International Regulatory Agency definition

International Regulatory Agency means any national, provincial, state or local governmental agency or other organization outside of the United States which performs functions similar to the FDA.
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Examples of International Regulatory Agency in a sentence

  • The X-Ray product should be comply with all applicable US FDA & equivalent International Regulatory Agency requirements, contained in the cabinet X- ray radiation safety performance standard ( 21 CFR 1020.40 ) & general performance standard ( 21 CFR part 1010 ).

  • Several of the disqualification decisions issued by the Washington Court of Appeals this year were unpublished—but are readily available in electronic form.

  • During the term of the Agreement, interaction with the FDA, any International Regulatory Agency and any other similar authority within or outside the United States concerning Neoprobe Products shall be conducted exclusively by Neoprobe.

  • At the end of the implementation period, the client-hired local firms, Agora consulting and Etudes et Réalisations Economiques (ERE) pour le Développement, to assess the impact of the AIMDP.

  • Except as provided for in Section 5.3, OrbusMT shall institute and fund any recall, corrective action, or the like in circumstances relating to a R Stent defect or failure which requires such action as determined by the FDA, any International Regulatory Agency, OrbusMT, or as otherwise may be required pursuant to applicable laws, rules or regulations.

  • In the event of a dispute between USSC and SPNC concerning any matter relating to such interaction with the FDA or any International Regulatory Agency solely as it relates to the Field, USSC shall have final authority to act, as USSC in its sole discretion, deems appropriate with respect to the matter in dispute.

  • As an example, the indiscriminate inflow of external resources into a country, in a short period of time, through the relaxation of rules of the digital economy, by decision of the International Regulatory Agency, may stem from geopolitical interference from other countries.

  • Notwithstanding the foregoing, nothing in this Agreement shall restrict (i) SPNC's right to conduct itself appropriately as determined in the exercise of SPNC's sole judgment with respect to any regulatory agency, including, without limitation, the FDA and any International Regulatory Agency, or (ii) SPNC's ability to conduct research and academic studies including, without limitation, clinical trials concerning Excimer Lasers and Probes.

  • In your reply brief, you may not include new arguments in support of your motion.

  • Spectranetics shall institute and fund any recall, corrective action, or the like in circumstances relating to an R Stent defect or failure which requires such action as determined by the FDA, any International Regulatory Agency, OrbusMT, Spectranetics or as otherwise may be required pursuant to applicable laws, rules or regulations if 15 * * * This portion has been omitted pursuant to a request for confidential treatment and filed separately with the Commission.

Related to International Regulatory Agency

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • Public safety agency means a functional division of a public agency, county, or the state that provides fire fighting, law enforcement, ambulance, medical, or other emergency services.

  • international application means an application filed under this Treaty;

  • International Registry means the international registry established pursuant to the Cape Town Treaty.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Public or private safety agency means a unit of state or local government, a special purpose district, or a private firm, which provides or has the authority to provide firefighting, police, ambulance, emergency medical services or hazardous materials response.

  • International air transportation means transportation by air between a place in the United States and a place outside the United States or between two places both of which are outside the United States.

  • Health Agency means the California Department of Health Services, or the local health officer with respect to a small water system.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • Home health agency means a person certified by medicare whose business is to provide to individuals in their places of residence other than in a hospital, nursing home, or county medical care facility 1 or more of the following services: nursing services, therapeutic services, social work services, homemaker services, home health aide services, or other related services.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • international flight means all flights other than Domestic Flights.

  • International Student means a student holding a student visa for the purpose of obtaining an education in Australia and includes a student on a study abroad or international exchange program;

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • international air transport means air transport that passes through the airspace over the territory of more than one State;