From November 17, 2023, it has been partially revised to clarify administrative procedures by preparing standards and procedures for lifting the designation of medical devices subject to follow-up management and to match the name of the medical device subject to follow-up management with the item name specified in the Regulations on Medical Device Items and Classes by Item. The major revisions a..

During the festive period, here is the holiday closure dates of the regulatory agencies. Please keep this in mind when working with Africa agencies. PAYS/ AGENCES AGENCIES ANNUAL VACATION BURKINA ( ARCEP) December 11th: National Day (public holiday) December 25th: Christmas (public holiday) January 1st to January 3rd: Closed January 4th, 2024: Resumption TCHAD ( ARCEP) On 28/11/2023: Proclamatio..

On 25 September 2023, the DPIIT issued a QCO for Miscellaneous Steel Products. This regulation will come into effect from March 2024. The products which are mandatory for ISI Mark are as follows:

On 13 October 2023, ASTM published F963-23, revised standard regarding to Toy Safety. Numerous changes of these requirements were aligned with CPSC and federal regulations. This standard covers requirements and test methods for toy targeting children under 14 years of age. Requirements subject to the revised standard are as follows: 1) Sound-producing toys 2) Battery accessibility 3) Expanding m..

Based on the results of the risk assessment, the Ministry of Food and Drug Safety announced some revisions, such as adding some ingredients of hair dye to the list of raw materials that cannot be used in cosmetics and adding a chemical substance identification number (CAS No.) such as raw materials that cannot be used in cosmetics to increase the convenience of identifying raw materials. Please ..

India CDSCO introduced the Medical Device Rules (Medical Device Rules, 2017), Items subject to medical device registration have been expanded, and online applications for medical devices (SUGAM) have become mandatory. In order to enter the Indian medical device market, it is essential to check whether registration is required and the product risk level through the classification table. According..

The Central Drugs Standard Control Organisation (CDSCO) of India has issued a notice on October 25, 2023, updating several in-vitro diagnostic (IVD) classifications. These updates mean that all medical devices, regardless of class, must either be registered in India through the ePortal or receive an MD-15 import license before importing. The updated IVD classification is as follows. - Annex A fo..

TATT has issued Version 2.0 of Equipment Standardisation and Certification Framework for the Telecommunications and Broadcasting Sectors. The main changes are as follows: All certificates, including existing certificates are valid for 5 years from the date of issue. RX devices are exempt, except where such devices operate in RF frequency bands utilised by public safety agencies. Wired devices do..

RSS-252, issue 2, Intelligent Transportation Systems’(ITS) On-Board Units (OBUs) in the 5895-5925 MHz Band, replaces RSS-252, issue 1, Intelligent Transportation Systems – Dedicated Short Range Communications (DSRC) - On Board Unit (OBU) in the 5895-5925 MHz band. The main changes are listed below: 1. removed all sections from issue 1 2. added sections 1-5 to establish the technical parameters f..

IFT has issued an Agreement which modifies the Technical Provision IFT-011-2022: Technical Specifications of Mobile Terminal Equipment that can make use of the radio spectrum or be connected to telecommunications networks. Part 3. Cellular Broadcasting Service for notification of Risk or Emergency situations The summary of the agreement is as follows: 1. Restrictions of Usage of Channel for Rece..