Customer Support

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Quality and Regulatory Requirements for Importers, Distributors and Resellers

  1. Reporting. Importer/Distributor/Reseller and Canon Medical (“Canon Medical”) shall immediately, at least within 2 business days, report (email shall be deemed sufficient here) to each other any malfunction in the software product or any inadequacy in the customer instructions for the software product, Importer/Distributor/Reseller and Canon Medical become aware of, which results in potential or real medical hazard for the customer or the patients and that is notifiable under the US FDA regulations, Australia regulations, Brazil regulations, Canada regulations, Japan regulations, EU Medical Device Regulations, and the regulations and directive in force in the territory where the software product is installed.
  2. Device Labeling. The Importer/Distributor/Reseller shall not modify or alter the delivered product. Distributor/Reseller shall provide Canon Medical with such technical and marketing information as Canon Medical may from time to time reasonably request. Distributor/Reseller shall not market the software product except in conformance with Canon Medical’s policies and device labeling, including a prohibition on making any representations regarding the products that would be considered “off-label” under applicable laws and regulations
  3. Audit Rights. Either Canon Medical or a regulatory body at all reasonable times and on reasonable notice, has the right to audit and inspect all records and procedures of the Importer/Distributor/Reseller which relate to the provision of services to Canon Medical (including but not limited to applicable standards, such as ISO 13485 and MDSAP country requirements), to verify the compliance with the agreement between Canon Medical and Importer/Distributor/Reseller. The cost of such audit shall be covered by Canon Medical.
  4. Distribution Traceability Records. Importer/Distributor/Reseller shall comply with all applicable laws and regulations relating to the marketing, sale, distributions and traceability records of Canon Medical’s products. For a period of not less than ten (10) years, Importer/Distributor/Reseller shall maintain full and complete quality records and records of product distribution, including customer name, location and version. Importer/Distributor/Reseller shall also provide Licensor with such End-User information as it may reasonably request. Importer/Distributor/Reseller shall make its records related to this Agreement available for inspection upon request by applicable governmental authorities.
  5. Complaints. Importer/Distributor/Reseller shall provide Canon Medical with information regarding any complaints or notifications about incidents related to Canon Medical’s software product, in a format recommended by Canon Medical or any other format agreeable to Canon Medical within five (5) business days of Importer/Distributor/Reseller’s receipt of such complaint.
  6. Post Market Surveillance. Importer/Distributor/Reseller shall provide assistance with vigilance and post market surveillance, in cooperation with Canon Medical , according to applicable medical device regulations.
  7. Adverse Events Reporting and Recall. If Canon Medical believes that a corrective action with respect to any product is desirable or required by law, or if the FDA or any other any governmental agency having jurisdiction shall request or order any corrective action with respect to such product, including any recall, customer notice, restriction, change, corrective action, market action or product correction, Canon Medical shall promptly notify Importer/Distributor/Reseller. Importer/Distributor/Reseller shall provide assistance with recalls, adverse events reporting and execution of recalls in cooperation with Canon Medical, according to applicable medical device regulations.

Additional Requirements for Importers/Distributors/Resellers located in the European Union:

To comply with European Union Medical Device Regulation of 2017 (the “Regulation”):

  1. Importer/Distributor/Reseller shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date. The quality management system shall cover, inter alia, procedures ensuring that the distributor/reseller or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
  2. Importer/Distributor/Reseller shall co-operate with manufacturers or authorized representatives to achieve an appropriate level of traceability of devices.
  3. Importer/Distributor/Reseller/ shall be able to identify the following to the competent authority, for the period of at least 10 years after the last software product covered by the EU declaration of conformity has been placed on the market:
    1. any economic operator to whom they have directly supplied a device;
    2. any economic operator who has directly supplied them with a device;
    3. any health institution or healthcare professional to which they have directly supplied a device.
  1. Importer/Distributor/Reseller shall cooperate with the competent authorities regarding any compliance activities.
  2. Importer/Distributor/Reseller shall without delay ensure that all appropriate corrective action is taken throughout the European Union in respect of all the software products concerned that they have made available on the market.
  3. Importer/Distributor/Reseller shall cooperate with the competent authority to bring any regulatory non-compliance to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance.

The following only applies to Importer:

  1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
  2. In order to place a device on the market, importers shall verify that:
    (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
    (b) a manufacturer is identified and that an authorized representative in accordance with Article 11 has been designated by the manufacturer;
    (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
    (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
  3. Importers who consider or have reason to believe that a software product which they have placed on the market is not in conformity with the Regulation shall immediately inform the manufacturer and its authorized representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorized representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the EU Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 of the Regulation for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
  4. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorized representative. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorized representative and distributors/resellers with any information requested by them, in order to allow them to investigate complaints.

The following only applies to Distributor/Reseller:

  1. Before making a device available on the market, distributors/resellers shall verify that all of the following requirements are met:
    (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
    (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
    (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
    (d) that, where applicable, a UDI has been assigned by the manufacturer.
    In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor/reseller.
  2. Where a Distributor/Reseller considers or has reason to believe that a software product is not in conformity with the requirements of the Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorized representative, and the importer. Where the Distributor/Reseller considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
  3. Distributors/Resellers that consider or have reason to believe that a device which they have made available on the market is not in conformity with the Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. Distributors/Resellers shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorized representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the Distributor/Reseller considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
  4. Distributors/Resellers that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorized representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorized representative and the importer informed of such monitoring and provide them with any information upon their request.