A list of recently updated articles regarding medical device regulatory updates from the CDSCO and other governing bodies in India.

Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit

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On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India’s largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, “Paving the way for a USD 50 billion MedTech Industry by 2030,” signifying a collective vision for the industry’s future growth.

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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 Launches Scheme for Promotion of Medical Device Parks

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The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).

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India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses

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Prior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.

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India’s CDSCO Expected to Begin Enforcing Local BIS Standards

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On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

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India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries

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On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

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India’s MOH Releases Draft Amendment to the Medical Device Rules 2017

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On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

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India’s CDSCO Temporarily Delays Implementation of UDI Requirements

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UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.

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