On August 18, 2023, ENACOM has published Resolution 1132/2023 in the Official Bulletin of Argentina, which approves new versions of two standards – ENACOM-Q2-63.02 V23.1 “Equipment Integrating Systems of Broadband Digital Modulation” & ENACOM-Q2-63.03 V23.1 “Equipment Integrating Systems of Frequency Hopping”. The main changes are as follows: The Resolution gives 90 days from its publication in ..

According to 2022 medical device industry production and import/export statistics, It is an infectious disease diagnostic test reagent that ranked 1st in domestic production and export and accounted for 48.4% of exports. Diagnostic reagents are mainly used in in vitro diagnostic devices. In other words, the field of in vitro diagnostic devices, which has grown rapidly due to COVID-19, is expecte..

The class 1 application of medical devices is the most applicated class because it is a simple procedure compared to the certification and authorization procedures. The products that have recently been reported a lot with the first grade are as follows, and we will inform you of the brief reporting process and necessary documents. 등급 분류번호 품목명 1 A59060.01 a manual cervical extensor A01060.02 elec..

The UK Government has announced that their product safety laws, which are over 30 years old, are set to be overhauled in a bid to make them modernized. As part of the effort to modernize the regulations, OPSS has opened two new product safety consultations: Smarter regulation: UK product safety review Smarter Regulation: Fire safety of domestic upholstered furniture The consultations will seek v..

General of Foreign Trade of India has issued the Notification No. 23/2023, which amends import policy of items under HSN 8471 of Chapter 84. According to the notification, Import of Laptops, Tablets, All-in-one Personal Computers, and Ultra small form factor Computers and Servers falling under HSN 8471 (hereinafter 8471 products) shall be ‘Restricted’ and their import would be allowed against a ..

On July 26 2023, IMDA announced the planned cessation of Mobile Network Operators’ 3G network and provision of 3G services, with effect from 31 July 2024. With the impending cessation of the 3G network, IMDA will stop accepting new registrations and renewals of 3G-only mobile terminals and non-VoLTE capable mobile/smart phones (hereinafter 3G-only&non-VoLTE products) with effect from 1 November ..

The ‘Call to action’ banners before the main body of text about UKCA marking & relevant guidance has been updated to list the 18 sectors the CE marking will continue to apply to, which fall under the DBT: Toys Pyrotechnics Recreational craft and personal watercraft Simple pressure vessels Electromagnetic compatibility Non-automatic weighing instruments Measuring instruments Measuring container b..

The following Standards are out for public comment until 29 August 2023: AS 4617:2018 AMD 2 – Manually operated gas valves AS 4621:2019 AMD 2 – Regulator for use with liquefied petroleum – Vapour phase AS 4627:2017 AMD 3 – Quick-connect devices for gas If you would like to submit any comments, you may forward them directly through to Standards Australia – See following guide: Click Here Refer fr..

Updated good manufacturing practice (GMP) requirements for medical devices on the Mexican market have taken effect as of June 20, 2023. The latest version of Mexican Official Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices (hereafter NOM-241), published December 20, 2021, and coming into effect on June 20, 2023, establishes the minimum requirements for medical device..

TEC has issued the notification No. 5-2/2021-TC/TEC165 on June 23, 2023, which notifies the implementation schedule of the Phase-V of MTCTE as follows: Ø Acceptance of Applications on MTCTE portal : from July 01, 2023 Ø Certification becomes Mandatory : from July 01, 2024 The list of products under Phase-V of MTCTE are as follows: No. Product ILAC report acceptance 1. Base Station for Cellular N..