What is the process for the regularization of surgical gloves at ANVISA?

The process of regularizing surgical gloves at ANVISA involves several specific procedures. Here are the main necessary steps:

Registration with ANVISA: The manufacturer or importer must be registered with ANVISA to carry out the notification process. This involves providing information about the company and its activities.

Preparation of the Notification Dossier: The manufacturer or importer needs to prepare a technical dossier containing detailed information about the surgical gloves, including their composition, manufacturing characteristics, safety and efficacy studies, and other relevant data.

Completion of the Notification Form: The specific notification form for surgical gloves provided by ANVISA must be completed, providing all requested information accurately and completely.

ANVISA Review: ANVISA will conduct an analysis of the submitted notification dossier and form, verifying if all information is in compliance with applicable standards and regulations.

Maintenance of Compliance: After notification, the manufacturer or importer must maintain product compliance with applicable standards and regulations and be subject to audits and monitoring by ANVISA.

It is important to note that the details and specific requirements may vary according to current legislation and ANVISA guidelines, so it is essential to consult the agency directly for up-to-date and accurate information on the notification process for surgical gloves.

The difference between a notified product and a registered product with ANVISA lies mainly in the procedures and types of products involved.

Notification by ANVISA: This process applies to low-risk health products such as cosmetics, personal hygiene products, sanitizers, some foods, among others. Generally, notified products are those with formulations and ingredients already recognized and accepted by regulatory authorities.

The notification process tends to be simpler and faster than the registration process. The manufacturer or importer only needs to notify ANVISA about the production or importation of the product, providing information about its composition, manufacturing, and safety.

Registration with ANVISA: This process is required for products considered of medium and high risk to health, such as medicines, medical equipment, in vitro diagnostic products, among others.

Registration involves a more detailed analysis of the product's technical, safety, and efficacy data, as well as clinical trials and stability studies, depending on the product category.

The registration process is more complex and time-consuming than notification. The manufacturer or importer must obtain formal authorization from ANVISA before commencing the commercialization of the product in the Brazilian market.

In summary, while notification is used for low-risk products, registration is necessary for medium and high-risk health products, with more rigorous and demanding regulatory processes.

Surgical gloves are notified to ANVISA due to their low health risk and their classification as Class I medical devices. This is because they are temporary use, have a low potential for causing harm, and are intended to protect healthcare professionals and patients during surgical procedures. This notification process is more streamlined and agile than registration because surgical gloves are considered low risk and follow specific regulatory standards for Class I medical devices.

If you are seeking information about the regularization of surgical gloves at ANVISA and don't know where to start, contact the specialized team at Stone Okamont. We have the necessary knowledge to help you regularize your product. Contact Stone Okamont today.