The Health Products area encompasses a broad and diverse universe of regulated items at different levels of complexity. From a simple gauze compress or infrared lamp to resonance equipment. In this blog, we will delve into this subject in greater detail and explain how to obtain regulatory approval from ANVISA.
What you'll find in this Blog:
In Brazil, several health products need to be regulated by the National Health Surveillance Agency (ANVISA) before they can be marketed or used. Some examples of products that require regulation by ANVISA include:
Including human, veterinary, and herbal medications.
Such as diagnostic equipment (e.g., magnetic resonance imaging, CT scanners), surgical equipment (e.g., electric scalpels), dental equipment, among others.
Such as gauze, dressings, syringes, needles, surgical gloves, catheters, implants, prosthetics, among others.
In-vitro diagnostic products:
Reagent kits and equipment used in laboratories for disease or infectious agent detection.
Personal hygiene products, perfumes, cosmetics, and more.
Soaps, disinfectants, wet wipes, and more.
Products used for cleaning and disinfecting environments, such as detergents, disinfectants, insecticides, etc.
Dental materials such as cements, resins, and others.
Equipment and products used in aesthetic treatments.
This list is not exhaustive, and the regulation of products by ANVISA may change over time. It is important for companies or professionals in the healthcare field to check which products require registration or notification before marketing or use in the country. Regulatory compliance with ANVISA is essential to ensure the safety and efficacy of products and to comply with current health legislation.
This diversity of products reflects the importance of the Health Products field, as it plays a crucial role in providing resources and tools for healthcare professionals to perform precise diagnoses, effective treatments, and quality care. From simple daily-use products to high-tech equipment, all play a vital role in supporting public and private healthcare.
However, this variety also requires rigorous regulation to ensure the safety, efficacy, and quality of products offered in the market. Government regulatory agencies work together with industry companies to establish standards, regulations, and guidelines that ensure product compliance with legal and sanitary requirements.
Regulating health products is a process that involves registration, enrollment, or notification with the National Health Surveillance Agency (ANVISA) in Brazil. The type of regulation required depends on the risk and classification of the product. Here are the main steps to regulate health products with ANVISA:
Product classification: The first step is to classify the product according to ANVISA regulations. Products are divided into risk classes (I, II, III, and IV), and each class has specific procedures for regulation.
Class I: Low risk;
Class II: Moderate risk;
Class III: High risk;
Class IV: Maximum risk.
Preliminary research: Before starting the regulation process, it is essential to conduct detailed research to understand the specific requirements for the product in question. Visit the ANVISA website for up-to-date information on your product's regulation.
Process preparation: Prepare all the necessary documentation for product regulation. This includes technical information, clinical trials (if applicable), manufacturing data, quality verification, labeling, and usage instructions, among others.
Registration, enrollment, or notification request: Submit the complete regulation process to ANVISA through the electronic system provided by the agency. The process will be assessed by ANVISA technicians to verify product compliance with established requirements.
Facing difficulties in regulating health products? Don't worry! Stone Okamont has the ideal solution for you. We have a team specialized in regulatory affairs, ready to provide all the necessary support. Contact us now and let us help make the process easier and more efficient for you.
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