The Swissmedic guidance mandates the inclusion of CH-REP (Swiss Responsible Person) information on the labels of Class I MDR devices starting from 31st July 2023. The inclusion of CH-REP information on the labels of Class I MDR devices is now mandatory as per the guidelines provided by Swissmedic. This regulation aims to ensure transparency and accountability in the Swiss market and strengthen t..

From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. n India, medical device registration and regulations are governed by the Central Drugs Standard Control Organization (CDSCO), which issued the IMDR in 2017. Compliance wi..

Malaysia's MDA will be able to download electronic medical device registration certificates from May 2, 2023. Once the application is completed and the registration fee is paid, it can be downloaded from the MeDC@St2.0+ system. Electronic medical device registration certificates can be used to import medical devices or to launch them in the Malaysian market, The transition period to the former i..

In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Optional Screening Process Starting from July 1, 2023, the screening process for medical device registration applications will become optional. Applicants will have the choice to undergo the screening proce..

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..

On May 22, 2023, ENACOM published Resolution 756/2023, which finally allocates officially the 6GHz band for Wi-Fi, as known as Wi-Fi 6E. According to their previous public consultation in 2020, the lower portion of the band was allocated. After many studies and requests, however, the upper portion of the band has been also allocated. The summary of the resolution is as follows: Ø Allocated Frequ..

The following Standards were published on 2 June 2023 ● S 1869.0:2023 – Hose and hose assemblies for liquefied petroleum gases (LP Gas), natural gas and town gas, Part 0: General requirements ● AS 1869.1:2023 – Hose and hose assemblies for liquefied petroleum gases (LP Gas), natural gas and town gas, Part 1: Non-metallic liners ● AS 1869.2:2023 – Hose and hose assemblies for liquefied petroleum ..

As informed before, parallel testing for BIS certification was implemented as a pilot project with Mobile Phone from January 01, 2023 to June 30, 2023. As insufficient parallel testing cases were received during the period, however, the period of the pilot project has been decided to be extended for six months – upto December 31, 2023. In addition, it has been decided to add two more product cat..

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to soft (hydrophilic) daily wear contact lenses. The document further outlines specific criteria related to the safety and performance medical device manufacturers should take into consideration when placing their products on the mark..

Registration of medical devices is not mandatory in Hong Kong, but is a recommendation. However, Hong Kong Department of Health (DH) will implement a new strategy for medical device procurement from June 21, 2023. DH supports the Medical Device Administrative Management System (MDACS). Under the new strategy, DH purchases medical devices to meet international standards-like safety, quality and p..