Brazil

Country Information:

Brazil is the largest country in South America, with a population of approximately 213 million people. The capital is Brasília, and Portuguese is the official language. Brazil’s healthcare system is a mix of public and private providers, with significant growth in private healthcare as demand increases for quality services. Major cities like São Paulo and Rio de Janeiro have highly developed healthcare infrastructure, while rural areas are underserved.

Medical Devices Market Size:

Brazil is the largest medical device market in Latin America, valued at over USD 10 billion in 2023. The market is driven by the country’s large and diverse population, the expansion of private healthcare facilities, and growing demand for advanced medical technologies. Medical device imports represent a large portion of the market, with an increasing trend towards local manufacturing and regulatory reforms.

Future Growth Potential:

The Brazilian medical device market is projected to grow at a compound annual growth rate (CAGR) of 8% from 2023 to 2028. Growth drivers include:

• A growing aging population.

• Expanded access to healthcare in remote regions.

• Increased private healthcare investments.

• Upcoming regulatory changes that simplify the market entry process for foreign companies.

Registration Process:

To market a medical device in Brazil, you must register with ANVISA (Agência Nacional de Vigilância Sanitária), the country’s regulatory authority. The registration process includes:

• Classification: Devices are classified into four categories (Class I to IV), with more stringent requirements for higher-risk devices.

• Local Authorized Representative (LAR): Foreign manufacturers must appoint a LAR in Brazil who will manage the registration process.

• Required Documentation: Technical file, clinical data, evidence of conformity to Brazilian Good Manufacturing Practices (B-GMP), risk management documents, and product labeling in Portuguese.

• Approval Timeline: The registration process can take 8 to 12 months, depending on the device class and complexity.

Other Information:

• Brazil is an attractive market but presents challenges such as high import taxes, complex regulatory requirements, and local competition.

• A recent move towards regulatory alignment with international standards, including the Medical Device Single Audit Program (MDSAP), helps streamline the approval process.

Brazil (ANVISA Registration Process) Flowchart:

1. Classify Device
   → Class I, II, III, IV

2. Appoint Local Authorized Representative (LAR)
   → Required for foreign manufacturers

3. Prepare Documentation
   → Technical file, clinical data, B-GMP compliance, labeling in Portuguese

4. Submit Registration Application to ANVISA
   → Via online submission or through LAR

5. Testing (if applicable)
   → Toxicology, clinical trials, etc.

6. Approval by ANVISA
   → Issuance of Registration Certificate