From April this year, ANVISA implemented new rules for the classification of petitions for the alteration of medical devices. According to ANVISA, the measures, ruled by RDC 340/2020 and IN 61/2020, aim to define different categories for alterations on medical devices based on their risk, making clear which changes have to be previously reported. Thus, the measures aim to reduce technical analysis that are not necessary and speed up the assessment of requests by focusing on petitions associated to changes of greater complexity and risk, resulting on faster access to regularized medical devices.

Alterations, as defined by ANVISA, are changes on the information presented to ANVISA in the process of medical device’s registration. The new regulation classified those alterations in three categories, according to the type of change requested and the devices’ risk for health:

• Approval required Alterations
• Alterations with immediate implementation
• Non-reportable Alterations

Approval required Alterations

Alterations considered to be of greater health relevance, which deal with changes to be introduced in the regularization process, authorized only after technical document analysis and the issuance ANVISA’s approval.

Examples of approval required alterations are:

• Changes in the indication of use; type of operator or patient or use environment;
• Changes in the operation principle;
• Alteration or inclusion of resources;
• Addition of new models in a family;
• Alteration or addition of a new manufacturing unit in the Registro;
• Clinical performance;
• Manufacturing process, etc. 

Alterations with immediate implementation

Alterations classified as of medium sanitary relevance, that deal with changes to be introduced in the regularization process. Their implementation is authorized in the national territory upon petition protocol before ANVISA.

Immediate implementation changes will be published on ANVISA’s website, within 30 (thirty) days from the petition, regardless of document analysis.

Although the alterations with immediate implementation do not require ANVISA’s evaluation, the petition may be subject to documentary or technical assessment at any time and, if necessary, additional information or clarifications may be requested.

Examples of immediate implementation changes are:

• Change on the commercial name;
• Changes on contraindications;
• Adverse effects; warnings or precautions;
• Alteration or addition of a new manufacturing unit in the Notification or Cadastro;
• Company name for foreign manufacturers, etc.

The request for changes to Risk Class I medical devices will be carried out under the immediate implementation regime, except in the case of changes classified as non-reportable alterations.

Non-reportable alterations

Any other change of lesser sanitary relevance, resulting from a change that is not classified as required approval or immediate implementation, and that does not depend on a protocol at ANVISA for implementation.

Examples of non-reportable changes are:

• Non-technical changes such as images, formatting, layouts, symbols and text adaptations of documents without adding risk;
• Updates to Company Operation Authorization information;
• Changes to company contact and website;
• Alteration of technical assistance;
• Bug fixes in software, etc.,

Non-reportable changes must be controlled by the Brazilian Registration Holder’s Quality System, and be incorporated in subsequent petitions. 

Monitoring

According to the General Management of Medical Devices’ Technology (GGTPS), audits will be conducted focused on petitions for Alterations with immediate implementation. The goal will be to identify deviations and inconsistencies, working with companies to provide the necessary adjustments, when necessary. It is important to highlight that any alterations must comply with the rules of good manufacturing practices.

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DOMO Salute Team