The National Health Surveillance Agency (Anvisa) has recently updated its guidelines on the procedures for classifying borderline products. This revision is part of the 2024-2025 Regulatory Agenda, with the aim of making the process more agile, efficient and predictable, thus facilitating the Brazilian population’s access to new health technologies.
What are borderline products?
These are products which, although they are of interest to health, have specific characteristics (such as composition, mechanism of action or indication for use) which make it difficult to fit them into the traditional categories of products subject to health surveillance, such as medicines, medical devices, food, cosmetics, among others.
This makes the regulatory process more complex and requires careful analysis by Anvisa to define the best regulatory route to follow in order to guarantee their safety and efficacy.
What has changed?
The main change brought about by the updated guidelines refers to the application process and the minimum information required on the Product Classification Form.
Anvisa has clarified in more detail how companies should proceed to apply for their products to be classified, as well as reinforcing the importance of prior consultation with the agency’s service channels. This step helps to ensure that the information and documents submitted comply with the Agency’s requirements.
In addition, the revision has been incorporated into the Regulatory Agenda 2024-2025, which aims to revise regulatory procedures in order to make them more efficient and predictable, promoting innovation in the country.
This change is in line with Anvisa’s strategic objectives of supporting the development of new technologies in Brazil, especially those with the potential to transform healthcare.
How does the classification of border products work?
Currently, the classification of border products is carried out by the Comitê de Enquadramento de Produtos sujeitos à Vigilância Sanitária (Comep), an advisory body to Anvisa. This committee helps define the regulatory framework for products that do not easily fit into the traditional health surveillance categories.
Comep is made up of representatives from various technical areas of Anvisa, such as registration, inspection, regulatory quality and product monitoring, and its decisions serve as input for Anvisa’s Collegiate Board (Dicol).
The committee was established by Anvisa Ordinance 1,354 of 2016 and its workflow is regulated by Anvisa Ordinance 1,744 of the same year.
Benefits of the Update
The revision of the guidelines for the classification of frontier products brings significant benefits for companies and society, including:
- Agility and Clarity: The new format of the application process brings greater transparency and predictability for companies, reducing bureaucracy and increasing efficiency in the regularization process.
- Easier Access to Innovations: With faster and clearer procedures, it is possible to promote faster access to new innovative products in Brazil, contributing to the advancement of the health sector.
- Support for National Innovation: The change reflects Anvisa’s commitment to boosting the development of promising technologies in Brazil, especially those with the potential to bring significant benefits to public health.
Updating the guidelines for the classification of frontier products is an important step towards improving Anvisa’s regulatory processes and stimulating innovation in the health sector. This changes bring greater clarity, efficiency and predictability, benefiting both companies and society by facilitating access to new products and technologies.
If you are involved in the development or marketing of innovative health products, it is essential to be aware of the new guidelines and seek the appropriate advice to ensure that your product is correctly framed and regularized before Anvisa.
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