India Changes Medical Device Application Processing System
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
Gunjan Verma is a Managing Partner at Asia Actual India, based in Gurgaon (National Capital Region – NCR), India. Previously, Gunjan was the Director- Regulatory Affairs and Quality Assurance at Zimmer Biomet India.
She holds a Bachelor’s Degree in Pharmacy from the Delhi Institute of Pharmaceutical Sciences and Research, Delhi University and completed her Post Graduate Degree in Pharmaceutics from the same institute. She also holds a Masters Diploma in Business Administration from Symbiosis Institute of Distance Learning, specializing in International Business. Starting at Win-Medicare Limited in year 1999, she moved through various assignments with increasing responsibilities at Baxter, Reckitt Benckiser and Zimmer Biomet. Her key area of interest is Regulatory Affairs and Commercial Quality Assurance for Medical Devices, In-vitro Diagnostics, Pharmaceuticals, Combination Products, Cosmetics, and Consumer goods.
In her previous assignments, Gunjan has led Regulatory Affairs, Quality Assurance, Advocacy and Policy Development initiatives as well as held additional responsibility for Integrity and Compliance facilitating the rollout of compliance initiatives and process changes, formulating new strategies for specific issues and negotiating resolutions. She is active in advocacy and engagement initiatives through industry bodies and is an author in the Boston Consulting Group (BCG) – Confederation of Indian Industry (CII) Report 2014 – Medical Technology Vision 2025 – A $50 Billion Opportunity for India. She is also a contributor to the BCG-CII Vision Report 2015 – The $50 Billion Opportunity – Making it happen for India.
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
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.
The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
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.
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.
India’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
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.
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.
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.
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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