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Medical Device Registration in India | CDSCO License Guide

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  According to CDSCO regulations, manufacturers and importers of medical devices in India must register their devices. Compliance guarantees both market entry and patient safety, from obtaining a CDSCO Import License to obtaining a Medical Device Manufacturing License. For manufacturers of medical devices, this guide streamlines CDSCO Certification and Registration. Introduction A start-up from Bangalore came to me a few months ago with the audacious plan to introduce AI-enabled diagnostic equipment in Indian hospitals.Their prototype was impressive, but their excitement turned into worry when they discovered the maze of CDSCO Medical Device Registration . Actually, proving that your product is safe and reliable and conforms with the Central Drugs Standard Control Organization (CDSCO) is necessary to obtain a CDSCO Import License or a Medical Device Manufacturing License. Without it, it is illegal to sell even the most advanced medical equipment in India. To help you avoid delays, ...

BIS Compliance for Shampoo Products

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BIS compliance for shampoo products ensures that shampoos sold in India conform to the safety, quality and labeling requirements of IS 4011:2018.  It covers the safety of ingredients, microbiological purity, performance tests (pH, foam), and packaging requirements.  Obtaining BIS certification and the ISI mark includes the testing of products and a factory audit to show trust in the brand from consumers and as a means for the brand to remain compliant to legal standards. Introduction In India, BIS compliance for shampoo products brands do not just check a box when conforming to standards. To have something to point to, something to show a consumer, implies that the brand can be trusted and that the product has been confirmed for safety and effectiveness. The standard we are referring to which is of great importance to meeting this aspect of safety and efficacy while protecting the formulations, ingredients, microbial quality and consumer safety is IS 4011:2018 from Bureau of...

BIS Standards for EV Chargers

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In India, to manufacture, import, or sell EV charger equipment, a BIS certification under IS 17017 is mandatory, and compliance to the standards ensures safety and performance standards are fulfilled.  The IS 17017 standards encompass all varieties of EV chargers, such as Bharat AC-001, Bharat DC-001, and high-power chargers (includes CCS2 or CHAdeMO protocols under IEC 61851 and IEC 62196 standards).  Certification permits products by law to enter the Indian Market, participate in Government tenders/public procurement, and is expected to enhance customer confidence with the BIS Standard Mark.  Introduction  India is electrifying its roads faster than ever while ensuring safety and quality remains a priority. EV chargers are now subject to strict Bureau of Indian Standards (BIS) requirements under IS 17017, with regards to all aspects including connectors, communication protocols, safety requirements, and more. If you are manufacturing, importing, or installing EV ch...