There was a national shutdown at ICASA offices from September 27, 2023, which have negatively influenced on delivery of Type Approval Certificates. The strike has been ended on October 10, 2023, but the 2 weeks shutdown may still cause the delay on Type Approval because of workload issues.

MIIT issued a notice about IPv6 test on WLAN devices for SRRC approval on October 13, 2023. The key points to focus on are as follows: 1. Wireless LAN devices with public IP address allocation function should support the IPv6 protocol. 2. IPv6 wireless LAN devices should support and enable IPv6 address allocation function by default, while retaining the option for users to configure IPv6 address..

MIC has issued the circular, 10/2023/TT-BTTTT, which postpone application of partial/full implementation of some technical regulations in circular No. 04/2023/TT-BTTTT dated May 31 of 2023. Relevant enterprises are allowed to apply for Certificate of conformity in accordance with 04/2023/TT-BTTTT (with full technical regulations) or 10/2023/TT-BTTTT (without postponed technical regulations). At ..

CPSO has issued a circular, CPSO-070923-11, to clarify the testing and certification requirements for AC adaptors which can deliver more than 100W of power (>100W), under IEC 62368-1 as follows: 1. Requirements for AC Adaptors tested to IEC 62368-1:2018 and earlier a. Clause 6.6. of IEC 62368 (Ed. 3.0 and earlier) only allows for AC adaptors that can deliver >100W to connected equipment if the c..

On July 21 of 2023, the order “The Bolts, Nuts and Fasteners (Quality Control) Order, 2023” has been issued. The scope of the order and applicable standards are as follows: Goods or articles Indian Standard Title of Indian Standard Bots, Nuts and Fasteners 1363 (Part 1):2019 Hexagon Head Bolts, Screws and Nuts of product Garde C Hexagon Head Bolts (Size Ragne M5 to M64) 1363 (Part 2):2018 Hexago..

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices. Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK..

ANVISA, Brazil's medical device regulator, issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Declaration and Registration of Medical Devices, the amendment effective August 18, 2023. The revised content allows the import of medical devices and accessories if the manufacturing date is earlier than the date of declaration or registration. Note that the period between the manufacturi..

The Cosmetics Regulation Modernization Act (MoCRA) is important to the chapter VI of the Federal Food, Drugs and Cosmetics Act (FDCA) and adds new information (GMP, safety proof, critical adverse event reporting, facility registration, product registration, additional labeling marks, record keeping, etc.). It also gives the FDA the authority to order compulsory recalls. MoCRA's facility registra..

With the development of information and communication technology, the number of wired and wireless communication medical devices is increasing. As a result, cases of cybersecurity threats such as hacking and information leakage are steadily increasing. For this reason, the application of cybersecurity in medical devices has been strengthened because it can directly harm patient life. Medical dev..