Applicable Medical Device Regulation Sample Clauses

Applicable Medical Device Regulation. The Interim Regulation for Medical Devices, issued by the Saudi Food and Drug Authority Board of Directors’ Decree number 1-8-1429 dated 27 December 2008, published on 17 April 2009 in Umm AL-QURA Journal year 86 issue No 4249 and its relevant Implementing Rules.
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Applicable Medical Device Regulation. The Medical Devices Law issued by Royal Decree No. (M/54) dated 18 February 2021, and Implementing Regulation of Medical Devices Law issued by the Saudi Food and Drug Authority Board of Directors’ Decree No. (3-29-1443) dated 19/2/1443H.

Related to Applicable Medical Device Regulation

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • MEDICAL DEVICES This Article applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC. Medical Device as used herein will have the meaning provided by the U.S. Food and Drug Administration (“FDA”) and means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (i) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (ii) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (iii) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Supplier warrants that prior to UC’s purchase or lease of any Medical Device or Supplier’s use of any Medical Device in providing Goods and/or Services hereunder, Supplier will: (i) perform security testing and validation for each such Goods and/or Services or Medical Device, as applicable; (ii) perform a security scan by an anti-virus scanner, with up-to-date signatures, on any software embedded within any Goods and/or Services or Medical Device, as applicable, in order to verify that the software does not contain any known viruses or malware; (iii) conduct a vulnerability scan encompassing all ports and fuzz testing; and (iv) provide UC with reports for (i) – (iii). Supplier warrants that all security testing performed by Supplier covers all issues noted in the “SANS WE TOP 25” and/or “OWASP Top 10” documentation. Throughout Supplier’s performance of this Agreement, Supplier will provide UC with reasonably up-to-date patches, firmware and security updates for any Medical Device provided to UC, and any other Medical Device used in the course of providing Services, as applicable. All such patches and other security updates will be made available to UC within thirty (30) days of its commercial release or as otherwise recommended by Supplier or Supplier’s sub-supplier, whichever is earlier. Supplier warrants that all software and installation media not specifically required for any Medical Device used by Supplier or Goods and/or Services delivered to UC under this Agreement as well as files, scripts, messaging services and data will be removed from all such Goods and/or Services or Medical Device following installation, and that all hardware ports and drives not required for use or operation of such Goods and/or Services or Medical Device will be disabled at time of installation. In addition, Medical Devices must be configured so that only Supplier-approved applications will run on such Medical Devices. Supplier agrees that UC may take any and all actions that it, in its sole discretion, deems necessary to address, mitigate and/or rectify any real or potential security threat, and that no such action, to the extent such action does not compromise device certification, will impact, limit, reduce or negate Supplier’s warranties or any of Supplier’s other obligations hereunder. Supplier warrants that any Medical Device provided to UC, and any other Medical Device used in the course of providing such Goods and/or Services, meet and comply with all cyber-security guidance and similar standards promulgated by the FDA and any other applicable regulatory body. If the Goods and/or Services entail provision or use of a Medical Device, Supplier will provide UC with a completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) form for each such Medical Device before UC is obligated to purchase or lease such Medical Device or prior to Supplier’s use of such device in its performance of Services. If Supplier provides an MDS2 form to UC concurrently with its provision of Goods and/or Services, UC will have a reasonable period of time to review such MDS2 form, and if the MDS2 form is unacceptable to UC, then UC in its sole discretion may return the Goods or terminate the Agreement with no further obligation to Supplier.

  • Information Technology Accessibility Standards Any information technology related products or services purchased, used or maintained through this Grant must be compatible with the principles and goals contained in the Electronic and Information Technology Accessibility Standards adopted by the Architectural and Transportation Barriers Compliance Board under Section 508 of the federal Rehabilitation Act of 1973 (29 U.S.C. §794d), as amended. The federal Electronic and Information Technology Accessibility Standards can be found at: xxxx://xxx.xxxxxx-xxxxx.xxx/508.htm.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Fire, Life Safety, and Accessibility Codes The following codes, in the versions approved by the Georgia State Fire Marshal/Fire Safety Commissioner and Department of Human Resources, shall be used. The Design Professional will designate any additional codes or special modifications in the Supplementary General Conditions.

  • Designated Prescription Drug Prescribers and Pharmacies We may limit your selection of a pharmacy to a single pharmacy location and/or a single prescribing provider or practice. Those members subject to this designation include, but are not limited to, members that have a history of: • being prescribed prescription drugs by multiple providers; • having prescriptions drugs filled at multiple pharmacies; • being prescribed certain long acting opioids and other controlled substances, either in combination or separately, that suggests a need for monitoring due to: o quantities dispensed; o daily dosage range; or o the duration of therapy exceeds reasonable and established thresholds. The Amount You Pay for Prescription Drugs Our formulary includes a tiered copayment structure, which means the amount you pay for a prescription drug will vary by tier. See the Summary of Pharmacy Benefits for your copayment structure, benefit limits and the amount you pay. When you buy covered prescription drugs and diabetic equipment and supplies from a retail network pharmacy, you will be responsible for the copayment and deductible (if any) at the time of purchase. You will be responsible for paying the lower of your copayment, the retail cost of the drug, or the pharmacy allowance. Specialty prescription drugs are generally obtained from a specialty pharmacy. If you buy a specialty prescription drug from a retail network pharmacy, you will be responsible for a significantly higher out of pocket expense than if you bought the specialty drug from a specialty pharmacy. The amount you pay for the following prescription drugs is not subject to the tiered copayment structure: • Contraceptive methods; • Over-the-counter (OTC) preventive drugs; • Nicotine replacement therapy (NRT) and smoking cessation prescription drugs; • Infertility specialty prescription drugs; and • Covered diabetic equipment or supplies bought at a network pharmacy. See the Summary of Pharmacy Benefits for benefit limits and the amount you pay. This plan allows for medication synchronization in accordance with R.I. General Law

  • Technical Regulations 1. The rights and obligations of the Parties in respect of technical regulations, standards and conformity assessment shall be governed by the WTO Agreement on Technical Barriers to Trade.

  • CHILD AND DEPENDENT ADULT/ELDER ABUSE REPORTING CONTRACTOR shall establish a procedure acceptable to ADMINISTRATOR to ensure that all employees, agents, subcontractors, and all other individuals performing services under this Agreement report child abuse or neglect to one of the agencies specified in Penal Code Section 11165.9 and dependent adult or elder abuse as defined in Section 15610.07 of the WIC to one of the agencies specified in WIC Section 15630. CONTRACTOR shall require such employees, agents, subcontractors, and all other individuals performing services under this Agreement to sign a statement acknowledging the child abuse reporting requirements set forth in Sections 11166 and 11166.05 of the Penal Code and the dependent adult and elder abuse reporting requirements, as set forth in Section 15630 of the WIC, and shall comply with the provisions of these code sections, as they now exist or as they may hereafter be amended.

  • Primary Care Clinic Employees and each of their covered dependents must individually elect a primary care clinic within the network of providers offered by the plan administrator chosen by the employee. Employees and their dependents may elect to change clinics within their clinic’s Benefit Level as often as the plan administrator permits and as outlined above.

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