メキシコの医療機器および体外診断医療機器は、メキシコ標準NOM-241-SSA1-2021に従います。 メキシコは危険に応じてClass I、Class II、Class IIIに分類され、すべての医療機器および体外診断医療機器は衛生登録が義務付けられています。 メキシコの医療機器および体外診断医療機器に関する規制当局は次のとおりです。 - 医療機器の評価、管理及び監視を担当する保健省（Ministry of Health） - 医療機器の輸出及び流通のための必須製品を認証する場所であるコペフリース(Cofepris) - 国民の疾病、負傷に対する予防、診断、治療等に対する保険を担当する社会保障保険庁IMSS (Instituto Mexicano del SeguroSocial) 医療機器および体外診断医療機器は、使用目的に応じて医療機器、人工物または補助器、診断団体の3種類に分類..

In the EU, cosmetic manufacturers and suppliers who want to sell cosmetics must comply with the requirements. Here are the following legal requirements for selling cosmetics in the EU market and the regulations on consumer safety protection and environmental responsibility. Labeling Requirements The EU's cosmetic packaging should contain key information such as product name, ingredient, content,..

Medical devices and in vitro diagnostic medical devices in Mexico comply with the Mexico standard NOM-241-SSA1-2021. Mexico is classified into Class I, Class II, and Class III depending on risk, and all medical devices and in vitro diagnostic medical devices must be registered mandatory sanitary registration. The regulatory authorities related to medical devices and in vitro diagnostic medical d..

2023年8月24日、公文書「The Solar DCCable and Fire Survival Cable(Quality Control)Order, 2023」が発表されました。 当該公文書に基づくBIS義務対象品目及び適用標準は次のとおりです。 Goods and Articles Indian Standard Title of Indian Standard Solar DC Cable 17293: 2020 Electric Cable for Photovoltaic Systems for rated voltage 1500 V DC Fire Survival Cable 17505 (Part 1): 2021 Thermosetting Insulated, Fire Survival Cables for working voltages up to ..

アルゼンチンの新しいブロードバンドおよびFHSS標準に関する前回のニュースに続き、 関連ニュースをお伝えします。 既存のWiFi 6E機能を 非活性化にした後、 承認を受けたWiFi 6E装置について、次のようなENACOMの回答を受けました。 Ø 既存の承認書を修正した後、WiFi 6Eを有効（活性化）にすることができます。 Ø 承認書の修正時にWLANおよびBT機能をすべて再試行し、すべての機能が新規バージョンの標準に準拠していることを証明する必要があります。 Ø 承認書の修正後も、ENACOM IDは同一に維持されます。

August 24 of 2023, the order “The Solar DC Cable and Fire Survival Cable (Quality Control) Order, 2023”. The scope of the order and applicable standards are as follows: Goods and Articles Indian Standard Title of Indian Standard Solar DC Cable 17293: 2020 Electric Cable for Photovoltaic Systems for rated voltage 1500 V DC Fire Survival Cable 17505 (Part 1): 2021 Thermosetting Insulated, Fire Sur..

Following up our last news about the new Broadband & FHSS standard in Argentina, we have an answer from ENACOM on the question about WiFi 6E devices which have already been certified after disabling WiFi 6E functionality: ■ WiFi 6E could be enabled on the certified products after certificate modification. ■ To modify the certificate, the whole WLAN and/or BT functions are required to be tested c..

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..