Effective January 1, 2018, to the best of our knowledge and to our good faith understanding of the statutory provisions that may apply to a medical device manufacture operating in California, NIDEK, INC. is in all material respects in compliance with the California Comprehensive Compliance Program (“CCP”), as well as being in compliance with the requirements under of California Health & Safety Code §§ 119400-119402.
NIDEK, INC. has created its CCP on The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”), which applies to the medical device industry and is similar to the PhRMA Code, in which is consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (“HHS-OIG Guidance”).
In accordance to California Health & Safety Code §§ 119400-119402, NIDEK, INC. has established an annual spending limit of $2,500 per year for specific promotional activities directed toward “individual medical and healthcare professionals” practicing in California. The annual spending limit applies to gifts, promotional materials, and other items or activities that are provided to California individual medical and healthcare professionals, but does not include work related remuneration.
NIDEK, INC. is committed to the highest standards of ethical and legal conduct. We have developed a CCP that is realistically designed to prevent and identify violations, and includes the following:
Written Standards. We have established a Corporate Conduct Charter, in which is a Global Policy, as well as a Compliance Policy.
Compliance Officer and Compliance Committee. We have established and have designated a Compliance Officer and a Compliance Committee for operational oversight of the CCP.
Training and Education. NIDEK, INC. understands the importance of continued training and education for an effective compliance program. And therefore, we are committed to ensuring that all employees, especially those who interact with Healthcare Professionals regularly, fully understand, are aware, and agree to comply with NIDEK, INC.’s written standards in our Corporate Conduct Charter and Compliance Policy. Ongoing education and training is provided to our employees on a regular basis.
Reporting and Lines of Communication. Confidentiality and Non-Retaliation policies have been implemented, including the ability for anonymous reporting. It is the responsibility of the Compliance Officer to maintain any/all lines of confidential communication being reported.
Monitoring and Periodic Review. The Compliance Office and the Compliance Committee are responsible for the continued monitoring and periodic reviews of compliance with NIDEK, INC.’s CCP. This also includes the responsibility of implementing and administrating the CCP throughout the organization,
including the activities of sales and marketing personnel. We will take the necessary steps to ensure that violations do not reoccur.
6. Corrective Action. The CCP has been designed to prevent and identify any/all conduct that may inconsistent and/or not in compliance with any/all applicable laws or regulations or the HCP guidelines. Any/all improper conduct that is identified, NIDEK, INC. will address it promptly and responsibly with corrective action including, but not limited to, appropriate disciplinary action. The necessary corrective action(s) will be applied to prevent recurring violations
COPIES OF OUR COMPREHENSIVE COMPLIANCE PROGRAM AND ANNUAL DECLARATION OF COMPLIANCE CAN BE OBTAINED BY CALLING OUR TOLL FREE NUMBER AT (833) 796-2624 OR YOU CAN VISIT OUR WEBSITE AT USA.NIDEK.COM