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 CDSCO Releases Guidance for Renewing Medical Device Import Licenses

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India’s CDSCO has issued important guidance on the process for medical device Import License renewal. This process is newly coming into effect, as the first round of Import Licenses issued under the new Rules will start to expire this year.

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India Extends Deadline for Class C and D Import Licenses

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On May 16th, 2024 India’s CDSCO extended allowances for the importation of Class C and D Medical Devices currently under review.

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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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