Qualtech Webinar: ENTERING INDIA'S MEDTECH MARKET — MEDTECH INDUSTRY OVERVIEW AND REGULATORY ROADMAP IN INDIA
- 2024-10-08 05:56:39
Join Qualtech's Webinar on India's Medical Device Market and Regulations
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MoreA 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.
MoreMore 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.
MoreMore 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.
MoreAs 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
MoreCDSCO 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.
MoreMedical 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”.
MoreMedical 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”.
MoreCDSCO 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.
MoreEight notified bodies have now been registered with the CDSCO intends to carry out audit of a manufacturing site of Class A or Class B of medical devices.
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