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 and OtherOrganizations” (hereinafter “this Guideline”) and makes efforts to secure and improve thetransparency and credibility of the relationship with member companies and medical institutions andother organizations.
◆Member companies in the associations joining in JFMDA are strongly required to put patientsfirst as well as to practice transparent business activities rooted in a high level of ethics as acompany to take on part of the responsibility for health care.

◆For example, in order for medical devices to meet the needs of diagnosis, treatment and preventionof diseases, not only independent research and development by member companies but
collaboration with academic and other research facilities and medical institutions is indispensable.
However, for such industry-academia collaboration activities, conflicts of interest may arise insome cases.

◆Therefore, it is important to practice appropriate conflicts of interest management (COIManagement) and to secure the transparency of relationships with medical institutions and otherorganizations to gain a wider understanding and trust from society that a high level of ethics andtransparency is guaranteed in business activities of member companies.

◆Considering the above, JFMDA prepared this Guideline in 2012 and has publicly disclosed
information pertaining to funds, etc. paid to medical institutions and other organizations. JFMDA
has also striven to improve the transparency/reliability by reviewing this Guideline. As part
thereof, we revised this Guideline based upon full understanding of the purpose and objective of
the Clinical Trials Act which was enforced in April 2018.

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

Transparency Guidelines
for the Medical Device Industry
and its Relationships with Medical Institutions
and Other Organizations
1. Purpose
The purpose is to gain a wider understanding, by securing transparency and credibility of
the relationship with medical institutions and other organizations in the business activitiesof member companies, that the medical device industry can contribute to the developmentof medicine, medical technology and all life sciences as well as guarantee a high level ofethics in business activities.
Member companies shall use these guidelines to establish their own transparency
guidelines as standards for behavior.

2 Contents of publication(1) Disclosure Methods
The payments, etc. shall be disclosed through each company’s own website.
(2) Timing of Disclosure
The payments, etc. shall be disclosed within one (1) year after conclusion of each fiscal yearof each company.
(3) Targets of Disclosure
The payments, etc. in the previous fiscal year shall be disclosed in accordance with each itembelow.
A. Research and development expenses, etc.
Research and development expenses, etc. include expenses required forresearch/surveillance, etc. conducted under public regulations and various policies suchas the Clinical Trials Act and GCP/GVP/GPSP ordinances under the Act on Securing
Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Funds, etc. provided shall be disclosed as follows together with the annual total amountof each item.
● Specified clinical trial expenses (*1)
Name of receiving facilities (*2): number of cases, amount● Research expenses based on ethical guidelines (*3)
Name of receiving facilities (*4): number of cases, amount● Research expenses other than clinical trials (*5)
Total annual number of cases and amount, name of receiving facilities: number ofcases, amount● Clinical trials expenses (clinical study expenses)
Name of receiving facilities (*4): number of cases, amount● Post-marketing clinical trials expenses
Name of receiving facilities (*4): number of cases, amount● Device deficiency and/or infection disease reports expenses
Name of receiving facilities (*4): number of cases, amount● Post-marketing surveillance expenses
Name of receiving facilities (*4): number of cases, amount● Other research and development related expenses
Total annual amount

(*1)
(*2)

(*3)

(*4)

(*5)

“Specified clinical trial expenses” refer to expenses paid pursuant to a contract for a
specified clinical trial as defined in the Clinical Trials Act.
“Clinical trial identification number”, “facilities to which funds are provided”, “nameof medical institution conducting the trial” and “name of principal investigator”, etc.
shall be disclosed.
“Ethical guidelines” as used for the “research expenses based on ethical guidelines”
shall mean the “Ethical Guidelines for Medical and Health Research Involving
Human Subjects.”
For “name of receiving facilities”, “name of facility”, “name of organization in thefacility” and “department, role and name of an individual” will be disclosed based onthe contract.
“Research expenses other than clinical trials” refer to expenses required for researchother than a specified clinical trial, research based on ethical guidelines, clinical
trials, or post-marketing surveillance, etc., such as the so-called “basic research”.

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 promotion for learning or
research support, etc.
Funds, etc. provided shall be disclosed as follows together with the annual total amountof each item.
● Scholarship donations
Department, university: number of cases, amount● General donations
University (foundation): number of cases, amount● Academic conference donations
Conference name and number (area conference, research council): amount● Academic co-sponsoring expenses
Conference name and number, seminar name: amount(*This paragraph includes information obliged to be disclosed under the Clinical Trials
Act.)
C. Manuscript writing fees, etc.
This includes expenses, paid as consideration for lectures, writing or supervision of themanuscript and the consignment of services including other consulting, etc. to provide
information regarding the appropriate use of medical devices.
Funds, etc. provided shall be disclosed as follows together with the annual total amountof each item.
● 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, amount(*This paragraph includes information obliged to be disclosed under the Clinical TrialsAct.)
D. 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●E.

Expenses for the provision of medical/medical engineering-related literature, etc.
Total annual amount

Other expenses
This includes expenses for receptions and social courtesy.
● Reception expenses
Total annual amount21 Member Associations (about 4,300 companies)
As of April 2019

Japan Electronics and Information
Technology Industries Association

Japan Medical-Optical Equipment
Industrial Association

Japan Medical Industry Association

Japan Association of Medical DevicesIndustriesMedical Technology Association ofJapan



Japan Association of Health Industry
Distributors



Association of Japan Medical Devices
NetworkJapanese 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(Japanese alphabetical order)

The Japan Federation of Medical Devices Associations
8F-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 April 2019