The brazilian resolution RDC No.751/2022 Dispõe sobre a classificação de risco, os regimes de notificação e de registro, e os requisitos de rotulagem e instruções de uso de Dispositivos Médicos on Medical Devices, defines risk classification requirements, notification and registration regimes and the requirements of labelling and instructions for the use of Medical Devices effective March 1, 2023.

The measure incorporates Mercosur Resolution No. 25/2021 and unifies the various regulatory provisions issued by Anvisa previously in one text.

Aesthetic equipment and equipment intended for the cleaning, disinfection or sterilisation of Medical Devices are also included among Medical Devices, and therefore covered by the resolution.

On the other hand, Resolution No. 751/2022 does not apply to reused or reprocessed Medical Devices, custom-made devices, in vitro diagnostic Medical Devices including instruments, medicines, cells of human origin, human tissues, organs or blood or its derivatives, cosmetic products, sanitisation products or foodstuffs, for which other legislation is in force.

There are a number of important elements that may critically affect the product or system compliance of the manufacturer marketing Medical Devices in the Brazilian market. Among the most impactful topics are:

  • general update of the classification rules for Medical Devices and inclusion of new definitions;
  • implementation of specific classification rules for new technologies (e.g. software and nanomaterials);
  • consolidation and unification of rules previously laid down in other resolutions on notifications, registrations and variations;
  • usage rules of instructions for use in electronic format;
  • management of out-of-stock situations for finished products, packaging, labels and instructions for use.

With the RDC Resolution No. 751/2022 and the process of updating and reorganising its contents into a single text, Brazilian legislation on Medical Devices aligned with international requirements, particularly European ones. The advantage of this rapprochement for organisations interested in local marketing is obvious: the exchange of information and application management with the Regulatory Authorities is expected to improve, as well as greater agility in meeting regulatory requirements.

>>> Through strategic-regulatory consulting  services, registration support at Anvisa, and the Brazilian Registration Holder service, Thema can support you in fulfilling Brazilian regulatory requirements.

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