What are Some Examples of Medical Devices Requiring Registration?
Manufacturer, distributor and/or retailer of medical devices must register. A medical device is an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat or prevent disease in man or animals. Some common examples of medical devices and facilities: Dental laboratories, dental equipment sellers, optical laboratories, eye glasses/contacts retailers, prosthetics sellers, orthotics sellers (specialized footwear/repairs/braces), dialysis equipment, hearing aid manufacturers and repairs facilities, etc. Note: Some devices contain prescription drugs or controlled substances. If a device contains prescription drugs then the business should register as a manufacturer, distributor or retailer of prescription drugs or controlled substances. Back To Top What if my Facility is Located Out-of-State? Registration is required if an out-of-state facility employs sales representatives within the Commonwealth. A current list of employees (name and addresses) may be submi
Manufacturer, distributor and/or retailer of medical devices must register. A medical device is an instrument or apparatus and parts and accessories used to diagnose, cure, mitigate, treat or prevent disease in man or animals. Some common examples of medical devices and facilities: Dental laboratories, dental equipment sellers, optical laboratories, eye glasses/contacts retailers, prosthetics sellers, orthotics sellers (specialized footwear/repairs/braces), dialysis equipment, hearing aid manufacturers and repairs facilities, etc. Note: Some devices contain prescription drugs or controlled substances. If a device contains prescription drugs then the business should register as a manufacturer, distributor or retailer of prescription drugs or controlled substances. Back To Top What if my Facility is Located Out-of-State? Registration is required if an out-of-state facility employs sales representatives within the Commonwealth. A current list of employees (name and addresses) may be submi
