2019年4月改定.pdf

The purpose of the guidelines is to ensure transparency and trustworthiness in the relationships between member companies and medical institutions, and to promote understanding of the medical device industry's contributions to the development of life sciences and its commitment to high ethical standards.

Member companies are expected to develop their own transparency guidelines based on these guidelines and disclose the following information:

1. Research and development expenses, including:
Specific clinical research fees
Ethical guideline-based research fees
Non-clinical research fees
Clinical trial fees
Post-marketing clinical trial fees
Adverse event and infection report fees
Post-marketing survey fees
Other research and development-related expenses
2. Academic research support expenses, including:
Scholarship donations
General donations
Academic conference support fees
Co-sponsorship fees for academic conferences
3. Manuscript writing fees, including:
Lecture fees
Manuscript writing and editing fees
Consulting fees
4. Information provision-related expenses, including:
Lecture and meeting fees
Explanation meeting fees
Provision of medical and medical engineering literature fees
5. Other expenses, including:
* Social courtesy and entertainment expenses

The disclosure should be made through the company's website and should include the total amount and number of instances for each category, as well as the names of the recipient institutions and individuals. The disclosure should be made within one year after the end of each business year.