The Ministry of Food and Drug Safety announced a partial revision of the “Enforcement Regulations of the Medical Device Act” (Prime Minister’s Decree No. 1982) on September 20, 2024.
The contents of the Partial Amendment Decree of the “Enforcement Regulations of the Medical Devices Act” (Prime Minister’s Decree No. 1982) are briefly as follows.
<Reason for revision>
: Improvement and supplementation of deficiencies in the operation of the current system, such as preparing the basis for the reduction of civil service fees for related medical devices to ease the management burden of small business owners and support the use of medical devices for the visually and hearing impaired
<Revision contents>
In the proviso to Article 65 (1), "exempt" shall be exempted, and in any of the following cases, the fee may be reduced or exempted within 50/100, and the following subparagraphs shall be newly established in the same paragraph
1. In the case where the person subject to the fee under Article 10, No. 1 or 18 of the attached Table is a small business owner under Article 2 of the Small Business Basic Act, and the Commissioner of the Ministry of Food and Drug Safety determines that a fee reduction is necessary to alleviate the economic burden or support management stability, etc.
2. If the medical device that the person subject to payment of the fee pursuant to the provisions of Articles 3, 4, 5, 6 and 8 through 10 of Appendix 10 intends to manufacture or import includes a function that transmits usage information pursuant to Article 23-2, Paragraph 1, Item 2 of the Act by electronic means such as voice guidance or text enlargement, or is provided with software, devices, etc. for this purpose.
Please refer to attached document below.
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