The National Health Surveillance Agency (ANVISA) has recently updated its guidelines regarding the importation of medical device components, in response to the new Resolutions of Collegiate Councils (RDC) 860/2024 and 939/2024. These updates specifically impact finished medical products that require regularization with the Agency.

Key clarifications include:

1. Exemption from Operating Authorization:

• Medical Device Components: Importers of medical device parts are no longer required to obtain an Operating Authorization for imports, regardless of whether the component is used to manufacture a domestic medical device or for the repair and replacement of medical equipment in use. This exemption is based on Article 3 of RDC 16/2014.

• Medical Device Accessories: Importers of accessories, where the accessory is part of the regularization process for a finished medical device or in vitro diagnostic (IVD), are also exempt from the Operating Authorization requirement.

2. Operating Authorization Requirement:

• Regulated Accessories: Importers of medical device accessories that are subject to their own specific regulations (under RDC 751/2022 or RDC 830/2023) are still required to obtain an Operating Authorization. These components are considered finished medical devices and are subject to the standard importation procedures.

These updates are designed to streamline the import process for medical device components and clarify the regulatory obligations of importers, ensuring compliance with ANVISA’s evolving standards.

ANVISA's recent clarifications regarding the import of medical device components bring a medium to high impact on the industry, offering a balance of regulatory clarity, operational efficiency, and enhanced safety standards.

• Streamlined Import Process: The updated guidelines simplify importation procedures, making it easier for companies to comply with regulations. This can lead to faster processing times, accelerating the entry of critical medical components into the market.

• Cost Savings & Reduced Bureaucracy: The exemption from Operating Authorization for certain importers—particularly for parts and accessories—will help reduce operational costs and minimize bureaucratic hurdles, enabling companies to focus resources on core business functions like innovation and product development.

• Maintaining High Standards: For those components still subject to Operating Authorization, the requirement ensures that only high-quality, safe medical devices and accessories enter the market. This plays a critical role in protecting public health and ensuring patient safety.

• Market Flexibility: By easing restrictions for specific categories, ANVISA provides importers with greater flexibility, allowing essential components to be brought to market more quickly and efficiently.

In essence, these updates strike a balance between operational efficiency and robust regulatory oversight, benefiting the medical device industry while safeguarding public health.

• Medical Device Importers: Importers will benefit from reduced administrative burden and clearer guidelines.
• National Manufacturers: With quicker access to components, manufacturers can improve production timelines and product availability.
• Health Sector: Hospitals, clinics, and healthcare providers will benefit from more timely access to high-quality, regulated products.

ANVISA's clarifications offer a medium impact that enhances trade efficiency, reduces bureaucracy, and ensures continued adherence to quality and safety standards. This approach will ultimately benefit the entire healthcare ecosystem by ensuring faster access to critical medical products, while maintaining rigorous safety standards.

Regulatory Impact: 

• Top Priority: Yes
• Type of Certificate: Yes
• Spectrum Bands: No
• Import Changes HS Codes: No
• Standard Changes: No
• Product Changes: Yes
• Label Changes: No