New Regulation Implementation
The Brazilian Agency for Sanitary Surveillance (ANVISA) issued Normative Instruction No. 290/2024 on April 8th, 2024. This new regulation aims to streamline the evaluation process for medical devices and in vitro diagnostic devices (IVDs) that have received approval from certain foreign regulatory authorities. The instruction is designed to expedite the market entry of these medical devices and IVDs in Brazil by leveraging existing approvals from recognized international bodies, thus reducing redundancy and accelerating access to advanced healthcare technologies in the country.
Key Aspects of the Instruction
Key aspects of Normative Instruction No. 290/2024 include the recognition of foreign approvals, allowing for the acceptance of evaluations and approvals from specific foreign regulatory agencies, such as the FDA (United States), EMA (European Union), PMDA (Japan), and TGA (Australia). This means that devices and diagnostics already approved by these agencies may undergo a simplified review process by ANVISA. Additionally, the regulation streamlines documentation requirements, enabling manufacturers to submit documentation used for approval by the recognized foreign authorities, potentially reducing the volume and complexity of paperwork required by ANVISA.
Expedited Review Process
The use of pre-existing approvals can lead to an expedited review process, allowing for quicker market access in Brazil. This is particularly beneficial for innovative or critical medical devices and diagnostics that can improve patient care. However, not all foreign-approved devices and diagnostics will automatically qualify for streamlined evaluation. They must meet specific criteria set by ANVISA, ensuring that only those devices that align with Brazilian regulatory standards are considered for the expedited process.
Procedural Steps for Manufacturers
The instruction outlines the procedural steps for manufacturers to follow, including application submission, required documentation, and timelines. Compliance with ANVISA's post-market surveillance and reporting requirements remains mandatory. This normative instruction reflects ANVISA's commitment to improving regulatory efficiency and facilitating access to high-quality medical technologies while ensuring safety and efficacy for Brazilian patients.
Regulatory Impact
- Top Priority: Yes
- Type of Certificate: No
- Spectrum Bands: No
- Import Changes HS Codes: No
- Standard Changes: Yes
- Product Changes: No
- Label Changes: No
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |