10 Things You Should Know About the New Brazilian Regulation of Medical Devices | ANVISA RDC 751/2022

The new RDC (Resolution of the Collegiate Board) 751/2022 published by the Brazilian National Health Surveillance Agency (ANVISA) has just become effective on March 1st of 2023. Do you know what changed and what actions should be taken to keep your device marketed in Brazil? Here are 10 things you should know about it:

1. What was the purpose of the change?
   
   The main purpose of the change in the Brazilian regulation regarding medical devices (MDs) was to modernize it, making it possible to address new technologies that were not foreseen in the previous RDC 185/2001, such as software as medical devices (SaMD) and nanomaterials. In addition, the new RDC implements the MERCOSUL Resolution GMC 25/2021, agreed among Argentina, Paraguay, Uruguay and Brazil, and shows an effort of the Brazilian regulatory agency in harmonizing its concepts and required documents internationally, especially with the  International Medical Device Regulators Forum (IMDRF), formed by Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea, UK and US.
   
   
2. Which previous Resolutions are replaced by RDC 751/2022?
   
   The following Resolutions were replaced on March 1st, 2023, and therefore, are not valid anymore:
   
   I RDC 185/2001, which approved the Technical Regulation which dealt with the registration, alteration, revalidation, and cancellation of the registration of medical products.
   II RE 1554/2002, which reviewed the risk classification of active devices and electro stimulators for use in physical education, embellishment, and esthetic repair.
   III RDC 207/2006, which updated devices from RDC 185/2001.
   IV RDC 15/2014, which dealt with the requirements concerning fulfilling Good Manufacturing Practices for medical products.
   V Items I and II from Article 2nd and item II from Article 5th from IN 4/2012, which established rules for instruction for use for medical products in the non-printed format. 
   
   In addition, the regulation for devices for in-vitro diagnostics (IVDs) is under review. Once the update is effective, previous Resolutions which applied both for MDs and IVDs will also be replaced (full IN 4/2012, mentioned above, RDC 270/2019, which changed the regulatory regiment for class I devices, RDC 340/2020, which dealt with changing of information in the regulation process, RDC 403/2020, which allowed waiving sworn translation of documents written in English and/or Spanish, and RDC 431/2020, which dealt with uploads of IFUs in the ANVISA portal).
   
   
3. What products are in and out of the scope of RDC 751/2022?
   
   RDC 751/2022 applies to all medical devices that fall into its definition provided in the new regulation, which is very similar from the one from EU-MDR. Used or reconditioned medical devices, custom-made devices, devices for in-vitro diagnostics , drugs, cell, tissue, organ or blood from human origin or derivatives, cosmetics, sanitizing or food products for which there is specific regulation apart are out of the scope of the new resolution.  However, RDC 751/2022 will apply for active devices indicated for embellishment and esthetic repair and for active devices indicated for cleaning, disinfection, and sterilization of medical devices.
    
4. What were the major changes?
   
   The risk classification of medical devices was updated from Rules 1-18 to Rules 1-22. Now, there are specific rules for SaMD (rule 11) and for nanomaterials (rule 19). It is important that manufacturers review their device classification to check if there was any applicable reclassification, which will require readjustment. Definitions were also updated, attempting to harmonize with the EU Medical Device Regulation (MDR) and the IMDRF, as well as labelling requirements, including instructions for use (IFUs). In addition, procedures for notification, registration, alteration, revalidation, and cancellation of the registration of medical products were all modernized as well.
   
   
5. What are the most remarkable definitions updates by the new RDC? 
   
   The main definition change refers to how medical devices were called in Brazil: as much as they are usually translated as “medical devices,” only now this term is applicable in Portuguese. Before RDC 751/2022, they were called “produtos médicos para saúde”, which translates for “medical products for health.” This is a major change for the Brazilian manufacturers, and even ANVISA recognizes that it will a transition process for the documentation written in Portuguese. 
   From the new definitions, there is now a new legal entity, the “(Notification or Registry) Holder,” which is the responsible for the medical device in Brazilian territory and holds its commercialization after released by ANVISA. This legal entity is called Requester before device clearance, can be the manufacturer or the importer, and must be the one in the labelling. Therefore, as a consequence of this definition, it is a new requirement to have the (Notification or Registry) Holder recorded on the device labelling.
   The concept of “device part” was updated to “accessory,” the concept of “technical report” was changed to “technical dossier,” and the definition of medical devices was changed to closely align with MDR. In addition, new definitions were added to consider new technologies, such as SaMD, nanomaterial, agglomerate, aggregate.
   
