DISTRIBUTOR Resources

To help our channel partners meet our compliance requirements, we are providing a number of reference documents, tools, and templates for their use. Some of these documents can be used as they are, while others may require modification and adjustments in order to be used properly, given that local laws, regulations, or trade association codes may include additional or different requirements. Finally, other documents may not be relevant to the business of every distributor. In cases where modifications are necessary, distributors may need to review these templates with their legal advisors before putting them to regular use.


General

Reference Tools and Examples Description - Definitions and examples of reference tools provided for distributor compliance program.

Distributor Compliance Presentation - Slides covered by the DRO during the on-site discussion about the Medtronic compliance and quality expectations.

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Compliance policy / code of conduct overview

Sample Code of Conduct - Distributors can use this template to design and formally adopt a code of conduct for their organization. Adjustments may be required to adapt to their business model, and to ensure alignment with local laws, regulations and trade association codes.

Business Partner Compliance Guidelines (Do’s and Dont's) - Contains detailed compliance guidelines and is used by Medtronic as part of its distributor compliance training program. It can also be used by distributors to conduct training of their own employees. Covers a variety of important compliance topics such as:

  • General principles
  • Conflicts of interest
  • Meals, gifts, grants and donations
  • Medical conferences, sponsorships and HCP compensation
  • Use of travel agents and event planners
  • Samples, free products
  • Clinical trials
  • Participation in tenders

Conflict of Interest Declaration - Template used to disclose actual or potential conflicts of interest to Medtronic in a timely and effective manner. It is also used to document the decision made on how the matter is to be resolved.

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Training

Distributor Employee Training Attendance Form - Used to establish documentation that the distributor provided compliance training to its employees.

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Use of sub-distributors

Notification on Use of Sub-Distributors - Letter to notify Medtronic about any and all sub-distributors used or to be used in the fulfillment of the distribution agreement. This document is also included in Annex A of the Medtronic distribution agreement.

Due Diligence Quick Check - Record to document the performance of due diligence on any sub-distributors used or to be used in the fulfillment of the distribution agreement.

Sample Code of Conduct - Distributors can use this template to design and formally adopt a code of conduct for their organization. Adjustments may be required to adapt to their business model, and to ensure alignment with local laws, regulations and trade association codes.

Business Partner Compliance Guidelines (Do’s and Dont's) - Contains detailed compliance guidelines and is used by Medtronic as part of its distributor compliance training program. It can also be used by distributors to conduct training of their own employees. Covers a variety of important compliance topics such as:

  • General principles
  • Conflicts of interest
  • Meals, gifts, grants and donations
  • Medical conferences, sponsorships and HCP compensation
  • Use of travel agents and event planners
  • Samples, free products
  • Clinical trials
  • Participation in tenders

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Record Keeping and Cooperation with Inspection

Expense Reimbursement Form - Template used to support and document any business travel, meetings and expenses related to interactions with customers or potential customers. The distributor must establish spending limits for business related expenditures, such as meals, refreshments, lodging, and occasional educational items.

Samples Request - Form that can be used to keep proper documentation and tracking of samples that have been provided to customers. A sample is a material or equipment issued free of charge to a customer for the purpose of evaluating its functionality, in compliance with the local laws and regulations.

Consulting Agreement Notification Letter to HCP’s Employer - Letter template used to inform and obtain employer agreement when hiring healthcare professionals as speakers or for consulting services, or when sponsoring them to an educational event or product training.

Business Partner Compliance Guidelines (Do’s and Dont's) - Contains detailed compliance guidelines and is used by Medtronic as part of its distributor compliance training program. It can also be used by distributors to conduct training of their own employees. Covers a variety of important compliance topics such as:

  • General principles
  • Conflicts of interest
  • Meals, gifts, grants and donations
  • Medical conferences, sponsorships and HCP compensation
  • Use of travel agents and event planners
  • Samples, free products
  • Clinical trials
  • Participation in tenders

Sponsorship Agreement - Template used to document the support of a third party congress in return for certain sponsorship rights (e.g. booth, advertising in the program and on name badges, acknowledgment of support) which give the distributor an opportunity to promote the Medtronic brand and products to the specialist audience.

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Regulatory and quality requirements

Quality Guidelines for Distributors - Presentation explaining quality and regulatory requirements as they apply to Medtronic distributors, including product complaints, product handling and field corrective actions. Detailed instructions on the use of the mPXR site for reporting product complaints.

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Conflicts of interest and other escalation requirements

Business Partner Compliance Guidelines (Do’s and Dont's) - Contains detailed compliance guidelines and is used by Medtronic as part of its distributor compliance training program. It can also be used by distributors to conduct training of their own employees. Covers a variety of important compliance topics such as:

  • General principles
  • Conflicts of interest
  • Meals, gifts, grants and donations
  • Medical conferences, sponsorships and HCP compensation
  • Use of travel agents and event planners
  • Samples, free products
  • Clinical trials
  • Participation in tenders

Conflict of Interest Declaration - Template used to disclose actual or potential conflicts of interest to Medtronic in a timely and effective manner. It is also used to document the decision made on how the matter is to be resolved.

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