MEMBER CERTIFICATION FAQS 2024-2026
Q: What does the Certification require?
A: The Certification requires companies to self-certify that they have adopted policies at least as stringent as or policies consistent with the AdvaMed Code of Ethics and implemented the seven elements of an effective compliance program. These elements align with the U.S. Department of Justice Evaluation of Corporate Compliance Programs and HHS Office of the Inspector General Compliance Program Effectiveness Guidance and outline specific programs and processes companies must maintain to ensure effective compliance with the Code.
Q: Are AdvaMed Members required to certify adoption?
A: No. The certification is strictly voluntary. However, AdvaMed strongly encourages all medical technology manufacturers to adopt effective compliance programs consistent with the AdvaMed Code of Ethics.
Q: Who must execute the Certification?
A: The Chief Executive Officer (CEO) and Chief Compliance Officer (CCO) (or their equivalents) of the legal entity seeking to certify must sign and date the Certification of Adoption. For non-U.S. companies, the Certification may be signed by the highest-ranking U.S. corporate executives having authority over the company’s U.S. operations. The CEO may wish to consult with legal counsel regarding the implications of certification prior to signing the Certification.
Q: How often must my company complete the Certification?
A: The Certification must be renewed biennially.
Q: If my company acquires a new business unit that has not adopted the AdvaMed Code, is my certification still valid?
A: Certifying companies should make every effort to adopt the AdvaMed Code and implement an effective compliance program with regard to a newly acquired business unit as quickly as possible. The certification is made as of the date it is signed and applicable to the company as it existed at that time; a later acquisition would not violate its terms. However, a company should not renew its annual certification the following year if it has not adopted the AdvaMed Code across all of its business units for which the AdvaMed Code is relevant. The only circumstance in which a company may certify adoption of the AdvaMed Code by a smaller subset of its business units is when an acquisition may have closed too recently before the date of annual certification for the acquiring company to have completed its compliance evaluation and made any necessary adjustments to bring the newly acquired business unit into compliance with the Code. In such cases, the acquiring company may renew its certification for its other businesses but must include a notification that the certification does not apply to the newly acquired business unit. Unless the company provides a date at which the new unit will be in compliance and covered by the certification, the company will be expected to include the new unit in the following year’s certification.
Q: Is there a standard set of attributes that constitute an effective compliance program?
A: A company’s compliance program should be appropriately tailored, meaning it will take into account the company’s size, resources, lines of business, and workforce. Many companies’ compliance policies and procedures will be tailored to address the specific types of risks that apply to their operations. This could result in some companies’ policies and procedures differing from others’, while still adhering to an effective compliance program.
Q: How does my company’s certification of adoption of the AdvaMed Code relate to the Code of Ethics Logo?
A: If your company certifies adoption of the Code, you have the additional option of displaying the Code of Ethics Logo—a symbol of that certification and commitment to compliance. The logo is available to member companies as an AdvaMed member benefit, once they have completed the certification process. The logo is available to non-member companies for an annual royalty fee of $2000. The logo may be used on business cards, trade show booths, brochures and in certain other means to visible demonstrate your company’s commitment to the AdvaMed Code.
Q: What if my company manufactures pharmaceuticals or biologics in addition to medical technologies covered by the AdvaMed Code?
A: A company may obtain a certification for its medical technology component, division or affiliate, rather than for the company as a whole, and the certification would apply to the business units and employees whose activities make the AdvaMed Code relevant. Any Logo materials used by the company should make this distinction clear.
Q: How do I access AdvaMed-approved training materials?
A: Training materials approved by AdvaMed are accessible via the AdvaMed web site.