Expansion of Medical Device Approval and Certification Procedure Acceleration Targets

[Asia Economy Reporter Byeon Seon-jin] The Ministry of Food and Drug Safety announced on the 14th an administrative notice of the revision of the "Regulations on the Operation of Preliminary Review of Medical Products," which includes expanding the scope of items subject to preliminary review and the range of data, and will accept opinions until the 4th of next month. The preliminary review system refers to the prior review of data required for item approval, notification, certification, etc., to expedite the commercialization of medical devices.

The Ministry of Food and Drug Safety decided to expand the preliminary review system, which was previously limited to newly developed medical devices and rare medical devices, to include medical devices requiring submission of clinical trial data and innovative medical devices. With the expansion of the preliminary review targets, it is expected that the commercialization period will be shortened for more than about 380 cases annually.

The scope of preliminary review data will also be expanded to include "data related to clinical trial plan approval" necessary for approval of clinical trial implementation, which is a stage prior to the approval application. Until now, it has been limited to "data related to technical documents," which are submitted at the product approval application stage. The Ministry of Food and Drug Safety will also subdivide the system so that preliminary review can be applied for with only some of the "data related to technical documents."

An official from the Ministry of Food and Drug Safety stated, "We will continue to actively improve regulations to strengthen the competitiveness of medical products."

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