Medical Device Regulation. If any of the Products are medical devices, Buyer acknowledges that it is familiar with SOR /98-282 Medical Devices Regulations and the reporting obligations imposed on device users thereunder. In this regard, Xxxxx agrees to notify ZEISS within ten (10) days of the occurrence of any event identified in the Regulations imposing a reporting obligation on Buyer and/or ZEISS, except for critical incident events representing an imminent hazard that require notification to Health Canada within ten days, in which case, such notice will be delivered to ZEISS immediately. Buyer shall maintain adequate tracking for the Products to enable ZEISS to meet the Health Canada requirements applicable to the tracking of medical devices.
Medical Device Regulation. (a) Company has obtained all applicable licenses, registrations, approvals, clearances, and authorizations required for Company's business by any governmental entity regulating the safety, effectiveness and market clearance of Company's medical components or devices that are currently marketed by Company in the territories in which such components or devices are currently marketed. Such licenses, registrations, approvals, clearances, and authorizations have not been withdrawn, revoked or challenged and Company has not taken any action with respect to the design, development, manufacture or distribution of any such medical component or device which could reasonably be expected to lead to such withdrawal, revocation or challenge. Set forth on Schedule 3.18 is information related to the regulation of Company's medical devices that are currently marketed or that have been approved for marketing since January 1, 1997, including any recalls, product actions and inspections of Company's Facilities.
(b) Since January 1, 1997 Company recorded no "complaints" (as such term is defined in 21 C.F.R. Section 820.198) and reported no Medical Device Reports ("MDRs"). Set forth on Schedule 3.18 are certain customer comments with respect to Company's products.
(c) Company manufactures and for the past five years has manufactured its products in accordance with all applicable FDA rules and regulations (including the Good Manufacturing Practices and the Quality System regulations promulgated by the FDA) and the European Medical Device Directive (93142/ECC) and quality control procedures of Company in effect at the time of manufacture. To the extent required, all of the products currently sold by Company have been approved for sale by the FDA and all other applicable federal, state, local and foreign regulatory agencies. None of Company's products are permitted to be marked with the "CE" xxxx. Company has not received any notice from the FDA or any other federal, state, local or foreign regulatory agency calling into question its manufacturing practices or threatening to revoke or curtail any product approval, and Company and the Shareholders are not aware of any intent to deliver any such notice. Schedule 3.18 contains a complete list of all products manufactured or marketed by Company, including those that require the approval of or notice to, or registration with, the FDA or any other United States federal or state or foreign governmental entity under any existing law, regu...
Medical Device Regulation. As to each product subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) or to the jurisdiction of the EMA, AMAR or any other regulatory agency or body of any other country performing similar functions (a “Foreign Device Regulator”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its subsidiaries (each such product, a “Regulated Product”), such Regulated Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its subsidiaries, and none of the Company or any of its subsidiaries has received any notice, warning letter or other communication from the FDA or any Foreign Device Regulator, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Regulated Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Regulated Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its subsidiaries, (iv) enjoins production at any facility of the Company or any of its subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its subsidiaries, and which, either individually or in the aggregate, would not have or reasonably be expected to result in a Mate...
Medical Device Regulation. In the event Customer uses the SDK to build mobile applications, Customer is solely responsible for complying with all regulatory laws and rules applying to such mobile applications, including but not limited to the laws on medical devices and licensing and professional practice requirements. If Customer is subject to EU laws, Customer will not use the SDK to develop medical devices of class 2 and above as defined in Medical Device Directive 93/42/EEC.
Medical Device Regulation. Companies informs Distributor that Sections 1, 2, and 3 are requirements of the Medical Device Directive (93/42/EEC), and that non respect by Distributor of these sections will oblige Companies to immediately cease supply of Products to Distributor, and will be regarded as failure to perform a material obligation, warranty, duty or responsibility.
Medical Device Regulation. Except as set forth in Schedule 3.17, Seller has obtained all applicable licenses, registrations, approvals, clearances, and authorizations required by Governmental Authorities regulating the safety, effectiveness and market clearance of Seller's medical devices which are currently marketed by Seller in respect of the territories in which such devices are currently marketed. Such licenses, registrations, approvals, clearances, and authorizations have not been withdrawn, revoked or challenged and to Seller's Knowledge, Seller has not taken any action with respect to the design, development, manufacture or distribution of any such medical device which could reasonably be expected to lead to such withdrawal, revocation or challenge. Set forth in Schedule 3.17 is information relating to the regulation of Seller's medical devices that are currently marketed or that have been approved for marketing
