Coloplast Corp. California Declaration of Compliance

Consistent with HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers, we have tailored our Comprehensive Compliance Program to the nature of our business as a medical device manufacturer. The medical device industry has established, and Coloplast’s Comprehensive Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, which reflects the unique interactions between medical device companies and health care professionals.

Government standards on compliance programs recognize that no program can completely prevent individual employees from improper conduct. Recognizing that compliance is a dynamic concept, Coloplast continuously reviews and updates its Comprehensive Compliance Program to improve it.  As a result, the Comprehensive Compliance Program periodically incorporates changes in policy and approach that require the subsequent development of new and upgraded systems.

Coloplast has developed a Comprehensive Compliance Program that we believe meets the compliance goals set forth by the California Health and Safety Code Chapter 8, §§ 119400-119402. To the best of our knowledge, we are in compliance with our Comprehensive Compliance Program in all material respects.

You can also obtained a copy of this document by calling Coloplast at 1-800-788-0293.

Last updated: August 23, 2018