Medicines, medical devices and other health products are among the most regulated activities in Brazil. Market entry depends on the corporate structure chosen to hold authorisations and registrations with ANVISA, and on the rules governing prices, promotion and distribution.
Legal questions we address
- Company operating authorisation (AFE) and product registrations with ANVISA, and the choice of the Brazilian entity that holds them.
- Price regulation of medicines by CMED.
- Distribution, licensing and manufacturing agreements, including contract manufacturing.
- Clinical research agreements and the related regulatory requirements.
- Intellectual property and regulatory data in product launches.
- Acquisitions of companies and product portfolios, with regulatory due diligence.
Key considerations
ANVISA registrations are held by a company established in Brazil with an operating authorisation. When a local partner is the holder, a later change of partner requires the registrations to be transferred, which takes time and depends on the partner’s cooperation. It is advisable to decide at the outset which company will hold them.
Law 14,874/2024 sets the rules for research involving human beings and gives ANVISA 90 business days to analyse initial clinical trial applications. Several provisions still await regulation, which makes the agreements between sponsors, research centres and investigators particularly important.
CMED sets maximum prices for medicines, using criteria that include prices in reference countries. The authorised price affects the commercial plan and, in acquisitions, the valuation of product portfolios.
How the work is organised
In life sciences, the corporate and contractual structure must follow the regulatory route. The mapping stage aligns the corporate decision with registration timelines and with the regulatory consultants involved in the project.
Main legal framework
Law 6,360/1976 (health surveillance) · Law 9,782/1999 (ANVISA) · Law 10,742/2003 (CMED) · Law 14,874/2024 (research involving human beings)
Information updated in November 2026. General information; it does not constitute legal advice.