The 55th Policy meeting was held on October 31, 2018, presided by Prime Minister Nak-yeon Lee. This conference was attended by the heads of administrative agencies, such as the Ministry of Health and Welfare(MHW) and the Ministry of Food and Drug Safety(MFDS), to discuss and confirm the 「Comprehensive Negative Regulatory Transition Performance Results and Future Plans」. 1. Comprehensive Negative Regulatory Transition
The comprehensive negative regulatory transition is a transition into a ‘approve first – regulate later’ system for new businesses by changing the existing positive method of regulation, which requires that new technology must either comply with regulations that already exist (which are not compatible with the new technology) or wait for the government to devise rules that specifically allow that new technology. Under the negative regulatory framework, the new technology can enter the market with relevant changes in regulations to follow, as necessary. By drastically reducing the time it takes for new technology to enter the market, the reform hopes to strengthen emerging business sectors that are driving the 4th industrial revolution. 2. Regulatory Innovation in the Field of Medical Devices
The medical device sector is the main target industry of the comprehensive negative regulatory transition. On July 19, 2018, the relevant government agencies made a joint announcement on 「Regulatory Innovation in the Medical Device Industry and Measures to Promote Industry Development for Innovative Growth and Expansion」. Among the key stated objectives of the regulatory innovation in the medical device industry is the ”Introduction of Comprehensive Negative Regulation for Safe Medical Devices.” And with respect to IVD medical devices, the plan is to (1) switch the evaluation of new medical technology from pre-market evaluation to post -market evaluation, and (2) exempt the approval requirement for changes except for those that are significant. 3. Comprehensive Negative Regulatory Transition for IVD Medical Devices
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