U-Healthcare Medical Device? Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner. Recently, the Ministry of Food and Drug Safety published guidelines for quali..

In order to receive MFDS ClassII certification, technical document review by technical document review agency is essential. Currently, the fee for reviewing technical documents for second-class medical devices has been frozen for 13 years, resulting in a vicious cycle of worsening management of review institution, delayed complaint processing periods, and deterioration of civil service. To refle..

AVNISA, Brazil's medical device regulator, updated IVD regulations to RDC 830/2023. The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates risk classifications and regularization procedures across all IVD risk classes, rendering the previous RDC 36/2015 obsolete. The main changes are as follows. - Provide process (notification and registration), ANVISA forms to p..

DBT of UK has updated product manufacturing guidelines in Northern Ireland market. Main updates are as follows: 1) EU DoC: When a product has the UKNI mark next to the CE mark, the EU DoC is still required. 2) Unrestricted access to Northern Ireland’s Businesses: This policy permit products that meet the Northern Ireland standards to enter the UK market without additional approvals. 3) UKNI Mark..

BEE of India has brought in the Standards and Labeling Program for Solar Panel. Period of this program will be from 1st January2024 to 31st December 2025. Photovoltaic solar modules will be operated voluntarily until further notice at first. Labelling fees for 4 and 5-star rated solar PV modules have been waived off till 31st December 2025 to encourage the production of efficient solar panels. A..

On December 07, 2023, ENACOM published Resolution 207/2023, which approves new Technical Standard ENACOM-Q2-61.03 V23.1 repealing ENACOM-Q2-61.03 V17.1. According to the new standard, 5G NR is allowed to in a new frequency band n78 (3300-3700 MHz). Until at least 2 accredited laboratories are authorized to carry out 5G NR Testing, Test reports issued by an accredited foreign laboratory will be a..

On December 13, 2023, The Federal Communications Commission today proposed that 100% of wireless handsets— namely mobile phones and smartphones—offered for sale in the United States be fully compatible with hearing aids. The Commission Will Take Comment on Next Steps Including Leveraging Advances in Bluetooth Technology. Refer from: https://docs.fcc.gov/public/attachments/DOC-399084A1.pdf

TRC adopted a draft “instructions Obtaining specific approval for telecommunications devices and organizing their entry into the Kingdom” and opened a public consultation on the draft. Main Updates are as follows: (1) The validity period of the Type Approval certificates is changed from 3 years to 1 year validity. (2) If there is not a change in the device, renewal device submissions is allowed ..

On October 4, 2023, the Republic of Moldova has announced the updated National Frequency Bands Allocation Table in the National Official Journal. Main Changes to National Frequency Bands Allocation Table are as follows: ■ Railway Mobile Radio Networks : From January 1, 2024, the 874.4-880 MHz frequency band paired with 919.4-925 MHz and the 1900-1910 MHz frequency band will be used for non-exclu..

On November 21, 2023, ANATEL published Official Letter 429/2023/ORCN/SOR-ANATEL, which is the guidelines on accepting test reports from abroad under Act No. 7280/2020. According to the Letter, the obligations contained in Act No. 4083/2020 are valid for any test reports and Brazilian standard, on the distribution voltage and its frequency, should be followed in the tests carried out. The obligat..