RDC Resolution No. 591/2021 came into force on 10 January 2022. It requires Medical Devices regulated by ANVISA – the Brazilian Regulatory Authority – to be identified using the UDI (Unique Device Identification) system.
The resolution applies to all Medical Devices, except for custom-made Medical Devices and Medical Devices intended for clinical investigations.
RDC 657/2022 resolution on regulatory requirements applicable to software as Medical Devices (SaMD) which will come into force in July 2022 was published on 24 March.
UDI system: different risk classes, different transition periods
Before marketing a Medical Devices on the Brazilian market, it is now necessary for the Manufacturer to appoint a UDI code by placing it on the label and, when required, on all levels of packaging.
Please note that the UDI is the code composed of numeric or alphanumeric characters that allows the unambiguous identification of a specific device on the market.
As from 10 January 2022, the date of entry into force of CPR No. 591/2021, ANVISA has provided the following transitional periods for the allocation and application of the UDI:
- 2½ years for Class IV Medical Devices
- 3 years for Class III Medical Devices
- 4 years for Class II Medical Devices
- 6 years for Class I Medical Devices.
For reusable devices in which the UDI information is also placed on the product itself, an additional two years are added to the transition period indicated above for the respective risk class for the fulfilment of requirements.
Only for certain types of Medical Devices manufactured after 20 June 2020, such as coronary stents, drug–eluting coronary stents and hip and knee arthroplasty implants, the inclusion of the UDI code in the traceability labels mandatory as of 10 January 2022, when this Resolution came into force.
For the submission of information to the UDI database and the transmission of UDI information on adverse event notifications, complaints and field actions, the transitional period, referred to above, will begin when ANVISA will publish the Normative Instruction (NI) to declare that the Agency’s UDI database can receive UDI information. At the moment ANVISA has not yet stated when the Normative Instruction will be published.
New registration rules for software as a Medical Device (SaMD)
RDC 657/2022 Resolution published by ANVISA on 24 March 2022 focuses instead on the new requirements for the registration of software as Medical Devices (SaMD), for which the Brazilian Regulatory Authority had not previously issued specific rules.
Such requirements will come into force on 1 July 2022.
SaMD products registered with ANVISA will be subject to review, market monitoring, surveillance, and inspections by the Regulatory Authority. Furthermore, classification requirements established by RDC 185/2001 will also apply to SaMD.
Exceptions of SaMD to which the regulation does NOT apply
RDC 657/2022 does not apply to certain categories of SaMD, such as:
- Software for well-being of users
- SaMD already listed by ANVISA as a non-regulated product
- Software used only for administrative and financial purposes within healthcare organizations
- Software used to process demographic and epidemiological medical data without providing any diagnostic or therapeutic function
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DRC No. 591/2021, ANVISA, 21 December 2021