Tag Archive for: India

India Changes Medical Device Application Processing System

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On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.

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India’s Class C and D Import License Enforcement Deadline Fast-Approaching

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On April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close.

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India Issues Draft Notification for Exempting Certain Class A Medical Devices

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The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.

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India Issues New Sales License Requirement for Medical Devices

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On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.

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India Grants Import License Grace Period for Class A/B Devices

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Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.

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India Issues Final Notice Exempting Certain Class A Medical Devices

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On October 14, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.  

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India Requires Mandatory Local BIS Certifications for Certain Medical Devices

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This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.

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India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

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On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.

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An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases  

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In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.

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India Grants Import License Grace Period for Class C/D Devices

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On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.

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