Pursuant to the AdvaMed India Code of Ethics on Interactions with Health Care Professionals (“AdvaMed India Code”), medical technology companies, both AdvaMed members and non-members, may certify that they have agreed to abide by the AdvaMed India Code, and further that they have implemented policies and procedures to implement the AdvaMed India Code as part of an effective compliance program. This certification form is for companies that are AdvaMed Members. This certification requires a company’s Chief Executive Officer (CEO) and Chief Compliance Officer (CCO), or other senior individuals with equivalent responsibilities, to sign and affirm that their company has taken the steps identified below. AdvaMed will list the certifying company on the AdvaMed website in 2024-2026 as a company that submitted this certification. (see www.advamed.org/IndiaCodeCertifyingCompanies) AdvaMed retains the right to remove a company from that list, at its sole discretion, for a Company’s failure to abide by the terms of the AdvaMed India Code Certification.

On behalf of

(identify Company name or relevant portions/subsidiaries) (“Company”), I certify that, to the best of my knowledge and as of the date of this certification:

I have read and am familiar with the provisions of the AdvaMed Code of Ethics on Interactions with Health Care Professionals in India (“AdvaMed India Code”).

I am knowledgeable about our Company’s compliance and ethics program (“Compliance Program”) as it relates to the AdvaMed India Code.

Our Company requires all officers, employees, and agents to abide by the AdvaMed India Code for all interactions involving Health Care Professionals in India as that term is defined in the AdvaMed India Code.

Our Company has communicated the provisions of the AdvaMed India Code to our dealers and distributors with the expectation that they will adhere to them.

Our Company has made a copy of the AdvaMed India Code and/or a link to the AdvaMed India Code available on our Company’s public Web site.

Our Company agrees to respond to requests for information made to the compliance contact identified below.

Our Company adopted the AdvaMed India Code and implemented an appropriately tailored effective compliance program related to our interactions with Health Care Professionals in India by taking the following steps:

• Written Policies and Procedures: Established and implemented policies and procedures that incorporate and foster compliance with the provisions of the AdvaMed India Code.
• Compliance Officer/Committee: Established appropriate oversight and management of the Compliance Program, including: (a) identifying a senior manager in our Company who is responsible for compliance with our Company’s policies and procedures consistent with the AdvaMed India Code; and (b) creating a compliance committee or other equivalent process comprised of senior leadership who are actively engaged in the oversight of our Compliance program.
• Training and Education: Provided effective training to those employees and contractors whose job requirements make the information relevant on Company policies that are based on the AdvaMed India Code and implemented procedures to ensure ongoing training programs for such new employees and contractors.
• Lines of Communication: Established effective lines of communication, including a resource for employees to ask questions as well as an anonymous reporting hotline to facilitate internal reporting of suspected violations of Company policies that are based on the AdvaMed India Code, and publicized this hotline, or contact information for our compliance department, on AdvaMed’s website.
• Auditing and Monitoring: Instituted processes within our Company to conduct internal risk assessments, monitoring and auditing of the Company policies and procedures that are based on the AdvaMed India Code and to assess the overall effectiveness of our Company’s Compliance Program.
• Enforcement: Established a disciplinary process for violations of those policies and procedures that support the AdvaMed India Code.
• Corrective Action: Established a process to promptly respond to detected problems or violations of Company policies that are based on the AdvaMed India Code.

INDIA COMPLIANCE CONTACT INFORMATION FOR ADVAMED WEBSITE (REQUIRED):

This contact information will be posted to: www.advamed.org/IndiaComplianceContacts

Non-Member Certification FAQs

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 India Code and implemented the seven elements of an effective compliance program.

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-India companies, the Certification may be signed by the highest-ranking India corporate executives having authority over the company’s India 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 (every two years).

Q: If my company acquires a new business unit that has not adopted the AdvaMed India Code, is my certification still valid?

A: Certifying companies should make every effort to adopt the AdvaMed India 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 biennial certification the following year if it has not adopted the AdvaMed India Code across all of its business units for which the AdvaMed India Code is relevant.

The only circumstance in which a company may certify adoption of the AdvaMed India Code by a smaller subset of its business units is when an acquisition may have closed too recently before the date of biennial 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 AdvaMed India 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 India Code relate to the AdvaMed India Code Certified Logo?

A: If your company certifies adoption of the AdvaMed India Code, you have the additional option of licensing the AdvaMed India Code Certified 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 $300 once they have completed the certification process The logo may be used on business cards, trade show booths, brochures and in certain other means to visibly demonstrate the company’s commitment to the AdvaMed India Code. Companies are strongly encouraged to take this additional step.

