatory system for medical devices is to be successfully implemented.

• Level I - product with little health risk, but needs registration;
• Level II - product with low health risk;
• Level III - product with medium health risk;
• Level IV - product with high health risk.(4)

ANVISA has further added to an importing company's documentation requirements with two Resolutions (185 and 3.385) issued in 2006. These Resolutions require medical and in vitro diagnostic medical device companies to submit detailed, foreign economic and market pricing data from up to ten countries in order to register their products in Brazil.(5) This requirement has been explained by ANVISA as being necessary to establish an economic database, which would include product-specific prices in other countries as well as Brazilian product price, consumer and tax data.

It is clear that medical device companies endeavoring to export their products to Brazil face a labor-intensive registration and approval process. In addition to the rigorous registration requirements imposed by ANVISA, companies must also factor in Brazil's cascading tax regime which essentially results in taxes being calculated on top of other taxes. The four main taxes usually paid during the customs clearance process include the import duty, the industrial products tax, the merchandise circulation tax and the PIS/Pasep and COFINS import taxes.(6) To promote the greatest chance of success, a company's export strategy should include selecting local representatives or distributors with expertise in import legislation and market trends as well law firms that are familiar with Brazilian regulations.

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