Regarding Transparency Guidelines for the MedicalDevice Industry and its Relationships with MedicalInstitutions and Other Organizations
The Japan Federation of Medical Devices Associations (JFMDA) formulates “Transparency
Guidelines for the Medical Device Industry and its Relationships with Medical Institutions andOther Organizations” and makes efforts to secure and improve the transparency and credibility ofthe relationship with medical institutions and other organizations in the business activities.
◆Member companies in the associations joining in JFMDA are required to take its role tocontribute to the development and improvement of health care, by extension, the public health,welfare and the realization of quality of life through the development, manufacture, import andsale, etc. of medical devices, as well as to be deeply aware of that they must practice businessactivities rooted in a high level of ethics as a company to take on part of the responsibility for
health care.

◆ In order for medical devices to meet the needs of diagnosis, treatment and prevention of diseases,
not only independent research and development by companies but comprehensive researchthrough collaboration with academic and other research facilities and medical institutions(industry-academia collaboration) is indispensable and this industry-academia collaboration will
give birth to new effective and safe medical devices.
◆On the other hand, the industry-academia collaboration may be performed based on contracts
and other agreement with medical institutions and healthcare professionals and so on and there
have been cases where financial compensation are made in regard to those activities, andtherefore, it is incontrovertible that the chances arise for medical institutions and related
healthcare professionals to become deeply involved in a specific company or product and there
is concern over the possibility that this can affect fair judgment, so called, conflict of interest
may arise.

◆Therefore, for such industry-academia collaboration activities, companies are strongly required
to secure the transparency of relationships with medical institutions and other organizations.
Furthermore, it is important to gain a wider understanding and trust from society, by disclosing
information regarding funds, etc. paid to medical institutions and other organizations, that the
medical device industry are contributing to the development of medicine, medical technology
and all life sciences as well as guarantee a high level of ethics in business activities.

◆Recently, also in Japan, the Ministry of Education, Culture, Sports, Science and Technology, theMinistry of Health, Labour and Welfare, the Japanese Association of Medical Sciences havepromoted efforts for managing conflict of interest, as well as that the Japan Pharmaceutical
Manufacturers Association (JPMA) published its Guidelines for Transparency of Relationships
between Corporate Activities and Medical Institutions and, in light of these trends, JFMDA has
formulated these guidelines.

For promoting these guidelines, we hope that all of medical institutions and related healthcare
professionals will understand the aim of these guidelines and cooperate with us.
Japan Federation of Medical Devices Associations

Transparency Guidelines for the Medical Device
Industry and its Relationships with MedicalInstitutions and Other Organizations

1 The purpose is to gain a wider understanding, by securing transparency andcredibility of the relationship with medical institutions and other organizations in
the business activities of member companies, that the medical device industry
can contribute to the development of medicine, medical technology and all life
sciences as well as guarantee a high level of ethics in business activities.
Member companies shall use these guidelines to establish their own
transparency guidelines as standards for behavior.

2 Member Companies shall take account of the following points and aim for thetransparency of the relationship with medical institutions and other organizations.
(1) Stance of Member Companies
Member companies shall set forth their corporate policies for transparency of therelationship with medical institutions and other organizations, following in both word and spirit
the “Code of Ethics”, the “Charter of Business Behavior” and the “Promotion Code of theMedical Device Industry” which were established by the Japan Federation of Medical Devices
Associations as well as the “Fair Competition Code of the Medical Device Industry” which wasestablished by the Japan Fair Trade Council of the Medical Device Industry.
(2) Disclosure Methods
Member companies shall disclose funds and so on provided to medical institutions and otherorganizations during the previous fiscal year through their websites or other method after thesettlement of accounts of each company.
(3) Timing of Disclosure
Payments made during each fiscal year shall be disclosed in the next fiscal year. Provided,
however, that, with regard to A. Research and development expenses of (4) Scope of Disclosure,
only total annual amount is disclosed for those before and on fiscal year 2017, and total annual
amount and the details listed in (4) Scope of Disclosure are disclosed for those on fiscal year 2018
onward.
(4) Scope of Disclosure
A

