ANVISA recently published clarifications on the rules governing the import of medical device components into Brazil. This update aims to reinforce the safety and compliance of healthcare products, ensuring that all imported items meet regulatory requirements and comply with established quality standards.
According to ANVISA's guidelines, medical device components must be linked to products that are duly regulated in Brazil. This measure is essential to ensure that imported parts are aligned with the specifications of the final devices, avoiding risks to patients' health and the operation of the equipment. This regulation reinforces transparency and facilitates market control, providing greater security for manufacturers, distributors and users.
For companies and importers, it is essential to follow these guidelines, ensuring that all processes comply with regulatory requirements, avoiding supply interruptions or compliance issues.
For more information on the rules and procedures, access the official Anvisa statement: https://lnkd.in/dSBsMypm
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