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Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices and/or medicated cosmetics must register with the Pennsylvania Department of Health unless otherwise noted as a designated exemption.
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),