On November 11, 2024, the European Medical Device Coordination Group (MDCG) issued an update to the Questions and Answers on vigilance MDCG 2023-3, which includes a comprehensive update concerning the scope of in vitro diagnostic medical devices (IVDs) regulated under the IVDR 2017/746.  The revised guidelines of MDCG 2023-3, which include the IVDR, cover the following content.:  (1) The definit..

The FDA receives more than 2 million medical device reports (MDRs) annually related to deaths, serious injuries, and malfunctions of medica devices. Especially malfunction reports represent most of the MDRs received each year.  On August 28, 2024, the FDA announced final guidance for the Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. The VMSR program simplifies the rep..

The De Novo classification is an FDA regulatory mechanism used for new medical devices that are anticipated to be Class I or Class II with low risk when there is no suitable predicate device to claim substantial equivalence. The FDA announced the final guidance on the electronic submission template for De Novo (FDA-2023-D-3788) on August 23, 2024. This guidance includes on the use of the electro..

Taiwan TFDA announced on June 30, 2024 that it is implementing Good Manufacturing Practice (GMP) to ensure the quality of cosmetics, and GMP for cosmetics will be officially implemented from July 1, 2024. The manufacturing sites for sunscreens, hair dyes, perm products, antiperspirants, deodorants, and home-use teeth whitening products containing peroxide will be the first group required to comp..

MFDS2等級認証を受けるためには、技術文書審査機関の技術文書審査は必須です。 現在、2等級医療機器技術文書審査手数料は民間委託以後13年間審査手数料が凍結され、審査機関の経営悪化、苦情処理期間遅延、苦情サービス低下など悪循環がもたらされました。 手数料凍結による問題および他の業務の手数料引き上げ現況を反映して、2024.02.01から技術文書審査手数料が引き上げられます。 Category Current fee Increase fee Note New 1,400,000 2,464,000 Effective from 24.2.1 (10% VAT excluded) Change 1,100,000 1,936,000 Combination (New) 1,700,000 2,992,000 2024年2月から適用される第1段階の引き上げ手数料をご参考お願いします。 さら..

2023年9月12日、BEEは自社の標準およびラベル付けプログラムに関連して冷蔵庫に関する発表をしました。 BEEは、追加のお知らせがあるまで、メーカーと許可会社が自社の家電製品にQRコードを使用するようにする要件を一時的に猶予しました。 そのために承認書保有業者は製品のシリアル番号をBEEに知らせなければなりません。 この指針は、BEEの管轄機関の承認を得たものです。

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..

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..

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..

TISI has announced the update of 7 electronic appliances as controlled products as follows: Product Effective Date Updates Hair, Fur, or Skin Care Appliances up to 250V July 2024 - Applicable Standard to TIS 60335 Part 2 (23)-2564 (2021) - Additional requirements and tests to prevent heat generation & malfunctions Residencial Frying pan and Fryer up to 5L July 2024 - Applicable Standard to TIS 6..