Transition to a Negative Regulatory Framework 
for In Vitro Diagnostic (IVD) Medical Devices

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」.

3. Comprehensive Negative Regulatory Transition for IVD Medical Devices

Starting from January of 2019, the MHW will first begin by exempting the pre-market evaluation process for infectious disease IVD medical devices. The MHW has announced that it plans to eventually extend the exemption to all IVD medical devices.

The MFDS has announced its plan to exempt the approval requirement for changes for IVD medical devices, except for those that involve significant changes.

According to the current 「Regulations on Medical Device Approval, Notification, and Review」 (MFDS Notification No. 2018-59), the 140 items in 10 different categories listed under [Attachment 3] ‘Minor Changes’ are exempt from approval requirement for changes.

However, the MFDS plans to amend 「Regulations on Medical Device Approval, Notification, and Review」 so that, beginning February of 2019, (i) the approval requirement for all changes that are not significant will be exempted, and (ii) manufacturers and importers only have to report to the MFDS after-the-fact for such non-significant changes.

As a result of these amendments, it is expected that manufacturers and importers of IVD medical devices will be able to enjoy a cut-back of 2 or more months in the change approval process as well as a significant reduction in fees for change approval.