Legal Manufacturer definition

Legal Manufacturer means the Person with legal authority to design, manufacture, package and label a product or device before it is placed on the market, regardless of whether these operations are carried out by that Person itself or on its behalf by another Person.
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Legal Manufacturer means the manufacturer of a medical device in the meaning of the German Medical Devices Act (Hersteller), Directive ·98/79/EC and other Applicable Laws, i.e. the natural or legal person who is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a Third Party.
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Legal Manufacturer means the “legal manufacturer” as defined by Applicable Law.
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Examples of Legal Manufacturer in a sentence

  • If Seller is the Legal Manufacturer for finished goods, Seller shall be responsible for making all filings and reports of an Adverse Event relating to Products with Regulatory Authorities.

  • The Legal Manufacturer or Reseller must supply the testing laboratory with a full duplicate set of the Product Dossier already supplied to WHO in accordance with the requirements of specification clause 7.

  • EyePoint shall own and maintain all regulatory filings and Registrations for the Products in its own name, shall be the Legal Manufacturer of the Products, and shall be responsible for and act as the sole point of contact with the applicable regulatory authorities in connection therewith.

  • This model of surveillance is offered to parents as a positive intervention in family life: the app promises to “let you know if they’re getting the rest they need” and “[c]onnect with your loved ones on your health and fitness goals” (Fitbit “Ace”).

  • Centogene shall act as the Legal Manufacturer of the Contract DBS Test Kits and shall, subject to the provisions hereunder, solely bear all related legal and regulatory responsibility as the Legal Manufacturer of the Contract DBS Test Kits under Applicable Laws in the Territory as set forth under this Agreement.

  • Definition of Legal Manufacturer – Article 1 of MDD and IVDD, AIMD‘Manufacturer´ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

  • Centogene shall release and place on the market the Contract DBS Test Kits in accordance with the Specifications, Applicable Laws and Standards as the Legal Manufacturer under its own name in each country of the Territory.

  • Centogene will release and place on the market the Contract DBS Test Kits manufactured by Centogene in accordance with the Specifications, Applicable Laws and Standards as the Legal Manufacturer under its own name.

  • Supplier agrees that it will provide the following information to Xxxxxx Scientific with respect to each Health Canada regulated Product: 1) Health Canada Medical Device License number 2) Health Canada medical device classification (I, II, III, IV) 3) Device description 4) Name and Address of the Legal Manufacturer.

  • Record general comments and recommendations for each section.• Step 4: Take a three quarter view digital photograph of each of the demonstration samples.• Step 5: Obtain any additional supporting information required in writing from the Legal Manufacturer or Reseller and attach this information to the report.Acceptance criteria: Inspection indicates full conformity with all major specification requirements, subject to acceptable restrictions on temperature zones2 and region(s).


More Definitions of Legal Manufacturer

Legal Manufacturer means the party registered with the FDA as the manufacturer of the Product, which coincides with the US Regulatory Transfer.
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Legal Manufacturer means the manufacturer of a medical device under Applicable Laws, i.e., the natural or legal person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a Third Party. ​​
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Related to Legal Manufacturer

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Manufacturer means the person or body responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle which is the subject of the approval process.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Engine Manufacturer means CFM International, Inc.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Authorized aftermarket manufacturer means an organization that fabricates a part under a contract with, or with the express written authority of, the original component manufacturer based on the original component manufacturer’s designs, formulas and/or specifications.

  • Participating manufacturer means that term as defined in the master settlement agreement.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • API means the American Petroleum Institute.

  • Drug store means a place whose principal business is, the

  • Original equipment manufacturer means a company that manufactures products that it has designed from purchased components and sells those products under the company's brand name.

  • MANUFACTURERS means M/s and shall include their legal representatives, successors, and assigns.

  • Successor manufacturer means a manufacturer that acquires, succeeds to, or assumes any part of the business of another manufacturer as the result of any of the following:

  • City-based manufacturer means a person who: (i) holds any appropriate city license; (ii) is subject to applicable city taxes; and (iii) owns, operates, or leases a manufacturing facility within the city.

  • Distributor means a person who distributes.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Distillery manufacturing license means a license issued in accordance with

  • Motor vehicle manufacturer means any of the following:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Nonparticipating manufacturer means any tobacco product manufacturer that is not a participating manufacturer.

  • Medical marijuana means marijuana that is grown, processed, dispensed, tested, possessed, or used for a medical purpose.

  • Non-Participating Manufacturer means any Tobacco Product Manufacturer that is not a Participating Manufacturer.

  • Manufactured good means a good brought to the construction site for incorporation into the building or work that has been--