Medical devices and accessories

This help page covers medical devices and accessories. A medical device is an instrument, apparatus, machine or related object used to diagnose, cure, treat, or prevent.

Some medical devices may be sold to general consumers, while others are professional-use and prescription only (Rx) devices that may only be sold to licensed healthcare practitioners.

The Brazilian Health Regulatory Agency (Anvisa) regulates medical devices. Anvisa is the Brazilian federal agency that is responsible for ensuring that medical devices intended for human use are safe and effective.

Please use the checklist below to ensure that your product complies with Anvisa requirements and can be sold on Amazon.com.br.

Compliance Checklist for Medical Devices and Accessories

Registration, Clearance, and Approval

1. Owners or operators of facilities that are involved in the importation, production and distribution of medical devices intended for use in Brazil must bear AFE issued by ANVISA
2. Sellers must bear a local sanitary license.
3. Medical devices must be either notified to or registered with Anvisa depending on the class of risk (I, II, III and IV).
4. Medical devices must not have been the subject of any recall by Anvisa.
5. Some medical devices must be Inmetro certified.

Labeling

1. All medical devices must be labeled in Portuguese with the following information:
   
   1. The name and place of business of manufacturer, packer, or distributor, including the street address, city, state, zip code and CNPJ
   2. Directions for use
   3. Registration number with Anvisa

Marketing

The requirements below apply to all product marketing materials, including the product detail page, product packaging, and any instructional materials or package inserts included with the product.

• Medical devices must not make false or misleading statements.

Examples of permitted listings

• Medical devices for lay use that are not otherwise restricted and are appropriately described and labeled, such as:
  • Adhesive bandages
  • Crutches
  • Otoscopes
  • Personal Sound Amplification Products (PSAPs)
  • HIV self-test
  • Glycosometer
  • Thermometers

Examples of prohibited listings

1. Products that are labelled for professional or prescription use only, such as (this is a non-exhaustive list):
   • Implantable devices, such as pacemakers
   • Infusion set
   • Laser combs
   • Defibrillators
   • Oral cavity abrasive polishing agents
   • Oxygen concentrators, compressors, conservers, generators, condensers and their accessories
   • Resin tooth bonding agents
   • Seizure bite sticks
   • Skin glue
   • Surgical kits
   • Surgical sutures
   • Ultra sound therapy and ultra sound pain relief devices
   • Ventilator machines
   • Electrodes
   • Dental implants
   • IUD
   • Stents
2. Irregular and/or illegal products
   
   1. Products that contain mercury, such as thermometers and batteries
   2. Used and refurbished medical devices
   3. Products that are adulterated or misbranded
   4. Products not registered with Anvisa

Additional useful information

• Anvisa Health Products home page
• Anvisa search page on registered Medical Devices
• Database of medical devices regular with Anvisa