Quality and Regulatory Requirements For Third Parties
Any supplier that supplies a complete software product (in one or more countries) that is integrated into a product of Canon Medical and/or is resold separately as part of (or along with) a Canon Medical product is referred to herein as a “Third Party Supplier” and must comply with the requirements set forth as follows:
- Changes to Software Product. Third Party Supplier shall notify Canon Medical, at least 90 days in advance, of any changes to the products being provided, licensed and/or acquired under the underlying agreement (the “Products”). For the avoidance of doubt, a change shall be defined as any change that would affect the form, fit and function requirements of the Products as set forth in the agreement between Canon Medical and Third Party Supplier.
- Specifications. Third Party Supplier shall provide Canon Medical with the most current copy of the specifications for the Products (the “Specifications”), and shall promptly provide updated Specifications as they are updated.
- Acceptance. Acceptance of the Products shall be deemed to occur on the date when, in the reasonable opinion of Canon Medical, the Products conform to all Specifications, and has continuously operated in compliance with the Specifications for thirty (30) days. Canon Medical will notify Third Party Supplier of any issues of non-conformance. Third Party Supplier shall have thirty (30) days to cure any non-conformances preventing Acceptance. Acceptance of Products does not constitute a waiver of claims. In the event Canon Medical does not accept a Product, Canon Medical has the right to terminate the Agreement and receive a refund of all amounts paid to Third Party Supplier.
- Reporting. Third Party Supplier and Canon Medical shall immediately, at least within 2 business days, report (email shall be deemed sufficient notice) to each other any malfunction in the software product or any inadequacy in the customer instructions for the software product, that Third Party Supplier 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 the applicable 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.
- Reporting to the regulatory authority. Third Party Supplier shall be solely responsible for reporting such malfunctions or incidents to the appropriate regulatory authority, except where the applicable directives and/or regulation for medical devices in the country where the software product is sold states otherwise. Notwithstanding the above, Canon Medical may report malfunctions or incident to the appropriate authority if Third Party Supplier, after receiving information from the Canon Medical, does not report within an appropriate time and legal counsel for Canon Medical advises Canon Medical to report the issues. However, Canon Medical must prior inform Third Party Supplier if Canon Medical intends to report malfunctions of incidents to the appropriate regulatory authority and give Third Party Supplier the opportunity to either make the report on its own or to support Canon Medical with the report.
- Recalls and field corrections. In the event of recalls or field corrections of the software product that is required by a regulatory authority and/or by the Third Party Supplier for safety or efficacy reasons, Canon Medical agrees to (a) immediately stop selling and delivering such software product to customers; (b) reject all unfilled orders pertaining to such software product; (c) fully cooperate with Third Party Supplier with the recall and/or field correction and its realization; and (d) document all activities and actions performed by Canon Medical I during such recall and/or field corrections at least until expiration of ten (10) years after the Third Party Supplier software product end of life.
Third Party Supplier agrees to: (a) notify Canon Medical within 1 day of initiation a recall for a software product Canon Medical distributes; (b) provide sufficient information for Canon Medical to be able to assist with support calls related to recalls, including, but not limited to, technical information, clinical information, or any other things that may assist Canon Medical support in fielding questions; and (c) provide recall/FSN letter to Canon Medical in all languages representing the countries where the Product is distributed
- Documentation. Third Party Supplier shall request any special documentation that is required as part of the agreement between Canon Medical and Third Party Supplier. Canon Medical shall maintain records of, work in connection with the sales and services provided by Canon Medical for the software product hereunder in sufficient detail to comply with applicable regulatory and quality requirements (including without limitation, records relating to the following: customer, installation of software product at the customer site, acceptance of software product at customer site, acceptance of software product by customer, support services provided by the Canon Medical, customer complaints and complaint handling).
- Quality System. Third Party Supplier shall maintain an effective quality system for the development of the medical software product. Further, in connection with the release of each version of software product provided to Canon Medical, Third Party Supplier shall provide the following information:
- ISO Certification/MDSAP Certification;
- CE Mark Certificate;
- Declaration of Conformity;
- EU Essential Requirements, Australian Essential Principles checklist;
- Quality Manual
- Risk Analysis*;
- Unresolved Anomalies List*;
- Release Notes*;
- Verification and Validation Test Results*
- MDR’s GSPR checklist*.
*: preferred but not mandatory
- Regulatory Clearances. As available as changes occur, Third Party Supplier shall provide Canon Medical with the following information, to support its distribution of the software product:
- List of countries with market clearances or registrations, including product registration identification number and date of registration, at least for MDSAP countries (US, Australia, Brazil, Canada and Japan);
- 3rd Party Approval Form QSP-102.F002;
- US FDA 510(k) product clearance information;
- current product labeling, including UDI (Unique Device Identifier) information per FDA CFR Part 830, included with 510(k) submission; and
- the applicable product labeling translations.
For all countries for which Third Party Supplier has not obtained regulatory clearance and Canon Medical requests that the Third Party Supplier obtain regulatory clearance, the Third Party Supplier agree to consider obtaining regulatory clearance or allowing Canon Medical to obtain regulatory clearance for the Third Party Supplier, in order to allow Canon Medical to market, sell and distribute the software product. This decision shall be at the sole discretion of the Third Party Supplier and depends in general on the market potential. Any malfunction or incident in any of these countries that requires reporting to the regulatory authorities, including those requiring a recall or field correction, shall be handled as in the previous paragraphs.
- Audit Rights. Either Canon Medical or a regulatory body has the right to audit the Third Party Supplier’s compliance with the applicable standards (including but not limited to ISO 13485 and MDSAP country requirements) with reasonable notice. The cost of such audit shall be covered by Canon Medical.