Expert guides, updates, and compliance tips from Delhi NCR's leading medical device consultants. Stay compliant with CDSCO, EU MDR, USFDA & more.
On 31 October 2025, the Central Drugs Standard Control Organisation (CDSCO) issued a significant notification (F. No. MED-16014(12)/1/2024-eoffice-Part(2)) that...
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The latest regulatory notification on the Risk Classification of Medical Devices Pertaining to Interventional Radiology (IR) marks another important step in str...
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In a significant regulatory update (File No.: MED-16014(12)/1/2024-eoffice), authorities have issued a Risk Classification List of Medical Devices Pertaining to...
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In the ever-evolving landscape of healthcare regulation, India's Central Drugs Standard Control Organisation (CDSCO) plays a pivotal role in ensuring the sa...
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If you are planning to manufacture medical devices in India for sale or distribution, the process is now risk-based. The higher the risk class (A → B &rarr...
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The import of medical devices in India is governed by Chapter V of the Medical Devices Rules, 2017 (as amended). With the introduction of perpetual licensing (v...
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With the notification of the Medical Devices Rules, 2017 (amended from time to time) and the full implementation of Chapter-wise regulation of all medical devic...
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Focus on Chapter IV – Rule 49 to Rule 62 & Seventh Schedule (with reference to Rule 78E implications) The Government of India has brought almost al...
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India’s Medical Devices Rules, 2017 provide dedicated pathways for medical devices that have no predicate (i.e., no substantially equivalent device alread...
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In India, the Medical Devices Rules, 2017 (MDR 2017, notified as G.S.R. 78(E)) regulate every aspect of medical devices—from manufacturing and import to s...
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What is the difference between Scheme 1 and Scheme 2 for BIS certification? The Bureau of Indian Standards (BIS) operates two main certification schemes: Sch...
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Key Features of the MDR 2017: Comprehensive Coverage: The MDR 2017 provides a comprehensive regulatory framework that covers a wide spectrum of medic...
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To establish a robust regulatory framework that prioritizes the safety, quality, and efficacy of medical devices available in the Indian market. The MDR 2017 co...
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The Bureau of Indian Standards (BIS): Setting the Standard for Quality and Safety in India The Bureau of Indian Standards (BIS) is the national standards bod...
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