Medical Device Product definition

Medical Device Product shall have the meaning ascribed to such term in Section 3.1(hh).
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Medical Device Product shall have the meaning ascribed to such term in Section 3.1(jj). “Pre-Notice” shall have the meaning ascribed to such term in Section 4.11(b). “Pro Rata Portion” shall have the meaning ascribed to such term in Section 4.11(e).
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Medical Device Product means a Product for which Ocera has obtained Regulatory Approval as a medical device (as opposed to as a pharmaceutical drug).
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Examples of Medical Device Product in a sentence

  • D.O.O. will send UDFRM.07 M Medical Device Product Certification Contract.

  • If Buyer commercializes any Medical Device Product and thereafter Seller exercises its Right of Reversion, Seller shall grant to Buyer upon Buyer’s request a license to continue to commercialize such Medical Device Product.

  • The Parties expressly acknowledge and agree that as of the Effective Date, Virpax intends to develop a Drug Product and does not intend to develop a Medical Device Product.

  • This guidance document must be read in conjunction with the ASEAN CSDT document, the GN-15 Guidance to Medical Device Product Registration and other relevant guidance documents.

  • Registrants are advised to refer to the GN-15 Guidance on Medical Device Product Registration for details on the data requirements for the evaluation routes.

  • Nanomerics expressly acknowledges and agrees that the decision to change regulatory pathways is solely within Virpax’s discretion and, notwithstanding anything to the contrary hereunder, Virpax is under no obligation to develop a Medical Device Product.

  • Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Guidance for Industry and Food and Drug Administration Staff(12/27/2016) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidance Documents/UCM50667911.

  • Either party may terminate this Agreement at the end of a 90-day period following Synergetics’ receipt of written notice from CODMAN if a judgment from a court of competent jurisdiction in the United States holds that the manufacture, use, importation or sale of a Medical Device Product, which has not been discontinued or otherwise removed from Schedule A, infringes the patent rights of a third party.

  • For example one large firm (see MATCH deliverable “Report on Medical Device Product Development Processes: Some Illustrative Examples”) leaves project planning and staff involvement at the discretion of the project leader.

  • Rationale for using ISO 16506 (Chapter A 2.2.5) as test standard The Medical Device Product Classification for the stated product is KLE (Agent, Tooth Bonding, Resin).

Related to Medical Device Product

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

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

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;