Research and development expenses
This includes expenses for trials, reports, and surveillance studies conducted underpublic regulations (clinical trials, post-marketing clinical studies, nonconformity andinfection case reports, post-marketing surveillance studies, etc.) and those forindependent investigations.
● Joint research expenses(clinical) Name of receiving facilities (*1): number of cases, amount(other than clinical) Total annual number of cases and amount, name of receiving
facilities (*1)
● Contract research expenses(clinical) Name of receiving facilities (*1): number of cases, amount(other than clinical) Total annual number of cases and amount, name of receiving
facilities (*1)
● Clinical trial expenses

●

●

●

●

Name of receiving facilities (*1): number of cases, amountPost-marketing clinical study expenses
Name of receiving facilities (*1): number of cases, amount
Nonconformity and infection case reporting expenses
Name of receiving facilities (*1): number of cases, amountPost-marketing surveillance expenses
Name of receiving facilities (*1): number of cases, amount
Other research and development related expenses
Total annual amount(*1) For “Name of receiving facilities”, “name of facility”, “name of organizationin the facility” and “department, role and name of an individual” will be
disclosed based on the contract.

B

Academic research support expenses
This includes expenses for scholarships, general and academic conference donations aswell as academic conference co-sponsoring expenses to support for holding meetings
such as academic conferences conducted for the purpose of the promotion of learning or
research support for medical technology.
● Scholarship donations
Department, university : number of cases, amount● General donations
University (foundation): number of cases, amount● Academic conference donations
Conference number (area conference, research council): amount● Academic co-sponsoring expenses
Conference number, seminar: amount

CManuscript writing fees, etc.
This includes expenses for lectures, manuscript writing and the consignment of services
including consulting to provide information regarding the appropriate use of medicaldevices.
● Lecturers fees
Professor (director), department, university (hospital): number of cases, amount● Manuscript writing/supervising fees
Professor (director), department, university (hospital): number of cases, amount● Expenses for the consignment of services, including consulting
Professor (director), department, university (hospital): number of cases, amountD

Expenses related to information provisionThis includes expenses for lectures, workshops, seminars and so on necessary for
appropriate and safe use of medical devices given to healthcare professionals.
● Lecture expenses
Total annual number of cases and amount● Seminar expenses
Total annual number of cases and amount● Expenses for the provision of medical/medical engineering-related literature, etc.
Total annual amountE

Other expenses
This includes expenses for receptions and social courtesy.
● Reception expenses
Total annual amount21 Member Associations (about 4,300 companies)
As of March 2017

Japan Electronics and Information
Technology Industries Association

Japan Medical-Optical Equipment IndustrialAssociation

Japan Medical Industry Association

Japan Association of Medical Devices Industries

Medical Technology Association of Japan

Japan Association of Health Industry Distributors

Association of Japan Medical Devices
NetworkJapanese Association of Surgical Sutures

Japan Hygiene Products Industry
Association

Japan Medical Imaging and Radiological Systems
Industries Association

Japan Ophthalmic Instruments Association

Japan Contact Lens Association

Japan Condoms Industrial Association

Japan Home Health Care Association

Japan Dental Trade Association

Japan Analytical Instruments Manufacturers'
Association

The Japan Home-health Apparatus Industrial
Association

Japan Hearing Instruments Manufacturers
Association

Japan Hearing Instruments Dispensers
Association

Japan Industries Association of Physical Therapy
Devices

Japan Association of Clinical ReagentsIndustries

Japan Federation of Medical Devices Associations8F-B, Iidabashi Square Bldg. 3-2, Shimomiyabicho, Shinjuku-ku, Tokyo 162-0822
Tel.03-5225-6234 / Fax.03-3260-9092 http://www.jfmda.gr.jp
Revised in March 2017