Medical Device Establishment Registration Clause Samples

Medical Device Establishment Registration. GBI shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and Specifications developer for the Products, as is required.

Medical Device Establishment Registration. During the term of this Supply Agreement or as required by law, which ever date is later, HJL shall continue to maintain a Medical Device Establishment Registration and Listing (as defined under the United States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, as amended from time to time (the “Act”)) as the contract manufacturer.

Medical Device Establishment Registration. Ivivi shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and Specifications developer for the Product, as required by law, including without limitation those defined by 21 CFR Part 807. If Ivivi is not the manufacturer of the Product and is using a third party to manufacture the Product, then such third-party manufacturer shall maintain the Medical Device Establishment Registration as required by law and the foregoing sentence and Ivivi shall ensure compliance with such requirement. In any event, Ivivi shall keep Allergan informed of, and obtain Allergan's prior written approval (which shall not be unreasonably withheld) prior to, any modifications to the manufacturing process and/or the specifications for the Product.

Medical Device Establishment Registration. Novare shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and specifications developer for the Products, as is required.