Does a Medical Device Require Registration in India?
Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), which is part of the Department of Health and Family Care. Only a limited number of medical devices and IVDs require registration in India. Medical devices submitted under the new voluntary rules are referred to as “non-regulatory medical devices.” For the marketing of imported medical devices in India, the registration certificate for medical devices in Form 41 and the Import License in Form 10 is required in accordance with the rules for medicines and cosmetics.
The CDSCO has designated 21 device types as ‘Notified Devices’ for the registration of medical devices in India.
However, there are more than 21 devices that require registration. Morulaa’s regulatory experts can help you determine whether your items need to be registered as medical devices in India. Medical gadgets that need to be charged
Spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes, and needles are all registered in India.
Endotracheal tubes, catheters, dental implants, surgical sealants, heart valves, cardiac stents, orthopaedic implants, endotracheal tubes, as well as others.
Medical devices require registration in India
After submitting complete and accurate documents and payments to get the registration certificate, the time it takes to register medical devices in India is usually 6-9 months. The registration is valid for three years, and renewal applications must be received six months before the registration expires.
Because of its reliance on imports, manufacturers are drawn to the Indian market. However, the Regulatory Body in India is still in its infancy, and regulations may be amended in short periods of time, causing uncertainty in the approval process. Keeping an eye on our daily news could be a smart idea.
This blog does not provide medical advice. It is intended for informational purposes only. Do not use it as a
substitute for professional medical advice, diagnosis, treatment, or disease prevention. Always seek the
advice of your physician or qualified healthcare providers for any questions you have regarding a medical
condition.
The views and opinions expressed on this blog are solely those of the original authors and other
contributors. These views and opinions do not necessarily represent those of Gabriel Nieves, LAC
Healthcare Solutions, LAC.us Staff, and/or any/all contributors to this blog/site.
medical devices require registration in India
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