The sanitary registration of a health product is the authorization issued by ANVISA (National Health Surveillance Agency) that allows the manufacture, import, marketing and use of products intended for the health area in Brazil. The registration certifies that the product has been analyzed and meets the quality, safety and efficacy criteria required by health legislation.
This process is essential to ensure that the product is fit for use, respecting all the safety standards imposed by regulatory bodies.
What is Considered a Health Product?
Healthcare products are medical devices used in the prevention, diagnosis, treatment or rehabilitation of diseases. These may be used in medical, dental, laboratory or home environments, and must meet the regulatory requirements of ANVISA in order to be legally marketed in Brazil.
Examples of Products that Require Health Registration
Below, we list some of the products that require health product registration:
- Medical equipment: heart monitors, electric scalpels, respirators
- In vitro diagnostic products: rapid tests, reagents, analysis kits
- Hospital materials: catheters, syringes, needles, surgical gloves
- Prostheses and implants: orthopaedic, dental, cardiovascular
- Dental devices: drills, resins, braces
For more information, you may consult the ANVISA portal directly.
What are the objectives of the Health Registry?
The main purposes of the ANVISA health registration are:
- Protect public health by preventing the use of unsafe or ineffective products;
- – Ensure the quality, efficacy and safety of health products;
- Regularize the operations of companies in the health sector;
- Allow traceability and sanitary control of marketed products.
Stages of the Health Registration Process
The registration process varies according to the risk class of the product:
- Class I – Low risk
- Class II – Moderate risk
- Class III – High risk
- Class IV – Maximum risk
The greater the risk, the stricter the requirements. The process can include:
- Delivery of complete technical and legal documentation;
- Clinical and laboratory test reports (where applicable);
- Certification of good manufacturing practices and ISO 13485;
- Information on labeling, instructions for use, packaging and manufacturing.
Useful links:
- Learn more about obtaining the Company’s Authorization to Operate (AFE);
- See also: Product hosting and legal representation in Brazil
The health registration of health products is essential for companies that work in the health sector and wish to market their products in Brazil. This process ensures that products meet the legal and technical requirements of ANVISA, promoting greater safety for professionals and patients.