🤝🔬 The collaboration between Anvisa (National Health Surveillance Agency) and ANMAT (National Administration of Drugs, Foods, and Medical Technology) is streamlining access to medical devices between Brazil and Argentina! 🌎✨
Recently, the regulatory agencies signed an agreement to facilitate the approval and trade of low-risk medical devices. This agreement allows for the mutual recognition of certificates of free sale and certificates for foreign countries for medical devices classified as Classes I and II, as well as In Vitro Diagnostic medical devices A and B, between Anvisa and ANMAT, based on Law No. 9782/1999. Medical devices that will benefit from this bilateral agreement must meet the following regulatory requirements:
• Low-risk medical devices that do not pose significant health or life risks to individuals.
• Medical devices classified according to the classification rules established by Anvisa and ANMAT.
• Medical devices must be regulated with Anvisa or ANMAT, as appropriate, through notification or registration procedures, depending on the risk class.
•Medical devices must comply with labeling and instructions for use defined by Anvisa and ANMAT, following international standards.
•Medical devices must have a certificate of free sale and a certificate for a foreign country issued by the health authority of the country of origin, which will be mutually recognized by Anvisa and ANMAT, without the need for apostille and translation into Spanish, reducing time and cost.
•Medical devices must comply with good manufacturing practices, control and distribution standards, as well as post-market surveillance standards, as per the legislation of each country.
This partnership aims to optimize resources, processes, and regulatory outcomes, avoiding rework and fostering mutual trust. The mutual recognition of decisions and documents issued by national authorities seeks to simplify bilateral trade and regulatory cooperation. Together, we are building a more agile and efficient path for the regulation of medical devices, benefiting the health and well-being of our communities.
If you have any questions, please share them in the comments below; our team is available to assist! To access the official announcement, click here.
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