The CMDE under the National Medical Products Administration (NMPA) of China has issued guidelines for registration and review of high-frequency beauty devices (No. 8[2023]). Manufacturers of radio frequency beauty devices classified as Class III will have to comply with the new technical review guidelines from April 1, 2024. The High Frequency beauty device Registration and Review Guidelines (No..

On February 17, 2023, the NMPA in China made an announcement on the implementation of the 3rd Unique Device Identification (UDI) of medical devices. Depending on the degree of risk and regulatory needs, some Class2 medical devices, such as disposable products with high clinical demand, products selected for mass supply, and medical beauty-related products, are determined to be in the third batch..

On March 5,2024, MCMC of Malaysia had released the new class assignment, No.1 of 2024 which replaced the existing class assignment No.1 of 2023. This new class assignment came into effect on 5th March. Main updates of the new class assignment are as follows: 1) Nineteenth Schedule: Satellite Broadcasting Receiver Device - 12.443 GHz to 12.497 GHz was added to Receiver frequency for Berjaya Const..

On 9th March, ANATEL of Brazil issued the official Letter No.83. This Letter specifies the deadline for submitting the Test Report regarding the requirement for Cybersecurity assessment in CPE equipment. Main topics of the official Letter No.83 are as follows: 1. ANATEL will accept to grant approval to new devices and renewal certificates, not requiring the submission of the Cyber security Test ..

On 9th February 2024, SEC of Chile announced the Notice No.205286. The notice is about protocols for safety and efficiency Certification of electrical and fuel products released during 2023. The notice includes the following products: No Resolution Protocol Products Effective date 1 Re No.20049 09.11 2023 PE No1/41:2023 03.11.2023 Household Clothing and Towel Dryers 2025.03.31 2 RE No.20378 24.1..

NCC of Taiwan announced the updated ‘Low Power Radio Frequency Equipment’ Regulation on February 6, 2024 after a public consultation in December 2023. This announcement amended the Article 5 of the Regulation. This regulation took effect on 6th February, 2024. Details of the regulation are as follows: 1) Low power 5.945 GHz to 6.425 GHz devices are available for approval. 2) The devices should b..

MOIAT of UAE announced that applications for ECAS certification require to upload product photos for each model. Photos uploaded per model should include product photo, rating label, and packaging. Uploading additional photos are optional. This regulation for ECAS certificate took effect on 1ST March, 2024. But for time being it is voluntary to upload product photos in MOIAT portal webpage until..

FDA published a Quality Management System Regulation (QMSR) final rule on February 2, 2024 to revise the current good manufacturing practice (CGMP) requirements for medical devices in the Quality System (QS) Regulation (21 CFR Part 820). FDA amends Part 820 to incorporate the QMS requirements of ISO13485 as references. Replacing the Quality System(QS) with the Quality Management System Regulatio..

With the implementation of the revised Medical Device Management Enforcement Decree (98/2021/ND-CP) in 2021, Vietnam (MoH) extended the registration expiration date for Class C and D medical devices by one year to December 31, 2022, and made distribution registration mandatory from 2022. However, during that period, companies experienced a lot of inconvenience and confusion as the Ministry of He..

On January 15, 2023, Peru's INACAL issued Resolution 022-2023-INACAL/DN on technical standards for household appliances, electric motors, etc. This resolution came into effect on January 16, 2024. The resolution includes the following specifications: standard content remark NTP-IEC 60335-2-32:2023 (Safety) Household and similar electrical appliances. Part 2-32: Specific requirements for massage ..