May 30, 2023
By Patricia Urakawa and Priscila Sanada
RDC 741/2022 and “identical” medical devices
For the first time ever, legislation was published in Brazil to permit leveraging authorization from regulators deemed equivalent. In August 2022, ANVISA published Resolution RDC 741/2022 (link in Portuguese), which set the framework to consider other medical device market regulators’ authorizations.
RDC 741/2022 explained that ANVISA would be able to use registrations from foreign regulatory agencies for identical devices (those considered to have the same intended use and same materials). ANVISA and other regulator(s) will exchange information to confirm the devices are identical. ANVISA will continue to require the documents already requested for a registration in Brazil (like labels and IFU in Portuguese).
At the most recent Hospitalar meeting (May 2023), ANVISA provided an update on their progress.
Proposed Reliance Registration
ANVISA expects to launch a new registration route, referred to as Reliance Registration/Optimized Analysis/Reliance Mechanism. The moniker for the new route has not yet been defined.
The new modality aims to reduce the approval time for device registrations in Brazil. The following conditions apply to this process:
- The new registration route would only apply to higher-risk Class III and Class IV products.
- Products could only be approved that have registrations in countries with agreements for the exchange of confidential information between health authorities.
While the regulatory authorities that ANVISA considers equivalent have not been defined, Medical Device Single Audit Program (MDSAP) participating agencies were noted as potential examples.
Qualifying Brazil AVISA applicants will be required to provide registration certificates issued by equivalent regulatory authorities. Companies applying via the new registration route will also need to verify that their devices submitted for ANVISA approval are identical to the devices listed on their registration certificates from equivalent regulators.
More details about this “Reliance Registration”
In order to keep the process for domestic Brazilian manufacturers similar to that for manufacturers able to leverage this new reliance registration, certain parts of ANVISA’s existing regulatory process will not change:
- The start of the registration process is the same.
- The requesting company will still need to file the registration request, using the existing registration submission routes.
- Upon receipt of the process number, the requesting company will then submit an amendment to request the analysis be carried out through the Reliance modality.
The objective of this new registration route is to speed up review timeframes by ANVISA technicians via leveraging the registrations of other countries.
Labeling still needs to be compliant to requirements in Brazil
Labeling (IFU, package label and device label) will continue to be required according to ANVISA’s rules, and submitted along with other required application materials.
This new modality does not grant automatic approval of qualifying devices in Brazil. The legislation is still being drafted, after which it will be presented as a Public Consultation.
ANVISA is still assessing which medical device regulatory jurisdictions may be leveraged under the new registration route.
Patricia Urakawa is Lead Quality & Regulatory Affairs Consultant and Priscila Sanada is RA/QA Regulatory Affairs Manager, Latin America at Emergo by UL.
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