California Declaration of Compliance

Ambu has established and maintains a Business Ethics and Compliance Program in accordance with the Compliance Program Guidance issued by the Office of Inspector General (OIG), U.S. Department of Health and Human Services. Our Business Ethics and Compliance Program is just one attribute that demonstrates our commitment to high standards of corporate conduct and ethical practices and is tailored to Ambu’s size, organizational structure, and resources to reasonably meet the specific needs of Ambu. Our compliance policies and procedures are built upon the various laws, regulations, industry code (the Advanced Medical Technology Association or AdvaMed Code of Ethics on Interactions with Healthcare Professionals) and other requirements relevant to Ambu’s business. The AdvaMed Code was developed to provide guidance specifically to the medical device industry. The AdvaMed Code is the medical device industry’s equivalent to the voluntary Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (PhRMA Code), which was developed to provide guidance to the pharmaceutical industry.

As a part of Ambu’s Business Ethics and Compliance Program, an annual aggregate dollar limit has been established concerning appropriate items covered by the California Health and Safety Code, §§ 119400-119402, that are provided to Healthcare Professionals. Examples of these items include a modest meal provided while discussing Ambu products, indications, or efficacy; or items or activities permitted under the OIG’s Compliance Program Guidance and AdvaMed Code. 

Based upon Ambu’s good faith understanding of the California Health and Safety Code, Ambu excludes certain items and payments from its annual dollar limit, which are listed below.

• Financial support for continuing medical education forums, including independent education
• Financial support for health educational scholarships
• Payments for legitimate professional services, and any meals or expenses associated with the provision of such services, that are based on the fair market value of the services provided
• Educational items that are provided to physicians to give to their patients to assist and enhance the patient’s understanding or management of their condition

Annual Declaration for Purposes of California Health and Safety Code §§ 119400-19402

Ambu maintains a comprehensive Business Ethics and Compliance Program and declares, to the best of its knowledge and based upon a good faith understanding of the applicable statutory requirements, that the indicated program encompasses the compliance requirements in all material respects stated in the California Health and Safety Code. Ambu further affirms that the program is designed to detect, prevent, and address misconduct appropriately.

As of the date of this declaration, Ambu declares that, to the best of its knowledge, it is in fundamental compliance with the Business Ethics and Compliance Program described above as it relates to the marketing and promotion of our products and the California Health and Safety Code, §§ 119400-119402. Ambu will continue to assess the Business Ethics and Compliance Program and the overall effectiveness of the program at least annually.

To obtain a print version of this document or Ambu’s Business Ethics and Compliance Program, please contact 1-800-262-8462.

Last updated: June 2024