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New Anvisa Technical Standards: Ensuring the Quality and Safety of Medical Devices

On March 8, the National Health Surveillance Agency (Anvisa) announced the publication of the updated list of Technical Standards applicable to the certification of conformity of equipment subject to the Health Surveillance regime. These technical standards represent the essential criteria to ensure that equipment complies with the regulations established by health authorities, thus guaranteeing the safety and quality of products on the market.

In the context of the Brazilian Conformity Assessment System (SBAC), these standards play a fundamental role in evaluating the conformity of equipment, establishing clear guidelines for manufacturers and regulators to follow. By adhering to specific technical standards outlined by Anvisa, manufacturers of healthcare equipment and related products can demonstrate that their products meet the highest safety and quality standards required by the country’s health authorities.

Periodically updating this list of technical standards is crucial to keep up with technological advances and regulatory changes, ensuring that equipment sold in the Brazilian market complies with the latest safety and quality standards.

The release of this updated list represents a significant milestone for the health equipment industry and for professionals involved in the regulation and inspection of Health Surveillance, reaffirming Anvisa’s commitment to promoting the safety and effectiveness of products available to Brazilian consumers.

Access the full normative instruction by clicking the button below:


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