Omega CHB is nationally licensed to clear freight at all airports and ocean ports with the United States. We are here to help you navigate through the labyrinth of regulations regarding the importation of medical devices, such as ventilators, bandages, face masks, wheelchairs, stethoscopes, beds for hospitals, etc. We know which government parties are involved, regulations that need to be followed and the fundamental aspects of importing medical supplies.
All medical devices will fall into three classes and must meet all FDA regulations prior to being imported into the US.
- Class I: General Controls | These devices are not intended to support life or prolong life or be significantly important in preventing harm to human health
- Class II: General Contro with Special Control | These devices are designed to perform as indicated without causing injury or harm to patient or user, such as motorized wheelchairs, infusion pumps, and surgical drapes.
- Class II: General Controls, Special Controls, and Premarket Approval | These medical devices shows that there is not enough information present to assure safety and usefulness. These devices require premarket approval, a scientific overview to ensure the device’s safety and usefulness.
Omega has experience in and takes great pride in working with the following medical supplies
Medical Supplies
- surgical face masks
- N95 face masks
- Disposable Nitrile Gloves
- Disposable Gown
- Isopropyl Alcohol 70%
- Isopropyl Alcohol 90%
- Hand Sanitizer
- Face shield
- Goggles/Safety glasses
- Povidone Iodine Swabsticks
- Alcohol Cleanising Pad
- CPR Mask
- Ace Bandages
- Antibiotic Ointment
- Bacteriacides
- Band-aids
- Bandages, abdominal, non-adherent, plaster, pressure, transparent
- Betadine, bottle, swab
- Blood Glucose Monitor
- Blood Glucose Lancets
- Blood Glucose Strips
- Blodd Pressure Cuff
- Bulb Syringe
- Burn Dressing
- Casting materials
- Catheters, foley, straight, external urinary, suction, angio
- Chest Tubes
- Cotton Tipped Applicators
- Crutches
- Dental Instruments
- Drapes or Sterile Fields
- Dressings, duoderm, non-adherant, transparent, Vaseline,
- Endotracheal tubes
- Eye Pads
- Gauze
- Gloves, non-sterile exam
- Heme-Occult Kit
- Irrigation tray
- IV Catheters, 14g, 16g,18g, 20g, 22g, 24g
- Lancets
- Needles, assorted gauges
- Ob/Gyn supplies
- Oxygen masks
- Packing strips
- Scalpels and blades
- Sharps containers
- Specimen containers
- Suture, non-absorbable and absorbable
- Syringes, assorted sizes
- Thermometers
- Tongue depressors
- Urinary catheters
- Urine drainage bags
Additional Resources
Information on importing medical supplies to the U.S. can be found on the FDA website: https://www.fda.gov/Medical-Devices.
Additional information on medical device overview can be found on the FDA website: https://www.fda.gov/industry/regulated-products/medical-device-overview#What%20is%20a%20medical%20device