Overview
Under TECHNICAL NOTE No. 9/2023 from Anvisa, surgical masks and disposable hospital gowns are classified as medical devices and are subject to Anvisa notification for manufacturing, import, distribution, and marketing.
Notification Requirements
To notify a surgical mask or a disposable hospital gown, the applicant must:
- Proceed with the payment of the corresponding fee.
- Submit to Anvisa the following documents:
- I - Medical device approval form, duly completed, available on Anvisa's electronic portal.
- II - For imported medical devices: declaration issued by the legal manufacturer, consularized, written in Portuguese, English, or Spanish or accompanied by a sworn translation, valid for a maximum of two years when there is no express validity indicated in the document, authorizing the requesting company to represent and market its product(s) in Brazil.
In the notification form, the company must inform the specific technical standards and regulations used in the development and manufacture of the product.
In principle, in the notification, it is not necessary to present technical reports.
More information can be found in this link - file:///Users/lizethvillarreal/Downloads/SEI_ANVISA%20-%202260542%20-%20NOTA%20T%C3%89CNICA%20N%C2%BA%209.2023%20-%20aventais.pdf.