News (314) 썸네일형 리스트형 MFDS July 2024 Medical Product Approval Update: 126 Items Approved Korea MFDS UpdatesIn July 2024, the Ministry of Food and Drug Safety (MFDS) approved a total of 126 medical product items. These approvals include: • 22 Pharmaceuticals • 2 Quasi-drugs • 102 Medical Devices Curious about how the July medical product approvals compare to last month or last year? Check out the details, along with more information on the latest regulations and updates regarding Kor.. The transfer of the Computer Energy Efficiency Management System is planned The transfer of the Computer Energy Efficiency Management System is planned Starting from January 1, 2025, the production (import) and sale of computers that do not meet the minimum energy efficiency standards will be prohibited. Additionally, an efficiency label (indicating compliance with minimum energy efficiency standards) must be affixed to the products. Scope of Application:This regulation.. KC EMC Certification Marking The following marking requirements apply to equipment that has received KC EMC certification: 1. Equipment with Certification of Conformity, Registration of Conformity, Interim of ConformitySuch equipment must have the conformity assessment marking (including the KC mark, certification or registration number, company name, product name, model number, manufacturing date, manufacturer, and country.. Opening of the 19th International Standards Olympiad Opening of the 19th International Standards Olympiad The world’s only international standards competition for youth, aimed at nurturing future talent, has begun. The Korean Agency for Technology and Standards announced the 19th International Standards Olympiad finals, with 120 students from 11 countries, including Korea, Japan, China, and Singapore. This year's International Standards Olympiad s.. Korean MFDS Amends the Medical Device Act Enforcement Rules On August 7, the Ministry of Food and Drug Safety (MFDS) made significant revisions to the Medical Device Act Enforcement Rules. These updates, effective from August 7, 2024, bring several key changes. 🔹 All Class 1 medical devices will be unified under a notification system. 🔹 Exemptions from clinical trial plan approvals will be expanded. 🔹 Participation criteria for non-clinical trial inst.. Post-Market Surveillance for Conformity Assessment Post-Market Surveillance for Conformity Assessment Products distributed in the market are collected and tested for compliance with technical conformity assessment standards. Through monitoring activities such as field investigations, compliance with obligations is examined, and administrative actions are taken in cases of violations. - Compliance with Technical Standards for Conformity Assessmen.. KC EMC | Conformity Assessment Marking • Certification of Conformity · Registration of Conformity Equipment Certification Number or Registration NumberR-XS-ABCD-XX∼XX① ②③ ④ ⑤ • Self-Conformity Verification Equipment Management NumberABCD-XX∼XX④ ⑤ ① Radio Waves Act② Approval type, “C” for certification, “R” for registration and “I” for Interim③ Only related to importers (Same equipment)④ Applicant code (3-digit or 4-digit)⑤ Produc.. Drone Delivery in Island Areas to Officially Launch in August Drone Delivery in Island Areas to Officially Launch in August The Ministry of Land, Infrastructure, and Transport announced that 14 municipalities, selected in March for the drone demonstration city project, have completed preparations for drone delivery. They will officially launch the K-Drone Delivery service starting in August. To ensure the safety of beyond-visual-line-of-sight (BVLOS) drone.. KC EMC | Changes to KC ID Applicant Codes As of July 24, 2024, the applicant identification codes for the KC ID in electromagnetic certification have been updated. These codes, previously fixed at 3 digits, have been modified to accommodate both 3 and 4-digit formats. To ensure uniqueness, each applicant code must be assigned without duplicating any existing codes and must be composed exclusively of a combination of letters and numbers... Korea Elected as the Inaugural Chair of the Indian-Pacific Economic Framework Crisis Response Network Korea Elected as the Inaugural Chair of the Indian-Pacific Economic Framework Crisis Response Network The Ministry of Trade, Industry, and Energy announced that the three implementation bodies of the Indian-Pacific Economic Framework (IPEF) Supply Chain Agreement have officially launched. Korea has been elected as the inaugural chair of the Crisis Response Network, which plays a key role during .. 이전 1 ··· 6 7 8 9 10 11 12 ··· 32 다음
