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Blog Image 15 Jan, 2024

We are now live on E-Commerce platform…

Follow us on Amazon, Flipkart and Tata 1 Mg an E-commerce platform. https://amzn.in/d/8jcbwHL https://www.1mg.com/otc/medelite-nitrile-disposable-examination-glove-large-black-otc990902 We are now on Amazon, Flipkart and Tata 1 Mg to ensure that our products are directly reach to end user at best rate in Industry. Following Products are listed on platform. Medical Gloves Surgical Mask Infusion Set Lab coat –… Continue reading We are now live on E-Commerce platform…

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Blog Image 20 Aug, 2023

Further amendment to lists of harmonised standards with presumption of conformity to European medical devices regulations

The European Commission has published the second amendments to the lists of harmonised standards in the Official Journal of the European Communities (OJ). Harmonised standards listed in the OJ provide a presumption of conformity with the with relevant requirements of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) covered by… Continue reading Further amendment to lists of harmonised standards with presumption of conformity to European medical devices regulations

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Blog Image 04 Jun, 2023

About Indian Medical device

In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945. (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause… Continue reading About Indian Medical device

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Blog Image 16 Apr, 2023

Licensing regime for Class C and D non notified medical devices

It is now prominent that in order to maintain market access starting on 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭, 𝟮𝟬𝟮𝟯 all Class C and D medical devices must obtain a #license (Manufacturing/Import). According to GSR 102 (E) dated February 11, 2020, the mandatory registration phase is currently in effect for non-notified Class C and D devices.  The #CDSCO office has issued a circular… Continue reading Licensing regime for Class C and D non notified medical devices

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