On February 23, 2024, CDSCO(Central Drugs Standard Control Organization), through a circular, required all registered importers of cosmetic products in India to submit an annual declaration detailing the imported products from the date of approval of registration. Effective immediately from February 23, 2024, this directive is consistent with the regulations set out in the Cosmetics Rules 2020. ..

India CDSCO introduced the Medical Device Rules (Medical Device Rules, 2017), Items subject to medical device registration have been expanded, and online applications for medical devices (SUGAM) have become mandatory. In order to enter the Indian medical device market, it is essential to check whether registration is required and the product risk level through the classification table. According..

From February 28 of 2024, ISI certificate is required for Plywood and Wooden flush door shutters according to the relevant Quality Control Order. The scope of the order and applicable standards are as follows: Goods and Articles Indian Standard Title of Indian Standard Plywood and Wooden flush door shutters 303:1989 Plywood for general purposes 2202 (Part 1):1999 Wooden flush door shutters (soli..

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..

On July 21 of 2023, the order “The Bolts, Nuts and Fasteners (Quality Control) Order, 2023” has been issued. The scope of the order and applicable standards are as follows: Goods or articles Indian Standard Title of Indian Standard Bots, Nuts and Fasteners 1363 (Part 1):2019 Hexagon Head Bolts, Screws and Nuts of product Garde C Hexagon Head Bolts (Size Ragne M5 to M64) 1363 (Part 2):2018 Hexago..

2023年10月からインドではClass Cの医療機器を義務的に登録すれば、インド医療機器規則(IMDR)2017により品質管理システム(QMS)要求事項を遵守する必要があります。 インドで医療機器登録及び規定は2017年にIMDRを発行したCDSCO(Central Drugs Standard Control Organization)で管理されています。 IMDR Schedule V要求事項を遵守するということは、販売しようとしている医療機器の製造業者にとって必須的なものです。 IMDR Schedule V要件を遵守しなければ、登録手順の遅延及び罰金が付加され、市場から製品が回収される場合がございます。 医療機器製造業者がIMDR 2017を遵守するためには、下記の段階を実行する必要がございます。 - 装置部分を黄ばんでIMDR要求事項の識別 意図した用途、使用期間及びその他..

From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. n India, medical device registration and regulations are governed by the Central Drugs Standard Control Organization (CDSCO), which issued the IMDR in 2017. Compliance wi..

MHI of India issued an office memorandum to change the conformity assessment scheme in Electrical Equipment (Quality Control) Order, 2020 (hereinafter referred to as “EEQCO”). Formerly, the EEQCO was issued on 2020 to mandate that listed equipment bear the Standard Mark under a license from BIS as per Scheme-II in Schedule-II to the BIS (Conformity Assessment) Regulation, 2018. The implementatio..

CDSCO(Central Drug Standard Control Organization)はインドのNRA(National Regulatory Authority)です。 2021年1月1日から全てのX-ray機械はCDSCO医療機器の義務登録カテゴリーに属し、危険規範分類によってClass Cへ分類されます。 CDSCO 의료기기의 분류 Class Risk Involved Class A Low Risk Class B Low-Medium Risk Class C Medium-High Risk Class D High Risk X-Ray医療機器CDSCO登録手続き １．医療機器登録をするかしないかの判断 ２．医療機器危険規範分類 ３．インド公認代理店(IAA)指定 ４．技術文書の提出 ５．登録及び免許取得 CDSCO登録の所要時間 一般的に申請手続き完了..

The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India. With effect from 1st January 2021, All the X-ray machines fall under the category of mandatory registration of CDSCO Medical Devices. The X-Ray device is classified as a Class C medical device as per the Risk-based classification of the Medical Device Rules, 2017. CDSCO has set up differen..