• 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2021-10-27 05:22:18

A new expert committee has been formed by the Government, to frame new laws for medicines, cosmetics and medical devices in a bid to replace the existing Drugs and Cosmetics Act which was formed in 1940.

• 2021-10-27 03:54:29

More medical devices are being classified under India’s Medical Device Rule 2017 based on the intended use, risk associated with the device and other parameters. They include device categories ranging from nephrology and renal care, operation theatre, pain management, personal protective equipment (PPE), software, and general hospital medical devices.

• 2021-08-26 11:53:27

More medical devices are being classified under India’s Medical Device Rule 2017 based on the intended use, risk associated with the device, and other parameters. They include device categories ranging from interventional radiology, rehabilitation, dermatological and plastic surgery, physical support, anesthesiology, and in-vitro diagnostic (IVD) medical devices.

• 2021-06-25 12:28:19

As previously notified, the CDSCO has expanded the list of regulated medical devices in India, ranging from CT scan equipment, MRI equipment, defibrillators and more, in addition to all types of implantable devices

• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-03-16 06:50:01

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017. Medical Devices (Amendment) Rules, 2020 will be effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:48:29

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017, effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-02-21 07:19:49

CDSCO India has issued an extension for several types of medical devices to register for market authorization, some until January 2021 while the other types have until April 2021.