The Future of Importation: The Impact of ANVISA’s New Resolution on the Medical Devices Sector.
ANVISA has recently published a new resolution that alters the rules for importing medical devices, including their accessories, into Brazil. This resolution, RDC No. 810/2023, aims to facilitate access for healthcare professionals and patients to the products they need, without compromising their safety and quality.
The resolution allows medical devices manufactured before the dates of ANVISA notification or registration to be imported, as long as the time gap is within 5 years and the products are the same as those approved by the agency. This is to prevent waste of products still usable but restricted due to manufacturing dates.
Furthermore, the resolution sets out requirements for additional documentation in the importation processes, such as the manufacturer’s declaration regarding the manufacturing date and product validity, the conformity certificate issued by an entity accredited by Inmetro, and proof of payment of the sanitary surveillance inspection fee¹. These documents must be presented within a maximum of 30 days after the product arrives in the country.
The resolution came into effect on its publication date, which was August 18, 2023, and it amends the Collegiate Board Resolution – RDC No. 751, of September 15, 2022, which deals with risk classification, notification and registration procedures, as well as labeling requirements and instructions for using medical devices.
This resolution brings positive prospects for companies operating in the medical devices sector, as it simplifies the process of importing products previously approved by ANVISA. However, it is important to emphasize that imported medical devices must meet the same quality and safety standards as domestic products, and ANVISA has the authority to inspect and monitor the products at any time.
At Passarini Group, we are regulatory consulting experts in healthcare products. We can assist you in getting your products compliant with ANVISA, Inmetro, Anatel, and international authorities. Our qualified and experienced team stays updated with changes in sanitary legislation, offering personalized solutions for your needs. Contact us to learn more about our services.
For further clarification, please contact Passarini Group! We would be delighted to assist you through email: contato@passarini.com.br.
Passarini Group
Published: 08/21/2023 – Source: ANVISA
