ANVISA promotes changes in the Regulatory Framework for medical devices that aim to bring legal certainty to importers
The advent of RDC 751/2022 was important for the medical devices sector, as it updated Brazil’s regulatory framework after 2 (two) decades of validity. However, despite all the discussion that headed its publication, the Brazilian Health Regulatory Agency (Anvisa) needed to update it quickly to bring more legal certainty to the regulated sector, as well as to equate points observed from the beginning of its validity, in March of this year.
Some importers of medical devices would be hampered by the lack of normative rules concerning the possibility of importing products that were manufactured prior to the effectiveness of RDC 751/2022, but needed adaptation to the new framework, for example, class adjustment of risk.
The quick update of the regulation seeks to bring legal certainty to the sector, given the vast majority of international manufacturers do not manufacture exclusively in Brazil, and may have a considerable stock of products to be shipped to the country. Reporting Director Alex Machado Campos highlighted the risk of market shortages if the changes were not proposed:
- “The technical area warns that all production of medical devices is not focused exclusively on the Brazilian market, therefore, it is understood that the new measure adopted could lead to a shortage of products essential to the health population in Brazil. This risk was also reinforced by the manifestations of actors within the sector (…)”.
In light of this context, RDC 810/2023, published in the Federal Register on august 18, 2023, included § 3rd, to art. 60 of RDC 751/2022:
- Art. 60. Notifications and records of medical devices, their amendments and other acts will be published in the Federal Register and will remain available for consultation on Anvisa’s website.
(…)
§ 3rd The importation of medical devices, including their accessories, whose industrialization dates precede the dates of publication of the notification or registration is permitted, provided that the time period does not exceed 5 (five) years, and that such products are strictly in accordance with the conditions approval from Anvisa.”
It’s important to emphasize that the expiry dates of the products must be respected and strictly follow the legislation in force.
Other hot topics are:
- RDC 810/2023 applies to the importation processes filed before Anvisa after June 18, 2023;
- The importer who falls into this category may present additional documentation in the import dossier for technical analysis of the Import Licenses – LI, which will be carried out by the General Management of Ports, Airports, Borders, and Customs Enclosures (GGPAF);
- For importation according to the new rule, administrative processes must be instructed with a statement issued by the notification or registration holder, ensuring that the time lapse between manufacture and the date of regularization does not exceed 5 years and that the products comply with the prior conditions of approval by Anvisa;
- For import processes filed before Anvisa from June 18, 2023, a period of 90 days will be granted, starting from the publication of RDC 810/2023, so that additional documentation may be presented.
RDC 810/2023 entered into force on the date of its publication.
For further assistance on medical devices current regulation, please do not hesitate to contact our Life Sciences & Healthcare team via email: lifesciences@soutocorrea.com.br .