The current Act bans manufacturers, importers, distributors, and lessors from providing money, articles, convenience, labor, entertainment or other economic benefits to medical personnel, the founders of medical institutions, and persons working for medical institutions for the purposes of promoting sales or lease for medical devices and imposes obligations to prepare and keep expense reports about provided economic benefits.

However, there is no basis to regulate business entities contracted by manufacturers, importers, distributors, and lessors to promote sales or lease of medical devices for providing economic benefits to medical personnel, the founders of medical institutions, and persons working for medical institutions, which has been pointed out as a shortcoming in managing the distribution of medical devices.

In this regard, this Act aims to ban business entities contracted to promote the sales or lease of medical devices  from providing economic benefits, require them to prepare expense reports about provided economic benefits, sentence them for up to 1 year in prison or up to 10 million won in fines for any violation, and require the Minister of Health and Welfare to launch a fact-finding investigation and disclose expense reports to strengthen the management of medical device distribution (Articles 13, 13-2, 18, 35-2, 53-2, and 54-2).

Article 13-2 (Submission, etc. of Expense Reports on Details of Provision of Economic Profits, etc.)