The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are allowed to be placed on the market under simplified (notification) procedure providing that it is sufficient for the sponsor (the manufacturer, importer, distributor, supplier, or any other entity responsible for placing the device on the market) to notify the regulating authority, while any additional conformity assessment or validation is not required. Such a notification should be performed using a special form that can be downloaded from the ANVISA`s official website.
New Regulatory Approach
According to the regulations existing before the amendments described hereabove took place, the medical device manufacturers were obliged to submit a wide range of supporting documentation including technical files, labeling samples, and indications for use. Under the new framework, all the documents outlined above should be duly kept by the manufacturer to be provided to the authority upon request.
The new regulation provides the definition of notification. According to the document, the product notification is an act of communicating to ANVISA the intention to commercialize a medical product, intended to confirm the right to manufacture and import medical product exempted from registration pursuant to §1 of art.25 of the Law No. 6.360 dated 1976, and classified in risk classes I or II, with the indication of the name, manufacturer, purpose and other elements that characterize it.
Thus, the failure of the sponsor to provide additional documents (e.g. certificates or declarations) would not result in any refusal from the regulating authority. In the case of a family of the products, the general grouping rules could be also applied.
Notification Procedure for Class II Medical Devices in Detail
The new regulation also outlines the way the changes should be made for the medical devices placed on the market under the simplified framework described herein. In particular, the entity responsible for the medical device subject to changes shall submit the appropriate notification containing information about the changes made. The form of such a notification could be also downloaded from the official ANVISA`s website.
Another important point covered by the new regulation relates to the labeling and instructions for use. According to the document, both labeling and instructions for use accompanying the device should meet the general requirements applicable for the appropriate type (class under the risk-based classification) of medical devices. The additional requirement states that the labeling of a medical device placed on the market under the notification procedure should contain the ANVISA notification number.
The medical devices already marketed in Brazil under the previous framework are also exempted from revalidation. However, the sponsors still have to sustain compliance with the requirements prescribed by the Good Manufacturing Practices (GMP), as well as any other applicable technical standards and regulations. The initial registration number could be used as a notification number while the additional notification is not required, except the cases when certain changes to the products have been made.
It is important to mention that under the new regulation, ANVISA is entitled to cancel the notification in case if during the audit or inspection the authority would identify non-compliances or irregularities. The same rule should be applied in case of notification of changes contains any incorrect data. The notification could be also canceled upon request submitted by the sponsor itself in case if it is no longer intends to market the medical device in question in Brazil. At the same time, the cancellation of notification does not reveal the sponsor from its obligations regarding the devices already available to the patients and healthcare professionals.
Notification Framework Rules and Requirements
The regulation also outlines the rules and requirements related to the new notification framework that now becomes applicable for Class II medical devices as well.
One of the most important changes relates to the documents usually accompanying the registration submission. In this regard, the following key points should be considered:
- The sponsor is not required to submit the technical dossier when filing a notification. The document should remain in the company’s disposal to be provided to the regulating authority upon request.
- The same documents are not required when notifying ANVISA about the changes as well. According to the new rules, it would be sufficient to submit a special notification containing the description of the changes made to the device, while any additional information should be prepared and duly kept by the sponsor to be provided upon request.
- The scope of the regulation covers all Class I and Class II medical devices including in vitro diagnostic ones. Thus, for in vitro diagnostic medical devices, the same rules should be applied, including ones related to change notifications, labeling, and cancellation of notification.
- The labeling of medical devices placed on the market under the notification procedure should be in Portuguese or in a form of the appropriate symbols.
- The company attempting to place its medical devices on the Brazilian market under the notification procedure should be also exempt from the obligation to provide a free sale certificate issued in the country of origin. The same rule applies to the certificate of conformity – the absence of this document should not prevent the company from marketing its medical devices in Brazil providing that the appropriate notification has been duly filed to ANVISA. At the same time, the applicant company should be able to provide the aforementioned certificate within 180 days from the date the appropriate request becomes valid, while the failure of the company to provide such a certificate would actually result in the cancellation of the notification. In case if for some reason, the requested certificate could not be issued, the company is allowed to provide a consolidated report instead. Such a report should be based on test reports issued by testing laboratories. If the valid certificate of conformity expires during the period of validity of notification, the company shall provide a new certificate within 90 days while its failure to comply with this requirement could lead to the cancellation of notification. These rules are also applicable in case of medical devices already placed on the market in Brazil under the registration framework.
Summarizing the information provided here above, the new regulatory framework introduced in Brazil simplifies the procedures to be carried out when placing medical devices on the market. In particular, starting from September 17, 2020, Class II medical devices (including Class II in vitro diagnostic medical devices) are also eligible for notification procedure providing that the responsible entity could market its devices upon submission of the appropriate notification instead of registering the devices with ANVISA.
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