Regulatory Framework for Importing and Selling Medical Devices, Pharmaceuticals, Supplements and other products in Brazil

Sergio Botinha, attorney-at-law

January, 2016

In order to import and sell most of the medical devices, pharmaceuticals, cosmetics, food, supplements, sanitary and veterinary products in Brazil,  your company may need a number of licenses and registrations at the three-level treasuries (municipal, state and federal) plus a local and a national health surveillance organism in Brazil, among other exigencies, most of all outlined below.

The National Health surveillance agency in Brazil is called ANVISA (“Agência Nacional de Vigilância Sanitária”).  It works very similarly to its counterparts in Europe and in the USA and its licenses are normally not easy to obtain.

There are some standard approaches a foreign company has to take within the intent of gaining access to Brazilian market with the considerable numbers of 200 million citizens, 7^th World economy and a recently empowered middle class. These approaches normally are:

• Establishing its own subsidiary in the country and obtaining all required licenses
• Working with an already established partner company that has some of the required licenses and is able to register the products the foreign company wants to market.

Establishing a subsidiary

If the foreign company decides to establish itself here, the procedure will involve registering its by-laws, using an appropriate location for the foreseen activities (deposit, only administrative, distribution center, etc). The company has to consider municipalities have zoning codes that allow this or that activity per region and that must be carefully observed. Firefighting and Environmental Safety Plans may need to be prepared plus also astate and federal registration obtained.

A Brazilian Resident (a Brazilian national or a Foreigner with a Permanent Visa) will have to act as the company representative. Monthly Accountingwill be needed and an annual localization municipal tax will be paid, besides other pertinent taxation.

If the company plans to import or export products, an importation license must be obtained at the Federal Treasury, called RADAR.

A Company Registration procedure at ANVISA is the next step. At least one medical or special technician (related to the commercialized product) needs to be contracted/hired by the company.

Permanent Visas can be granted for directors and investors, one per each bulk of R$ 150,000 (a hundred and fifty thousand reals) invested. Permanent Visas can be granted for specially skilled workers or technicians.

Using Partners

Because all these steps are time and cost consuming, many endeavors start with a partnership with a company that has all the required licensesand permits, registered with ANVISA and able to register a product for the foreign company.

In this case, the Product Registration will belong to the foreign company, but the registration will be processed through the Brazilian Partner.These partners are normally called “Registration Rental Companies”.

Product Registration

No matter the approach chosen for the company structure, an analysis of the product or line of products has to be performed as to dissecting the regulatory needs for each product being considered for marketing. Products that present medium to higher risks will need to pass through aregistration process at ANVISA and obey labeling guidelines.

Facility Inspection

Depending again on the product risk factor, the production facility will be inspected every two years by ANVISA. ANVISA will also inspect foreign facilities if products are imported and even so if you use partners in Brazil for product registration. A Guide of Good Practices will have to be presented in Portuguese.

Foreign Inspections are nowadays (2015-2016) taking a very long time to be processed. Some companies have been able to obtain judicial orders commanding ANVISA to accept other international certifications as a replacement for the ANVISA inspections. Our offices have successfully obtained these judicial authorizations.

Inmetro Registration

Electronic devices may need one further registration, registration at INMETRO, an agency overseeing electrical products and measuring.

Sales and Distribution

After or meanwhile these establishment and regulatory approaches are taken, the foreign company will normally follow up developing a marketing strategy and distribution channels. The distribution may also occur with the:

• Creating of company’s  own structure of sales representatives
• Partnering with local third parties to sell and distribute

Recently, after an ANVISA authorizing ruling , one strategy has been added – special pharmaceuticals can be distributed through international postal remittance, this being valid for special medicaments plus consumers possessing a prescription.

For any needs on every of the topics above ( PRELIMINARY STUDIES, COMPANY ESTABLISHMENT, LEGAL ASSISTANCE, VISAS, OBTAINING PERMITS AND LICENSES, PRODUCT REGISTRATION , IMPORTATION & TAXATION, FINDING A REGISTRATION RENTAL COMPANY & DISTRIBUTION PARTNERS and MARKET PLANS) BOTINHA & CABRAL has long time expertise and partners to assist you with. Please let us know through the contact form below.