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【 USA 】 FDA Laser Notice No. 50 Withdrawal

On June 7, 2023, the U.S. FDA made an announcement regarding the withdrawal for FDA Laser Notice No.50, set to take effect by the end of 2024.
Manufacturers currently utilizing FDA Laser Notice No.50 for their laser products are required to transition to FDA Laser Notice No.56 by the end of 2024.
The replacement notice, FDA Laser Notice No.56 aligns with standards outlined in IEC 60825 1 Ed. 3 and IEC 60601 2 22 Ed. 3.1.
After 2024, Laser products manufactured in 2024, certified to the FDA requirements using Laser Notice No.50, and labeled with a 2024 manufacturing date, are acceptable. However, the same laser products manufactured in 2025 and labeled with a 2025 manufacturing date cannot use Laser Notice No.50 they will need to use Laser Notice No. 56 or the 21 CFR 1040.10/1040.11 requirements instead.

NCC Low Power RF Technical Specifications Updated 113 version

On February 6, 2024, the LP0002 113 version of the Low Power  Radio Frequency Equipment Technical Specification was released. Mainly for the addition of Chapter 5.13 for Wi-Fi 6E, with no changes to other content.

The application process is as follows:

LP0002
Buffer regulations Before December 31, 2024 Finial acceptance date for version 109

 

From January 1, 2025, Finial acceptance date for version 109 Only 113 Version of the standard can be accepted
WIFI6E(5945~6425MHz)
Buffer regulations Before June 30, 2024 The final submission date for adopting EN303687 From July 1, 2024 Only applications for inspection under LP0002 are acceptable
Inspection unit Regulatory Authority (NCC) NCC Recognized Certification Body (RCB)
Note The delivery method adopts a two-stage delivery method.

The Regulatory Authority will open the submission hierarchy from time to time. (Currently, the first-tier NCC only accepts RCB submissions for three projects)

Only RCBs with inspection qualifications are eligible to process inspection applications.

【Reese’s Law】Household Products with Built-In Button Batteries Must Comply with UL4200A Testing Requirements

In a proactive measure to prevent injuries and fatalities among children caused by accidental ingestion of button batteries, the U.S. government has enacted legislation known as Reese’s Law on September 21, 2023, set to take effect from March 19, 2024. Products incorporating button batteries and intended for use in general household environments are mandated to adhere to the product safety regulations outlined in UL4200A before being imported into the United States.

Wendell Electrical Testing Co., Ltd. stands ready with UL4200A testing capabilities and is well-equipped to conduct relevant tests for your products. This ensures that your products can be deployed ahead of the mandatory decree date (March 19, 2024), allowing you to ship with confidence.

Wi-Fi 6E new news by NCC

MINISTRY OF DIGITAL AFFAIRS Notice is hereby given, for the amendment of “Radio Frequency Supply Plan” (amendment becomes effective from 25th, August 2023)

○Announcement of 5945-6425MHz for Wi-Fi 6E use.

 

Technical specification for Low Power Radio Frequency Devices LP0002 is under revision and will be published by the end of 2023.

 

Before the 5945~6425MHz band is incorporated into LP0002, or LAB/RCB has not been accredited by TAF, NCC issues approval certificates through two-stage inspection with test reports issued according to the latest version of ETSI EN 303 687 V1.1.1.

BSMI will adopt CNS15936:2016

BSMI will adopt the latest version of the electromagnetic compatibility inspection standard, CNS15936:2016 to ensure consumers’ safety.

Taiwan Standard Harmonized IEC standard
CNS 15936:2016 CISPR32: 2015 2nd edition

NCC certification update antenna data request

NCC Conformance Meeting – Conclusion No. 11112502

The requirements for NCC certification antenna data have been updated (refer to FCC requirements). The NCC certification should submit antenna specification technical documents or antenna test reports (Antenna Test Report, AUT Report)

According to FCC KDB 353028 and FCC TCB Work Shop Part 15 Antenna Update on October 26, 2022.

Antenna datasheet needs to indicates following information:

manufacturer name/address, antenna type, brand, model, operating frequency band and Gain value, 2D or 3D diagrams, antenna photos or drawings, etc.

Report and Order 22-84 – FCC requiring two new attestation statements to be provided

On November 25, 2022, the commission adopted new FCC requirements to protect the nation’s networks and supply chains from equipment (“covered” equipment). The new rules provide a permanent prohibition to process/grant entities listed on the FCC Covered List.

Covered List:https://www.fcc.gov/supplychain/coveredlist

 

On January 24, 2023, the FCC Published KDB 986446. TCBs are expected to exercise appropriate diligence to prohibit granting of “covered” equipment. All FCC Equipment Authorizations granted by TCB’s henceforth, need to include the following two attestation letters:

 

On February 6, 2023, the final rules were published in the Federal Register and are, therefore, effective from today.

UKCA issued the newest “Guidance – Placing manufactured products on the market in Great Britain” – Prototypes and testing samples do not require UKCA marking.

Prototypes which are not yet made available for distribution, consumption or use on the GB market do not require UKCA marking. However, the prototype must only be displayed or demonstrated under controlled conditions at trade fairs or exhibitions in GB. This means the product needs to be operated by experts, there must be restricted public contact with the product, the product must not interact inappropriately with other neighbouring products, and it must be clearly indicated on a sign that the product does not meet the GB requirements and will not be made available until it does.

Products undergoing testing or validating pre-production of units do not require UKCA marking. They are still considered to be in the stage of manufacture and therefore have not been placed on the GB market.

However, fully manufactured products intended for consumer testing need to meet the UK requirements as they apply in GB at the time the consumer testing takes place.

UKCA updated

The deadline for when businesses need to use the UKCA mark has been extended. All goods which previously required the CE marking can continue to use the CE marking until 31 December 2024.

China MIIT issued the notices of updated technical requirement for wireless devices that operate at the bands of 2400MHZ, 5100MHZ and 5800MHZ on Oct. 13th, 2021.

China MIIT issued the notices of updated technical requirement for wireless devices that operate at the bands of 2400MHZ, 5100MHZ and 5800MHZ on Oct. 13th, 2021.  In order to increase the compatibility between wireless devices and facilitate more efficient of frequency resource, from Jan. 1st, 2022, China SRRC approval will require the adaptivity (Channel Access Mechanism) testing. Referring to the clause 4.2.7 of EN 301 893, this will require complicated setting of testing environment and normally require repeated debugging procedure. Consequently, testing time and cost will be increased thereafter.

ESG