On December 26, 2023, IFETEL of Mexico published guidelines for the use of the IFT Seal for telecommunications or broadcasting products, which will come into effect 180 business days from the publication. Through these guidelines, IFETEL presents requirements that approval certificate holders, subsidiaries and importers must comply with when using the seal. Details of the label usage guidelines ..

China's SRRC announced a notice on Strengthening and Standardizing Matters Related to Radio Management in the 2400MHz, 5100MHz and 5800MHz Frequency Bands, which has been implemented from the announced date. According to the notice, WLAN equipment, which adopts the IEEE802.11be, should comply with the requirements on Multi-Link Operation (MLO) characteristics, Multi-Resource Unit (MRU) spectrum ..

The new SAR standard for mobile communication devices GB 21288-2022, which replaces the old standard, GB 21288-2007, has been implemented from January 01, 2024. Therefore, all mobile communication devices, operating within 100 kHz ~ 300 GHz and used within 20 cm of the human body, should now comply to the new standard, GB 21288-2022. The main technical changes are as follows: 1. Scope The scope ..

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..

On December 4, 2023, the Chilean SEC announced the TV safety test protocol (PE No.8/1 2023). The standard for the updated protocol (PE No.8/1 2023) belongs to IEC 62368-1:2018 and will come into effect from June 30, 2025. The main points are as follows: The scope range of the updated protocol (PE No. 8/1: 2023) has been expanded to 65 inches TV. Certificates according to the existing protocol (P..

On October 23, 2023, DPIIT issued a Quality Control Order (QCO) that mandates ISI marks for door fitting. This order will take effect from April 23, 2024. The types of door fittings applied to ISI mark mandates are as follows:

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..

ブラジルの医療機器規制機関であるAVNISAはRDC 830/2023にIVD規制をアップデートしました。 2024年6月1日から発効される新しいRDCは、すべてのIVDリスクレベルにわたってリスク分類および正規化手順を統合し、以前のRDC36/2015を使用しなくなる改訂版です。 主な変更点は以下の通りです。 Ø プロセス(通知および登録)、通知および登録を請願するためのANVISA様式、申請書の検討、登録更新および修正、ラベル付け要求事項を提供し、提出された規制文書は英語、スペイン語またはポルトガル語で作成することができます。 Ø IVD分類およびIVDをデバイス製品群にグループ化するのにも若干の変更が生じ、分類ルールをより明確にするためにフレーズアップデートに関連する変更が行われました。 Ø 技術文書またはdossiêtécnico提出の構成はAnnex IIに記載されており、提..