Update to Medical Device Regulation Brazil, RDC No. 810, 2023

Authored by DENISE MCDERMOTT, senior Regulatory Compliance Specialist, Compliance & Risks

In August 2023, the Brazilian Health Regulatory Agency, published Resolution RDC No. 810, 2023, amending Resolution RDC No. 751 of 2022 which described labeling requirements and other instructions for use for medical devices. Resolution RDC No. 810, 2023 entered into force on its publication date, on 18 August 2023.

Resolution RDC No. 810, 2023

Resolution RDC No. 810 aims to regulate the requirements on importation of new medical devices. Specifically, this amendment adds further information to Article 60 of RDC No. 751, and states that medical devices and their accessories can be imported when their dates of manufacture precede their dates of notification or registration in Brazil. This is permitted provided the time passed does not exceed five years, and that such devices are strictly in accordance with ANVISA’s conditions of approval and in compliance with current legislation.

Moreover, the resolution states that import processes must be accompanied by a declaration issued by the notification or registration holder attesting to the fulfilment of all requirements. Importantly, the Resolution states that the provisions of this amendment apply to the import process filed with ANVISA from 18 June 2023.

For persons affected by this change, they may present additional documentation required under the terms of this Resolution for technical analysis and approval and the deadline for such is 16 November 2023.

Overall, this Resolution simplifies processes for medical devices companies, however, it is still crucial that imported medical devices continue to meet quality and safety requirements at all times.

References

Brazil: Labeling Requirements and Other Instructions for Use for Medical Devices, Resolution RDC No. 751, 2022 – Amendment – (on the importation of medical devices) Resolution RDC No. 810, 2023
Brazil: Labeling Requirements and Other Instructions for Use for Medical Devices, Resolution RDC No. 751, 2022

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