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Anvisa’s new rules on the regulation of medical devices - Brazil

As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here), a regulatory update that would be compatible with the new reality and technological context of medical devices in Brazil has been expected for some time by society and, above all, by the main players in the digital health sector. 

Published on September 21 this year, the new Resolution of the Anvisa’s Collegiate Board of Directors (in Portuguese, “DICOL”) n. 751/2022 (“Anvisa’s Resolution n. 751/2022”) provides for the risk classification, notification and registration regimes, and labeling requirements and instructions for use regarding medical devices, aiming to update the rules that were previously insufficiently applicable to the matter through the now replaced Anvisa’s Resolution n. 185/2001.

The new rule corresponds to the Regulatory Project n. 11.14 of Anvisa’s Regulatory Agenda for 2021/2023 [“registration, alteration, revalidation and cancellation at Anvisa (Review of Anvisa’s Resolution n. 185/2001)”] and opportunely internalizes the rules provided by the Mercosur Technical Regulation for Registration of Medical Devices n° 25/2021 (“Mercosur Resolution GMC no. 25/2021”) – which, in its turn, updated the documentation requirements and classification rules for medical devices applicable to the region in line with international regulations and authorities such as the European Medicines Agency (“EMA”).

Among the main news brought by Anvisa’s Resolution n. 751/2022, we highlight: 

(i) the updates related to the definitions of medical device, as well as active medical device, active therapeutic medical device, active medical device for diagnosis and monitoring, surgically invasive device, single use medical device, implantable medical device, invasive medical device, in vitro diagnostic medical device and SaMD; 

(ii) the maintenance of the risk classifications already known by the market (i.e., class I and II medical devices – low and medium risk, respectively – subject to notification, and class III and IV medical devices – high and maximum risk, respectively –  subject to registration), as well as the adoption of specific classification rules for new technologies such as SaMDs and nanomaterials; 

(iii) the exemption of registration and notification for (a) medical devices intended for clinical investigations (with its marketing and use for alternative purposes expressly prohibited), (b) the presentations consisting of tow or more medical devices already notified and/or registered, and (c) the accessories manufactured exclusively to integrate medical devices already notified and/or registered; 

(iv) the requirement for insertion of the instructions for use in the Document Repository of Medical Devices (to be available at Anvisa’s website soon), as well as relating to information on labels and instructions for use (including in its unprinted format); 

(v) the adoption of a new structure of Technical Dossier in compliance with the International Medical Device Regulators Forum (“IMDRF”), allowing the use of dossiers prepared abroad, and only applicable when clinical evidence is required as a result of safety and performance demonstration, technological innovations and new indications of use; among other provisions related to: 

(vi) the formalization of the reevaluation procedure, (vii) the administrative penalties applicable to violators, (viii) the documents required for the procedures of notification, registration, re-validation and cancellation of notification and/or registration of medical devices, (ix) the situations of exhaustion of stock concerning finished products, packaging, labels and instructions for use, as well as (x) the Good Manufacturing Practices, which now become necessary for the granting and maintenance of the notification and/or registration of the regulated products.

It is worth mentioning that the new resolution does not apply to used or reconditioned medical devices, subject to the specific rules provided by Anvisa’s Resolution n. 579/2021; custom medical devices, subject to the specific rules provided by Anvisa’s Resolution n. 305/2019; in vitro diagnostic medical devices, subject to the specific rules provided by Anvisa’s Resolution n. 36/2015, and medicines, cells, tissues, organs, blood, cosmetics, sanitizers, or foodstuffs. 

Finally, regarding the indicated deadlines, we highlight that the new resolution will come into force on March 1st, 2023, and that all the registration petitions with a Technical Report Structure provided by the former Anvisa’s Resolution n. 185/2001 filed until February 28, 2023 will be accepted. 

Holders of notifications will have a period of one (1) year, from the entry into force of the new resolution, to file petitions for sanitary reclassification of products that had their regime changed from notification to registration due to the update of the classification rules, at the risk of cancellation of the notification, and conditioned to the publication of a valid Good Manufacturing Practice Certificate issued by Anvisa, as well as the fulfillment of the other requirements for medical devices registration. 

In an era where change is a new constant, the new normative act represents another advance by Anvisa towards the adherence to the new technologies for the life sciences and healthcare market – technologies that, in fact, shall be encouraged for the benefit of the Brazilian society and economy. It is therefore of utmost importance that players in the industry be aware of the new rules applicable to medical devices already present (or in the process to be) into the national market, so that they can develop their activities in a safe, efficient and aligned way with the best practices under the legal and regulatory perspectives. 

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