Establishment Registration definition

Establishment Registration means the registration that is required for each office, store, or location established or maintained for the dispensing of hearing aids in this state.

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Establishment Registration means registration with the FDA for the manufacture and distribution of products, including compliance with the regulatory requirements set forth in 21 C.F.R. 807.

Establishment Registration means each registration of Pharmacia’s facilities that is required by or with any Governmental Authority that has regulatory authority over the manufacture, development, distribution, marketing, promotion or sale of the Product, including the FDA, in connection with Pharmacia’s manufacture of the Product or the development, distribution, marketing, promotion or sale of the Product.

Examples of Establishment Registration in a sentence

• No such Product License or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, except where such untruth or omission could not reasonably be expected to have a adverse effect on the Business or the Purchased Assets.

• No such Product Approval or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

• No such Product License or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, except where such untruth or omission could not reasonably be expected to have an adverse effect on the Business or the Purchased Assets.

• Cambridge will maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and specifications developer for the Products, as is required by law or regulation.

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

• AM shall be responsible for the annual Establishment Registration Fee.

• This includes but is not limited to registering the UBS facility (ies) with regulatory authorities as required (e.g., US FDA Establishment Registration, Japan Foreign Manufacturer Authorization, etc.).

• These documents include, but are not limited to, the Mirage(TM) and Deltaloc(TM) 510(K) filings, Medical Device Reports (MDR's), recalls, market withdrawals, Establishment Registration and Service listings, Establishment Inspection reports including inspectional observations responses, FDA Form 483, and package inserts.

• In particular, but not by way of limitation of the foregoing, AYTU shall be responsible for payment of any FDA Drug Establishment Registration Fees associated with Biovest’s Development and/or Manufacture of Product in accordance with this Agreement and any Project Addendum executed hereunder.

• HJL shall maintain a Medical Device Establishment Registration (as defined under the Act) as Manufacturer of Record and Specifications developer for the Products, as is required.

More Definitions of Establishment Registration

Establishment Registration means the registration of the facilities used in the process of formulating, manufacturing, developing, packaging, marketing, distributing and selling the Products, as required under the Act and, if required by Law, the DEA and any applicable Governmental Authority.