On February 10, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the “Regulation on Medical Device Groups and Class by Group”. The amendment introduces new subgroups for items that were previously managed under broader groups or require clear classification systems for safety management. The aim is to improve the efficiency of medical device safety mana..

Based on major complaints received through education and civil service counseling, customized support, and helpdesk to minimize confusion and difficulties in reporting supply details by NIDS, the "Civil Service Counseling Casebook for Reporting and Management of Medical Devices" was published on November 22, 2024. Medical device supply details report shall be submitted to the Minister of Food an..

On November 7, 2024, the Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on the Approval, Notification, and Review of IVDs.  The purpose of the amendment is to reflect minor changes in the Enforcement Rules of the In Vitro Diagnostic Medical Device Act, and to reasonably improve and complement the current system.  This includes expanding the recogniti..

When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.  The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.  For medical devices that do not require expert review for appr..

2024年10月14日、英国OPSSで発表された内容によると、化粧品に使用が禁止された「リリアル(Lilial)」成分が含まれたすべての化粧品を廃棄および禁止以後に販売された製品をリコールを考慮することを含みます リリアル(Lilial、Butylohenyl methylpropional)でユリの香りがする香料としてシャンプー、香水、ボディ製品などに使用されてきましたが、生殖毒性、内分泌系の撹乱などで安全性の問題に影響を及ぼすことが知られています。 これに伴い、国内食品医薬品安全処もリリアルの安全性問題を認識し、危害評価結果により原料使用基準を強化しており、該当内容は『化粧品安全基準等に関する規定』改正案(2024年8月2日行政予告)にその使用限度を全含量の0.14%に制限している内容を含んでいます。 食品医薬品安全処は行政予告を通じて意見収斂後、後続手続きを経て告示改正を完了する..

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..

PMDA (Pharmaceutical and Medical Device Agency) is a comprehensive pharmaceutical and medical device organization that aims to contribute to improving national health by guiding and examining the quality, efficacy, and safety of pharmaceuticals and medical devices, and collecting, analyzing, and providing information on safety after marketing. Japan's medical device classification system is base..

The Ministry of Health (MoH) of Republic of Indonesia issued circular no. HK.02.02/E/1753/2024 on September 9, 2024, to implement the Good Distribution Practice (GDP) certification as a requirement for the electronic catalog system, ensuring the safety, quality, and performance of medical devices.According to Government Regulation No. 28 of 2024 (implementing Law No. 17 of 2023 on Health), the k..

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 FDA published a revised MDSAP AUDIT APPROACH (MDSAP AU P0002.009) on August 6, 2024.The revision from MDSAP AU P0002.008 to 009 is briefly as follows. 1. Australia (TGA)As a result of changes to the Guidance for Australia (TGA) country-specific requirements, the following items have been revised or removed from the TGA requirements.1) Management - Task 5 & Task 82) Device Marketing Authoriza..