Brazil
Brazil is the largest medical device market in Latin America, with an estimated value of over $10 billion and an annual growth rate of 6%. The sector is characterized by strong demand for imported products and a strict regulatory system supervised by ANVISA, which ensures device compliance and safety.
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Regulatory Framework
The competent authority is the Agência Nacional de Vigilância Sanitária (ANVISA).
Device Classification:
- Class I: Low risk
- Class II: Moderate risk
- Class III: High risk
- Class IV: Very high risk
Specific Local Requirements
| Language | Documentation in Portuguese. |
| Local Representative (BRH) | Mandatory for foreign manufacturers. |
| Certifications | ISO 13485, CE, FDA, and Certificate of Free Sale facilitate the process; MDSAP certifications are automatically recognized. |
| Clinical Trial Registry | Public for all devices using data from Brazilian studies. The obligation applies to Class III and IV devices, while for Class I and II it may be required based on ANVISA's indications. |
Challenges and Operational Advice
- Complex regulations: The process is detailed and requires experience.
- Variable evaluation times: Class III and IV devices may face delays due to additional checks or documentation requests.
- MDSAP compliance: MDSAP certification is strongly recommended to streamline the approval process and facilitate market access.
Why Choose ISEMED
- Latin America Expertise
In-depth knowledge of ANVISA regulations and local support. - MDSAP Assistance
Support with Brazilian MDSAP certification, including preparatory audits, specific consulting on ANVISA compliance, and assistance in managing the required documentation for approval. - Approval time optimization
Targeted strategies to reduce approval timelines and ensure effective registration.
FAQ
- Is a local representative required? Yes, BRH.
- Documentation language? Portuguese.
- License duration? 5 years.