India Launches Scheme for Promotion of Medical Device Parks
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).
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.
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).
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
In public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.
On September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021.
On March 25, 2021, a notification was released specifying 19 more devices belonging to categories such as gloves, syringes, orthopedic products, x-ray machines, etc. that only local manufacturers could bid on.
After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement.
As of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt
On Saturday, the Indian Ministry of Finance released a Notification (No. 28/2021–Customs) exempting the following medical devices from customs duties effective immediately until July 31st. The Notification comes as the Indian government continues to take additional steps to battle the ongoing COVID-19 emergency.
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