On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case. The medical device safety information management system is briefly as follows.1. If the medical device handler recognizes that death o..

The Ministry of Food and Drug Safety published ｢Guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices｣ on April 08, 2024 to help prepare biological evaluation data for medical devices by explaining the requirements, evaluation principles, and processes of data on physical and chemical characteristics ana..

MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control. From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve ..

According to the law below, Responsible sellers are required to report the 2023 cosmetics production performance to the Korea Cosmetic Association from January 1, 2024 to February 29, 2024. • 「Cosmetics Act」 Article 5 / Article 4 (Duty of business operator, etc.) • 「Cosmetics Act Enforcement Rules」 Article 13 (Report on production performance of cosmetics, etc.) • 「Regulations on the production ..

What is customized cosmetics? This refers to cosmetics in which a person with a dispensing manager license divides the contents of cosmetics or mixes the contents of cosmetics with raw materials determined by the Minister of Food and Drug Safety. According to the law below, a list of all raw materials used in customized cosmetics must be reported to the Korea Cosmetics Association by the end of ..

Medical device companies have many difficulties entering the market due to the cost and time required to obtain certification, the creation of enhanced technical documents, and the lack of information on essential regulations by country. Various organizations are carrying out many support projects to solve these difficulties, minimize the burden of certification barriers, and help them enter the..

U-Healthcare Medical Device? Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner. Recently, the Ministry of Food and Drug Safety published guidelines for quali..

In order to receive MFDS ClassII certification, technical document review by technical document review agency is essential. Currently, the fee for reviewing technical documents for second-class medical devices has been frozen for 13 years, resulting in a vicious cycle of worsening management of review institution, delayed complaint processing periods, and deterioration of civil service. To refle..

The Ministry of Food and Drug Safety has established an integrated guideline for authorization, certification, and examination of wound dressing (a guide to civil petitioners). The wound dressing material is manufactured in various forms, such as item shape, sheet shape, liquid shape, powder shape, etc., and is a medical device used to absorb exudate from wounds, bleed or lose body fluid, and pr..

Grundübersicht über die KC-Zertifizierung Country Guideline : Capital : Seoul Population : 51 millions Official language : Korean Currency : Korean won (KRW) Country Rating : Rated voltage : 220V Frequency : 60Hz Plug : Type C/F (KSC 8305) Um Elektro- und Elektronikprodukte, Haushaltsgeräte und Industrieprodukte in Korea zu verkaufen, ist die KC-Zertifizierung obligatorisch. Wenn Sie die KC-Zert..