QR Group provides guidance to international manufacturers on new regulatory requirements for in vitro diagnostic devices and how to adapt to RDC 830/2023
ANVISA will carry out an important update to its electronic petitioning system between May 29 and June 3 to comply with RDC 830/2023, which establishes new rules for the risk classification, registration, notification and labeling of in vitro diagnostic medical devices, including associated instruments.
This update may temporarily impact medical device manufacturers, especially those who intend to submit petitions related to subject codes in the in vitro diagnostic area. QR Group, a specialist in health product regulation in Brazil, is prepared to guide international companies on the changes and ensure that their products comply with the new requirements.
Main changes introduced for In Vitro Diagnostic Devices in RDC 830/2023:
RDC 830/2023 includes new requirements for the notification and registration of in vitro diagnostic medical devices, directly affecting the way manufacturers need to prepare their documentation for submission to ANVISA. The most relevant changes are:
- Improved risk classification, with new definitions that affect the degree of regulation of each device.
- Changes to the instructions for use and labeling, ensuring that the information provided to the end user is clear and accurate.
- Revision of the notification and registration regimes, optimizing the evaluation process by ANVISA.
During the transition, the following petition codes may be temporarily unavailable:
- 8007 – IVD – Change of registration (Immediate implementation – Commercial name of product)
- 8008 – IVD – Change of registration (Approval required – Composition of products or models of instruments)
Check all the changes here.
How can QR Group help?
For international manufacturers targeting the Brazilian market, it is crucial to adjust their submissions in accordance with ANVISA’s new requirements. QR Group, with its extensive experience in regulatory consulting and aligned with the latest legislative updates, offers complete support during this phase. From preparing documentation to monitoring the electronic petitioning process, our team ensures that your product will be successfully submitted, avoiding delays and compliance issues.
With a proven track record of helping companies navigate ANVISA’s complex regulations, QR Group is your trusted partner to ensure the efficient and secure registration of your medical devices in Brazil.
Conclusion
With RDC 830/2023 coming into effect, it is essential that manufacturers of in vitro diagnostic medical devices are ready to adapt their registration processes. QR Group is prepared to assist international companies in ensuring that their submissions are 100% compliant with the new regulations.
If you need assistance submitting your devices to ANVISA or to better understand RDC 830/2023, contact QR Group. Our team of experts is ready to help your company meet all regulatory requirements safely and efficiently.
Glossary:
IVD: In vitro diagnostic medical devices, which analyze biological samples outside the body.
RDC 830/2023: ANVISA resolution that regulates the registration and notification of in vitro diagnostic medical devices.
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Source:
ANVISA – https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/assuntos-relacionados-a-dispositivos-medicos-para-diagnostico-in-vitro-passarao-por-atualizacao
