February 3, 2023
By Luiz Levy and Evangeline Loh
Effective March 1, 2023, the technical dossier must be structured as described in Brazilian medical device regulation RDC 751/2022. We wrote before that RDC 751/2022 replaced RDC 185/2001 for medical device classification and the regulatory regimes, Notificação (Class I and II devices) and Registro (Class III and IV devices). In our classification discussion, we had recommended that the manufacturer consider European guidance. In the interest of completeness, Brazil’s medical device market regulator ANVISA published on February 1 (and revised on February 2) a FAQ to RDC 571/2022. In Section 4.2, ANVISA’s responses to some classification questions are questions 11-16.
The technical dossier or dossiê técnico is described in Articles 4, 57 and 58, and in Annex II. The technical dossier is defined (Article 4, Section XVIII) as the regulatory document which presents the medical device, characteristics, purpose, mode of use, potential risk, manufacturing process and additional information. Chapter VII is dedicated to the technical dossier.
Article 57 I-VII describes some of the requested elements in the technical dossier. Annex III.A, III.B, and III.C from RDC 185/2001 have been deleted. Chapter 6 includes the requirements for labeling.
The organization of the submission is presented in a Table (Annex II). This is aligned with the International Medical Device Regulators Forum (IMDRF) guidance. The submission must now be organized according to IMDRF/RPS WG/N9 (Edition 3) FINAL:2019 - Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC). There are six chapters. (The table also specifies if the information is relevant based on the risk of the device: in the interest of disclosure, this is not all that interesting as only three items are not relevant, and not relevant to Class I devices.)
Annex II, Chapter 3 requires the List of Essential Security and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho), a reminder that the device must be compliant to RDC 546/2021.
For those expert with compilation of European MDR Technical Documentation Files or IMDRF-compliant documents, this should be a similar experience, however of course with knowledge specifically on device grouping and other Brazil legal requirements. ANVISA guides manufacturers in the FAQ to include respective files in each chapter. And, separate files for each item may be necessary. Further, in order to harmonize compilation and review, ANVISA will soon publish guidance.
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