JNM Global

Global Approval Partner

전체 글 2540

Chlie: SEC、TV安全規定プロトコルをアップデート

2023年12月4日、チリSECがTVの安全試験プロトコル(PENO.8/12023)を発表しました。 アップデートされたプロトコル(PENO.8/12023)の適用規格はIEC62368-1:2018に属し、2025年6月30日から施行されます。 主な内容は以下の通りです。 I. アップデートされたプロトコル(PENO. 8/1:2023)の対象範囲はTV65インチに拡大されました。 II. 新規プロトコル施行日から1年間、既存プロトコル(PE No.8/1:2014)による承認書使用が可能です。 (既存プロトコルは2026年6月30日以降に廃止されます) III. 施行日以前に新規プロトコルで承認を受けようとする場合、認証機関が新規プロトコルに対する承認を受けた場合に限り適用可能です。 IV. 既存のプロトコルに基づく承認書で通関を行った製品の場合、当該在庫がなくなるまで販売が可能..

JNM Japan 2024.01.18

India: BIS allow parallel testing for all Electronics and Information Technology Goods

As per JNM’s previous news, BIS had implemented parallel testing as a pilot project for certain period & 3 products categories – Mobile phones, wireless headphones, and Laptops. Based on the stakeholder’s consultation and consent from the Regulator, the bureau has now decided to convert the pilot project into a permanent scheme for all product categories under Electronics and Information Technol..

JNM Global 2024.01.17

Korea, List of medical device certification and approval support projects conducted in 2023

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..

MFDS, Published Guidelines for Application of Medical Device GMP Usability_U-Healthcare electrocardiograph

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..