As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..

According to the announcement made by the UK OPSS on October 14, 2024, all cosmetics containing the banned ingredient “Lilial” must be discarded, and the recall of products sold after the ban is being considered.  Lilial(Butylphenyl methylpropional), a fragrance ingredient that provides a lily scent, has been used in shampoos, perfumes, and body products, etc. However, it is known to raise safet..

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. : Improvement and supplementation of deficiencies i..

The Ministry of Food and Drug Safety (MFDS) has strengthened the labeling obligations on containers and packaging for certain cosmetics with small amounts of contents through the update of the “Enforcement Rule of the Cosmetics Act” Accordingly, on September 24, 2024, the MFDS newly established types of cosmetics with small volumes or weights that require labeling of precautions for use, and it ..

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は米国、日本、カナダ、オーストラリア、ブラジルの5つの正会員国が医療機器の安全と品質管理のために国際基準による共同審査を目的に作った認証制度です。 食品医薬品安全処は2023年12月19日付から医療機器共同審査プログラム(MDSAP)の審査結果、活用範囲の拡大および重複した提出書類の整備を通じて審査方法を改善し、医療機器の品質管理の国際調和を推進するために「医療機器製造および品質管理基準」の一部を改正しました。 主な改正事項は以下の通りです。 1) 第6条（適合性認定等審査方法） MDSAP適合認定書を保有している場合であっても、次の場合には、実地調査を実施しなければならない。 1.1 第四条第二項の規定による定期審査対象製造所 1.2 医療機器共同審査プログラムによる適合性認定等審査の結果、重大な不適合事項の発見等、国民の健康に影響を与えかねないと食品医薬品安全処長が認める..

The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024. Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the info..

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 ..