Q: What if my company manufactures pharmaceuticals or biologics in addition to medical technologies covered by the AdvaMed India 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 India Code relevant. Any Logo materials used by the company should make this distinction clear.

ADVAMED INDIA CODE CERTIFIED LOGO LICENSE AGREEMENT FOR NON-MEMBERS 2024-2026

AdvaMed developed a distinctive India Code Certified Logo (“Logo”) for medical technology manufacturers that have executed the Certification of Adoption of the AdvaMed India Code (“AdvaMed India Code Certification”) and wish to use the Logo. The Logo is intended to provide a visible symbol of a certifying medical technology company’s commitment to the ethical standards embodied by the AdvaMed India Code and to promote awareness about the AdvaMed India Code among industry, health care professionals, and the general public.

This license agreement is for AdvaMed non-member companies. Non-member companies seeking to use the Logo must sign the following nonexclusive license provision and pay an annual royalty fee of $300. AdvaMed retains the right to revoke this License for a Company’s failure to abide by the terms of the AdvaMed India Certification.

Revocation of License to Display Logo:

      1.  In the event that AdvaMed, in its sole discretion, determines that a licensee has failed to comply with the terms of this licensing agreement, AdvaMed shall notify the licensee of its determination.  If, in the opinion of AdvaMed, the licensee fails to establish compliance with this agreement within 30 days of such notice, AdvaMed shall notify the licensee in writing that the license is revoked.  The licensee shall, within ten days of such notice of revocation, cease displaying the licensed logo. 

      2.  In the event that a licensee shall continue to display the logo in violation of Paragraph 1 of this Section, AdvaMed may seek relief in any court of competent jurisdiction.  If such court orders any relief sought by AdvaMed, or if the licensee subsequent to the initiation of litigation ceases its use of the logo, the licensee shall reimburse AdvaMed for all litigation costs, including attorneys’ fees.

 On behalf of 

(identify company name or name of relevant portions/subsidiaries), I agree to abide by the following terms  to receive a revocable, non-transferable, nonassignable, non-exclusive license to use an unaltered version of the Logo on marketing materials, business cards, and displays at meetings and conferences, and stationery:

• The Logo may not be used on any product;
• The licensee acknowledges and agrees that the right to use the Logo, as well as the actual use of the Logo, is not an endorsement by AdvaMed; and
• The right to use the Logo is subject to the licensee’s biennial completion of the AdvaMed India Code Certification.

AdvaMed India Code Certified Logo License Agreement for Non-Members FAQ

Q: What is the purpose of AdvaMed’s India Code Certified Logo?

AdvaMed’s Board of Directors has embraced an ongoing commitment to promote ethical interactions among medical technology manufacturers and health care providers. The Logo is a visible symbol of medical technology manufacturers’ commitment to the AdvaMed India Code and will let health care professionals know at a glance that they are dealing with a company that strives to meet the ethical standards reflected in the AdvaMed India Code and has an effective compliance program in place.

Q: How may I use the AdvaMed India Code of Ethics Logo?

Licensees may use the AdvaMed India Code of Ethics Logo on print or electronic materials to represent their commitment to an effective compliance program and ethical interactions with health care providers. For example, licensees may print the logo on annual reports, promotional material, business cards, stationery and conference banners and signs. The logo may not be used in a manner or associated with text that implies that AdvaMed has endorsed or approved a licensee’s products, technology or individual compliance plan or practices.

Q: How do I obtain the right to use the AdvaMed India Code of Ethics Certified Logo?

A member or non-member medical technology manufacturer may obtain a two (2) year right to use the AdvaMed India Code Certified Logo upon submission of a Certification / Renewal Certification and a properly executed AdvaMed India Code Certified Logo Agreement. Non-member companies must pay a Royalty Fee ($300 / year).

Q:  Is there a fee for member companies to license the AdvaMed India Code Certified Logo?

No. Use of the logo is an AdvaMed member company benefit, following completion of the certification / re-certification process

Q: Who must execute the License Agreement?

The Chief Compliance Officer (CCO) (or equivalent) of the legal entity seeking the license must sign and date the License Agreement. For non-India companies, the License Agreement may be signed by the highest ranking India corporate executive having authority over the company’s India compliance operations. The CCO may wish to consult with legal counsel regarding the implications of licensure prior to signing the License Agreement.

Q: What if I have a complaint about a company using the AdvaMed India Code Certified Logo?

For any questions concerning a Member’s compliance, you may contact the company’s Corporate Compliance Officer, whose contact information is available at:

www. advamed.org/IndiaComplianceContacts