○ Draft for establishment

Article 2 Designation of information agency The Minister of Health and Welfare may designate the agencies equipped with below-shown condition as information agencies.

1. The agency shall have exclusive personnel to collect, store, and analyze the information on domestic/foreign innovative medical device R&D and have a designated information manager.

2. The agency shall have facilities and equipment for professional management of information on domestic/foreign innovative medical device R&D.

3. The agency shall have the personnel and organization to collect, store, and analyze the information on domestic/foreign innovative medical device R&D.

? When the content in the designation certificate is changed, the information agency shall immediate notify the changed content to the Minister of Health and Welfare and shall obtain the reissued designation certificate.

○ Reason for establishment

The purpose is to support encouragement of medical device R&D activities by managing and distributing related information with integration and systemization with designation of innovative medical device R&D development information agency in accordance with Article 26.1* of Act on Support of Medical Device Industry and Innovative Medical Devices to be established.

* The Minister of Health and Welfare may the agencies for professional management of information on innovative medical device R&D development (Article 25.2 of the Act).

It is intended to support establishment of policies and enterprises’ R&D activities in relation to medical device industry by improving the quality of professional agencies and by managing and distributing information with integration and systemization with establishment of the conditions of the agencies/organizations to be designated as innovative medical device R&D development information agencies.