New Regulation on Authorization to Operate for Imports

The Brazilian Health Regulatory Agency (ANVISA) has recently announced the publication of Resolution of the Collegiate Board (RDC) 860/2024. This new regulation updates RDC 16/2014, which outlines the criteria for obtaining Authorization to Operate (ATO) and Special Authorization for companies. The changes aim to clarify the process for importers of goods and products subject to health surveillance.

Key Changes Introduced by RDC 860/2024

The new resolution introduces significant changes to RDC 16/2014, particularly concerning exemptions from ATO requirements for specific types of businesses. The following categories of companies are exempt from needing an ATO, with important notes on when an Authorization to Operate is still required:

1. Retail Companies Selling Health Products for Lay Use

Retail businesses that sell health products directly to consumers do not need an ATO. However, if these companies engage in importation activities, they must obtain an ATO as per Article 3 of RDC 16/2014.

2. Branches or Subsidiaries Not Handling Health Products Requiring ATO

Companies that do not handle health products subject to ATO requirements are exempt. If they begin importation activities, they must obtain an ATO in accordance with Article 3 of RDC 16/2014.

3. Companies Handling Non-Special Control Raw Materials and Components

Businesses involved solely in the manufacturing, distribution, storage, packaging, export, fractioning, transport, or importation of raw materials, components, and inputs not subject to special control are exempt. These materials must be intended for the production of health products, cosmetics, personal hygiene products, perfumes, and sanitizers. If these companies import materials, they need an Authorization to Operate (ATO) as stated in Article 3 of RDC 16/2014.

4. Companies Providing Installation, Maintenance, and Technical Assistance for Health Equipment

Companies that exclusively install, maintain, and provide technical assistance for health equipment are exempt. However, if they import spare parts or accessories for medical or diagnostic equipment, they need an ATO to import these medical devices.

5. Companies Importing Products for Clinical Trials and Related Programs

Businesses importing products exclusively for clinical trials, expanded access programs, compassionate use programs, and post-study medication supply programs are generally exempt if they hold the necessary authorization documents from ANVISA. Companies holding a Special Communication (CE), Specific Special Communication (CEE), or Importation Document for Investigational Products are exempt. If imports are conducted by entities other than the holders of specific clinical dossiers (DDCM, DICD, DDCTA/DSCTA), they are not exempt from ATO.

6. Companies Importing Products for Quality Control or New Product Development

Companies that import goods exclusively for quality control laboratory analysis or the development of new products, and those covered under Chapter XXI of RDC 81/2008, are exempt from needing an ATO for importation.

7. Scientific, Technological, and Experimental Development Institutions

Institutions focused solely on basic or applied scientific research, technological development, or new product/service/process development are exempt from ATO requirements for their importation activities.

8. Companies with special authorization for Laboratory or Research Institution Importing for Own Use

Companies with special authorization for laboratories or research institutions importing products for their research activities do not need to include importation in their special authorization activities. This exemption also applies to imports for the development of new products.

Implications for Businesses

The updated regulation by ANVISA aims to simplify and clarify the requirements for companies engaged in importing health-related products. Businesses should review these changes carefully to understand their obligations and ensure compliance. Here are some steps companies can take to adapt to the new regulation:

  1. Review the Updated Regulation: Understand the specific exemptions and requirements applicable to your business activities.
  2. Ensure Proper Documentation: Maintain accurate and detailed documentation to comply with ANVISA’s standards.
  3. Seek Regulatory Guidance: Consult with regulatory experts to navigate the new requirements effectively.
  4. Train Staff: Ensure your team is well-informed about the updated regulations and compliance procedures.

For more detailed information, visit ANVISA’s page here.