CLASS I “LICENSED” MEDICAL DEVICES

1 YEAR PROCESSING TIME

• Condoms
• Gloves, surgical and exam
• Syringes
• HIV test kits
• Contact lens (corrective and cosmetic)
• Injective Hyaluronic for defective skin (09/13/2019)

CLASS II “NOTIFIED” MEDICAL DEVICES 

6-8 MONTHS PROCESSING TIME

• Physical therapy equipment
• Alcohol detectors
• Methamphetamine Detectors
• Breast implants
• Opthalmic Viscoelastic Device
• Concentrate for haemodialysis (10/03/2017)
• Alcohol based sterilizer (09/13/2019)
• Alcohol gel sanitizer (09/13/2019)
• Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) (09/25/2018)
• Intense Pulsed Light (IPL) devices (pending)
• Automatic External Defibrillators (AED) (pending)
• Syphilis Screening Tests (pending)

CLASS III “GENERAL” MEDICAL DEVICE

2 TO 6 DAYS PROCESSING TIME (TYPICAL)

• All other medical devices
• Including dental equipment