Overview:
Brazil’s Anvisa updated regulation for medical devices RDC 830/2023, which deals with risk classification, notification, and registration regimes, as well as labelling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments, will be implemented from June 1st,2024.
The publication of RDC 830/2023 resulted in several changes to the regulation of in vitro diagnostic medical devices.”
Introduction:
The Collegiate Board Resolution (RDC) 830/2023 will come into force in June 2024, updating the rules on medical devices for in vitro diagnostics (IVD).
This standard, to be implemented starting first of June 2024, addresses various aspects, including risk classification, procedures for notification, registration, amendment, revalidation and cancellation of notification or registration, as well as the labelling requirements applicable to these medical devices.
The new RDC aims to align the Brazilian regulatory scenario with international practices, updating definitions and risk classification rules. It also seeks to provide greater clarity on the subject, consolidating the main issues related to the regulation of in vitro diagnostic medical devices in a single resolution.
The main changes introduced by Collegiate Board Resolution (RDC) 830/2023 include:
- Risk Classification: Review and updating of risk categories for in vitro diagnostic medical devices, following international standards and considering the complexity and risk potential of each device.
- Notification and Registration Procedures: Establishment of clear and specific procedures for notification, registration, amendment, revalidation and cancellation of notification or registration of in vitro diagnostic medical devices.
- Labelling Requirements: Definition of more detailed and rigorous requirements for the labelling of medical devices, guaranteeing accurate and complete information for end users and healthcare professionals.
- International Alignment: Seeking alignment with international regulatory practices, promoting greater harmonization, and facilitating international trade in these devices.
- Consolidation of Regulations: Concentration of the main guidelines and regulatory requirements related to in vitro diagnostic medical devices in a single resolution, making it easier for manufacturers, importers, and other interested parties to understand and apply the rules.
These changes are aimed at improving the safety, efficacy, and quality of in vitro diagnostic medical devices, as well as providing a clearer and more predictable regulatory environment for the stakeholders involved.
Deadline for holders of notifications or registrations:
- Starting from June 1st, 2024, holders of notifications for in vitro diagnostic medical devices will have a period of 365 days to submit petitions for the sanitary reframing of products whose notification regime has been changed to registration due to the updating of the classification rules.
- The registration processes for products whose regularization regime have been changed from registration to notification due to the updating of the classification rules will be dealt with by means of a rectification file.
- Situations in which there is a change in risk classification without a change in health regime (notification/registration) will not require new applications from companies.
Conclusion
The changes introduced by RDC 830/2023 represent a significant milestone in the regulation of in vitro diagnostic medical devices in Brazil. By updating the rules on risk classification, registration, and notification procedures, labelling requirements and instructions for use, the new resolution seeks to ensure greater safety, efficacy, and quality for these devices.
In addition, by aligning itself with international regulatory practices, RDC 830/2023 facilitates international trade and promotes regulatory harmonization. Consolidating the guidelines into a single resolution also provides greater clarity and simplicity for manufacturers, importers, and other interested parties.
It is important to note that the changes implemented by RDC 830/2023 will require adaptation on the part of companies in the sector, especially regarding notification and registration procedures, and the sanitary re-framing of products. However, these adjustments aim to improve the regulatory environment, strengthening the safety and efficacy of in vitro diagnostic medical devices available on the Brazilian market.
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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.