Approval Fee for Newly Developed Medical Devices Raised from 1.49 Million to 98.43 Million Won

Approval and Review Period for Newly Developed Medical Devices Shortened from 80 to 60 Days
Fees Significantly Increased to 98.43 Million KRW
Dedicated Review Teams and On-Site Inspections to Accelerate the Process
Up to 50% Fee Reduction for Small and Medium-Sized Enterprises
Unnecessary Regulations Eliminated for Rehired Quality Managers

For newly developed medical devices incorporating advanced technology, the review period after application will be shortened from the existing 80 days to 60 days, giving them priority over other medical devices. The fees required for approval and review will be significantly increased to 98.43 million KRW, which is higher than that for general medical devices.

The Ministry of Food and Drug Safety announced on the 1st that it has revised and promulgated the 'Enforcement Rules of the Medical Device Act' to promote the development of newly developed medical devices and to establish customized approval and review support measures.

Newly developed medical devices refer to products that apply at least one of the following for the first time domestically compared to already approved products: mechanism of action, performance or intended use, raw materials, or method of use. Systematic support is necessary to expand treatment opportunities for the public and to secure market leadership for the domestic medical device industry.

According to the revision of the enforcement rules, the review period for approval of newly developed medical devices will be shortened from the existing 80 days to 60 days. The Ministry of Food and Drug Safety plans to conduct priority on-site inspections when applying for conformity assessment of medical device manufacturing and quality management standards (GMP), processing the review within two-thirds of the average review period.

Additionally, when applying for approval of newly developed medical devices, a dedicated team for each review field will be formed within 7 days from the date of receipt, and a visiting approval and review system will be established by supporting approval and review through meetings between the dedicated team and the applicant.

The approval and review fees for newly developed medical devices will be increased to 98.43 million KRW by applying the beneficiary pays principle, compared to the same fee as general medical device approval and review (1.49 million KRW). Based on this, the Ministry plans to hire additional highly capable reviewers to strengthen the expertise and speed of approval and review.

However, considering that most medical device manufacturers are small-scale and operate as small and medium-sized enterprises, the approval fee will be reduced by up to 50% for SMEs applying for approval of newly developed medical devices.

The revision also includes provisions to eliminate unnecessary regulations by exempting repeatedly submitting qualification verification documents when a person who has already been confirmed as a quality manager for medical devices is re-employed as a quality manager at another company.