Classification of Medical Health Products at Anvisa

When dealing with the import of products regulated by ANVISA, it is vital to understand the different classes assigned to these products, which range from class 1 to class 4. Each class indicates the level of health risk and imposes different regulations and requirements for import and marketing. This classification is determined on the basis of 18 rules that cover the majority of healthcare products. Anvisa considers various factors when drawing up these rules, such as the duration of contact, invasiveness, route of administration, purpose, consequences of failures and associated technologies. Let’s explore these classes in detail:

Class 1: Low Risk

Class 1 products are considered to be of low risk to public health. This includes items such as certain cosmetics, personal care products and simple medical devices, which have a proven track record of being safe to use, with no chance of complications. For example, moisturizing creams, soaps, simple dressings, surgical drapes and digital thermometers are typically classified as Class 1 by ANVISA.

Class 2: Moderate Risk

Class 2 products present a moderate risk to public health and are subject to stricter regulations than Class 1 products. This includes more complex medical devices that actively administer drugs, products that come into direct contact with orifices or internal body layers and will have a low contact time.

Class 3: High Risk

Class 3 products pose a high risk to public health and are subject to even stricter regulations. This includes prescription drugs, invasive medical devices, devices that emit ionizing radiation, devices in body orifices that will remain for long periods, complex dressings, devices that monitor vital functions, control these functions and administer highly dangerous fluids and drugs, as well as highly regulated chemicals.

Class 4: Maximum Risk

Finally, Class 4 products represent the highest risk to public health and are subject to intensive control by ANVISA. This includes substances and devices with biological products, invasive monitoring systems, equipment that maintains direct contact with the Central Nervous System and Cardiovascular System, as well as some controlled drugs.

Given this regulatory complexity, it is essential to rely on reliable partners to help obtain product registration with ANVISA. Humana Importadora offers a full range of services to help companies and entrepreneurs at every stage of the import process, from initial consultancy to product distribution. Count on us to ensure that your products meet all ANVISA regulations and requirements, providing a smooth and successful import.