ANVISA published, on the 9^th of October, Technical Note nº 218/2020 updating the list of products that are exempt from regulation by the Agency. Some of these products were included in the list of low risk health products (class I) subject to registration. However, considering that they did not fit the definition of medical devices according to RDC nº 185/2001, and ANVISA reported constant questioning about the proper classification of those devices, they have been removed.

According to Resolution No. 185/ 2001, a medical device is a health equipment, apparatus, material, or system of medical, dental or laboratory use, designed for the prevention, diagnosis, treatment, rehabilitation or conception and which do not uses pharmacological, immunological or metabolic means to perform its main function in human beings but can be assisted in their functions by such means.

Therefore, ANVISA included 33 new items to the list, and informed that those which had been previously registered will be cancelled. Some of the products are:

• Pliers and scissors for cutting nails;
• Wheelchair cushions, except for ulcer prevention;
• Bib for dental use;
• Trays / Boxes / Cases, including for sterilization (Labels to identify boxes / racks);
• Pen for surgical marking;
• Device that destroys and disables a medical device / counter (needles, scalpels, and others);
• Packaging for sterilizing medical products;
• Organ transport and storage packaging;
• Canvas / device / field for patient transfer;
• Gloves with no indication of health use;
• Nipple protector;
• Patient identification bracelets (including mother-child bracelets) and risk classification bracelets,
• Restrictors used to contain the patient;
• Disposable hospital bedding;

The full list contains 9 categories of products and is available here.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team