Distributor compliance
Distributor resources
Find reference documents, tools, and templates for meeting distributor compliance requirements.
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.
Medtronic has also partnered with AdvaMed and other member companies to create a comprehensive Global Distributor Compliance Toolkit (“GDC Toolkit”) for use by all organizations in the global medical technology supply chain. The GDC Toolkit’s 50+ compliance assets include training slides, compliance forms, communication templates, infographics and more, spread across the six Key Areas of Global Compliance. It is highly customizable and neutrally branded, so it can be easily adapted by any distributor. Click on the AdvaMed logo to access the GDC Toolkit.
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.
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. This document is not intended for the distributor to simply replace its own name and use as is.
Business partner compliance guidelines (do’s and don’ts) - 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.
Distributor employee training attendance form - Used to establish documentation that the distributor provided compliance training to its employees.
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 don’ts) - 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
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 don’ts) - 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.
Grant or donation packet - Use this packet when agreeing to fulfill a grant or donation request. Templates included: 1. Grant/Donation Request - To request approval internally to provide a grant or donation. 2. Grant/Donation Agreement - To document your donation or grant agreement with the recipient of the funds.
HCP meeting, event, or training packet - Use this packet when inviting an HCP to attend a meeting, event or training. Templates included: 1. Internal Approval - To seek approval within your company. 2. HCP Invitation - To extend an invitation to an HCP. 3. Employer Notification - To notify the HCP’s Employer (this may not be a requirement depending on the local laws, regulation or applicable industry associations codes).
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.
Business partner compliance guidelines (do’s and don’ts) - 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.