   
6. What are the risk classes considered by ANVISA?
   
   ANVISA classifies the medical devices regarding to risk as following:
   I. Risk I – low risk.
   II. Risk II – medium risk.
   III. Risk III – high risk.
   IV. Risk IV – maximum risk.
   Rules 1-22 from RDC 751/2022 must be used for risk classification. As the risk classes were not updated but the rules were, manufacturers should be alert to the fact that it is possible that the risk classification of the devices has changed. If so, actions will need to be taken.
   
   
7. What are the different types of regulatory regiments available in Brazil?
   
   Medical devices from risk class I/II are submitted to ANVISA using the Notification process (“Notificação”), which requires that fewer documents are sent to the agency and does not need revalidation. However, those devices still must have the full technical dossier completed before submission, and it is subject to review under audit, and possible revocation of market. 
   Medical devices from risk class III/IV are submitted to ANVISA using the Registration process (“Registro”), which requires that the full technical dossier is subject for the assessment of experts with rounds of answers and questions. In addition, those devices must be revalidated every 10 years.
   
   
8. What is the structure of the documentation that should be provided to ANVISA? 
   
   The documentation should be provided to ANVISA in the technical dossier format, defined as “document which describes the elements that make up the device, indicating its characteristics, purpose, intended use, content, special care, potential risks, manufacturing process and additional information.”  Every information/documentation that should be in the technical dossier is presented in Chapter VII from RDC 751/2022. There is no template for the dossier, but ANVISA’s expectations align with the IMDRF/RPS WG/N9 (Edition 3) FINAL:2019 - Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC).
   All documentation can be provided in Portuguese, Spanish or English. Together with ANVISA’s attempt to harmonize its requirements internationally, it should allow manufacturers to present the same documentation from other markets, such as Canada, EU and US. However, the language in all labelling material and instructions for use must be Portuguese.
   
   
9. What actions are needed for new submissions?
   
   All new submissions from March 1st, 2023, on must completely follow RDC 751/2022. Changes to existing approvals will require only the update of the documents impacted by those changes.
   
   
10. What actions are needed for legacy devices? 
    

All legacy devices will need to update their labelling to identify the (Notification or Registry) Holder. This is an action that can (and should) be taken as soon as possible and is considered a non-reportable change. 

Manufacturers should review the device classification considering the new rules 1-22. If the device was registered before March 1st, 2023, and the device risk class remains the same, no additional action needs to be taken. If any Alteration is needed for those devices while their register is valid, there is no need to deliver an updated technical dossier to ANVISA, only the documents impacted for the alteration will be requested.
If the device risk class has changed, there are three possibles cases and applicable actions, which will be following presented. ANVISA must receive all changes/documentation until March 1st, 2024.

1. Change of risk class without modification of regulatory regiment.
    It refers to risk class changes from I to II, II to I, III to IV or IV to III. In those cases, the only immediate action to be taken, if applicable, is to review the Good Manufacturing Practices Certificate, to be sure that the manufacturing place is authorized for producing the updated risk class of devices. Other than that, the risk class update can be submitted to ANVISA in the first secondary petition, which can be for Alteration or Revalidation.
2. Change of risk class that modifies regulatory regiment from Register to Notification.
   It refers to risk class changes from III/IV to I/II, that means, a risk downgrade. In those cases, ANVISA should be notified of the change as soon as possible, via rectification protocol.
3. Change of risk class that modifies regulatory regiment from Notification to Registry.
   It refers to risk class changes from I/II to III/IV, that means, a risk upgrade. In those cases, ANVISA should be notified of the change via a reclassification/reframing protocol and receive a technical dossier for the devices with the same documentation requested for new registers.

Concluding remarks 

The new RDC 751/2022 is the result of a work that engaged regulatory and industry parties. ANVISA has taken an effort to harmonize the requirements and the requested documentation for registering medical devices in Brazil with other countries, especially the members of the IMDRF, MERCOSUL and EU. It also kept itself updated with the new technologies which were not foreseen by the previous RDC 185/2001, showing that the country is open for novel medical devices. Brazil is a huge market, and it is nice to see its regulatory agency is connected with the international updates for medical devices and mature to perform such important changes on time.

ANVISA, Gerência-Geral de Tecnologia de Produtos para Saúde, RDC Nº 751, de 15 de setembro de 2022
Classificação de risco, regimes de notificação e de registro e requisitos de rotulagem e instruções de uso de dispositivos médicos.

ANVISA, Gerência-Geral de Tecnologia de Produtos para Saúde, RDC Nº 751, de 15 de setembro de 2022
Classificação de risco, regimes de notificação e de registro e requisitos de rotulagem e instruções de uso de dispositivos médicos. Webinar from February 16th, 2023.

ANVISA, Gerência-Geral de Tecnologia de Produtos para Saúde, RDC Nº 751, de 15 de setembro de 2022
Classificação de risco, regimes de notificação e de registro e requisitos de rotulagem e instruções de uso de dispositivos médicos. Pergunatas e Respostas. 2nd Edition, March 2023.