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cover item thumbnail MFDS Inspects Overseas Manufacturing of Medical Devices On-site due diligence at medical device overseas manufacturing sites The Ministry of Food and Drug Safety announced that 16 overseas manufacturing plants producing medical devices imported into Korea that are deemed to be in need of fact-checking on harm prevention and safety and efficacy information will be selected as targets for on-site inspections in 2024 and will conduct on-site inspections..
cover item thumbnail Obligations of the Minimum Energy Performance Standard Program Obligations of the Minimum Energy Performance Standard Program The MEPS (Minimum Energy Performance Standard) Program imposes three obligations on domestic manufacturers (for domestically produced products) and domestic importers (for imported products) to promote the spread of energy-saving products: labeling with energy efficiency rating labels, product reporting, and compliance with minimum e..
cover item thumbnail What is KC certification in Korea? Korea KC Certification KC stands for "Korea Certification" and is a mandatory certification system established by the Korean government to ensure that products manufactured in Korea or imported from abroad comply with domestic safety and technical standards so that only certified products can be distributed and sold. It plays an important role in ensuring the safety and performance of products i..
cover item thumbnail Changes are possible after safety certification application Changes are possible after safety certification application Manufacturers of safety-certified electrical products may make the following changes to their safety certification. If you make changes, you can apply for a safety certification change application by attaching documents that prove the change. Here's what you can change. - Name and address of the manufacturer of the electrical appliance ..
cover item thumbnail Korea and Indonesia Sign a LOI to Cooperate in the Electromagnetic Field Korea and Indonesia Sign Letter of Intent (LOI) The Ministry of Science and ICT announced on March 8 that it signed a letter of intent (LOI) with Indonesia's Ministry of Communications and Information (MCI) for cooperation on conformity assessment of broadcasting and telecommunications equipment. This letter of intent aims to confirm the willingness of the two countries to sign a mutual recognit..
cover item thumbnail Standards and Methods for Displaying Safety Certification Markings Safety certified products must display the KC mark on the product or packaging. The KC mark must be marked on the product or its packaging so that it can be easily recognized, and methods such as sticking, printing, or engraving can be used to prevent it from falling off. The method of displaying safety certificates, safety standards, and matters prescribed by the Director of the National Instit..
cover item thumbnail Improved Korean medical device import declaration MFDS, Improved Medical Device Import Declaration in Korea The Ministry of Food and Drug Safety and the Korea Customs Service have announced that the Medical Device Standard Pre-Clearance Notification, a pre-approval process required for importing medical devices, will become easier from 29 February. Previously, the complainant had to manually enter 13 types of medical device licence information ..
cover item thumbnail Application and processing procedures for safety certification of electrical appliances Application and processing procedures for safety certification of electrical appliances The safety certification system is a system in which a person who manufactures an electrical appliance subject to safety certification or who intends to export an electrical appliance manufactured in a foreign country to Korea must obtain safety certification for each model of the electrical appliance subject..
cover item thumbnail KC EMC Certification - Reporting Changes Without Testing KC EMC Certification For KC EMC certified products, even if components or other aspects are changed, a change notification without retesting based on the EMC compatibility assessment criteria is possible in the following cases. 1. If functionality in use is blocked or deleted using software without any hardware changes 2. In the case of changes related to electromagnetic compatibility criteria a..
cover item thumbnail KC EMC Certification - Mandatory Labeling Requirements KC EMC Certification Mark After obtaining KC EMC certification, the following information must be included on the product and packaging. 1. KC Mark 2. Certification No. 3. Conformity Assessment Information - Company Name - Product Name - Model Name - Manufacturing Date - Manufacturer - Country of Origin If it is not possible to display on the product and packaging, it can be indicated in the use..