November 8, 2023
Brazilian regulators have begun a public consultation and released more details regarding plans to recognize authorizations from foreign regulators for some medical devices.
Background on RDC 741/2022 and identical medical devices
RDC 741/2022 was released in August 2022 to acknowledge that the regulator in Brazil, ANVISA, would leverage registrations from foreign regulatory agencies for identical devices.
ANVISA provided an update at Hospitalar in 2023. This would be limited to Class III and Class IV devices and would only be applicable if the manufacturer had authorization with one of the countries recognized by ANVISA.
Consultation in September 2023
ANVISA posted a Public Consultation (Consulta Pública n° 1.200, September 1, 2023) with more details. There will be 45 days for the consultation. The legislation will be released as a normative Instruction applicable seven days after publication in the Diário Oficial da União.
As shared in May 2023, this would only be applicable to Class III and Class IV medical devices and IVDs (Chapter I, Section II, Article 2). The objective is described as an “optimized procedure for the analysis and decision of applications” for medical device registrations (Chapter I, Section I, Article 1) previously authorized in countries recognized as equivalent by ANVISA.
Further, the medical device could not have been subject to a recall, canceled authorization or suspended manufacture because of quality issues in the last three years (Chapter III, Article 7, III).
Consultation Document: Definitions like AREE
Chapter I, Section III, Article 5 of the Consultation document defined terms. The term Equivalent Foreign Regulatory Authority (Autoridade Reguladora Estrangeira Equivalente (AREE)) refers to the countries with which ANVISA has an agreement with (to exchange information) and which ANVISA considers as equal and thus willing to leverage an existing regulatory authorization.
Consultation Document: AREE countries/ countries recognized by ANVISA as equivalent
The AREE countries and regulatory authorizations are delineated in Chapter II, Article 6, I-IV. These are four of the five founding former Global Harmonization Task Force (GHTF) members.
- Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG)
- Canada: Health Canada (HC) – Medical Device License
- Japan: Japan Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin) from MHLW
- United States of America (USA): U.S. Food and Drug Administration (US FDA) – 510(k) or Premarket Approval (PMA)
Consultation Document: General requirements
All technical dossier documents and other documents required by RDC 751/2022 or RDC 36/2015 for medical devices or IVDs, respectively, are submitted as part of the initial registration submission.
To qualify for the AREE review, the documents required are described in Chapter IV, Section I, Article 8 (I-III)
- Signed declaration (Annex I template) by Technical Manager and Legal Responsible
- Evidence of authorization in AREE country (consularized or apostilled, plus sworn translation, if not in Portuguese, English, or Spanish)
- IFU for medical device in AREE (plus a sworn translation if not in Portuguese, English, or Spanish).
Once ANVISA’s review commences, ANVISA reserves the prerogative to require the medical device to register through normal procedures (Chapter IV, Section I, Article 9).
Emergo by UL monitors developments in Brazil and globally and will share information about this Normative Instruction in 2024.
This continues to be an exciting development, as it advances global harmonization and leveraging regulatory authorizations. Up until RDC 741/2022, Emergo by UL would not have expected Brazil to accept leveraged authorizations.
In addition, ANVISA has not identified compliance with the legislation in Europe (and CE marking) as an AREE region. We speculate that it was likely because of the challenge ANVISA would have with signing agreements with each European member state. Of course, note that an Australian ARTG listing can be predicated upon compliance in Europe and CE marking.
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