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September 28, 2022

ANVISA approves new Resolution RDC related to Medical Devices

ANVISA published, in the Federal Official Gazette, RDC No. 751/2022, which provides and defines, in relation to medical devices, the (i) risk classification rules; (ii) labeling requirements and instructions for use; and (iii) the procedures for notification, registration, amendment, revalidation and cancellation of notification or registration. In other words, the new RDC will replace the old Resolution No. 185/2001, thus establishing a new regulatory scenario in the field of medical devices in Brazil. The new RDC will come into force on March 1st, 2023 and will also revoke, in addition to RDC No. 185/2001, Resolution RE No. 1554/2002; RDC No. 15/2014; and RDC No. 40/2015.

The new RDC brings a modernization of the regulatory text, updating of terminology and definitions, as well as aims to give greater clarity to the subject, joining all issues related to the regulation of medical devices in a single RDC.

The new RDC also provides for the Medical Devices Technical Dossier Structure to be aligned with the document issued by the International Medical Device Regulators Forum – IMDRF. In other words, the new text provides for the adoption of the structure of the Table of Contents of the IMDRF for technical dossiers, in order to allow the use of dossiers prepared for multiple jurisdictions.

It also included specific rules for new technologies, such as Software as a Medical Device and nanomaterials. In relation to nanomaterials specifically, the new RDC provides for the updating of risk classification rules, with the inclusion of Rule 19. This rule deals with the classification of devices that incorporate nanomaterials or consist of nanomaterials and in which Classes they must be classified (and may fall into Classes II, III or IV, depending on the potential for internal exposure).

Another novelty brought by the RDC is the possibility that, if there is a need to run out of stock of finished products as a result of an alteration, the simultaneous importation and commercialization of the versions involved can be allowed until the end of the validity period or useful life of the product. In addition, it is allowed to run out of stock of packaging, labels and instructions for use for a period of 120 (one hundred and twenty) days from the publication of the change.

Medical devices, object of this Resolution, remain classified according to the intrinsic risk they represent to the health of the user, patient, operator or third party involved, in Classes I (low risk); II (medium risk); III (high risk); or IV (maximum risk). In order to correctly classify the medical device into one of these classes, the classification rules established in the Resolution must be applied. Medical devices classified in risk classes I and II are subject to notification to ANVISA. Medical devices classified in risk classes III and IV are subject to registration. The period of validity of the registration of medical devices also remains for a time of 10 (ten) years, counted from the day of its publication in the Federal Official Gazette, and may be successively revalidated for an equal period.

It is important to note that RDC No. 751/2022 does not apply in the following situations:

  1. Used or refurbished medical devices, which are subject to the specific rules established in RDC No. 579/2021;
  2. Personalized medical devices, which are subject to the specific rules established in RDC No. 305/2019;
  3. Medical devices for in vitro diagnostics, including instruments for in vitro diagnostics, which are subject to the specific rules established in RDC No. 36/2015; and;
  4. Medicines, cells, tissues, organs or blood of human origin or derivatives, cosmetics, sanitizers or foodstuffs treated by other regulations.

The RDC provides the period of 365 (three hundred and sixty-five days), counted from the entry into force of the Resolution, for holders of notifications of medical devices to file petitions for sanitary reclassification of products that had their notification regime changed to registration due to the updating of classification rules. On the other hand, the registration processes whose products had their regularization regime changed from registration to notification due to the update of the classification rules will be dealt with by means of an ANVISA rectification file.

If you would like to be informed of further developments in this matter and/or need any assistance or clarification, do not hesitate to contact us at mail@kasznarleonardos.com.

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