CDSCO Import License Consultant for Medical Devices

Overview of CDSCO Import License for Medical Devices In India
Whenever you import medical devices in India you must follow all compliance rules for medical devices which are set forth by the CDSCO. The CDSCO department is only responsible for the approval and regulation of all medical devices and clinical trials in the country, laying down the standards for Drugs, and medical devices controlling the quality of imported medical devices, and coordinating of the activity of State Drug Control Organizations.

According to the new guidelines of the CDSCO Department, suspension and cancellation of CDSCO import license for medical devices for classes A, B, C, and D. It’s may happen if the importer of medical devices fails to fulfill the deadlines which are specified by CDSCO for a mandatory import license.

The CDSCO Department has already set a complete process for granting CDSCO import licenses for medical devices in India. This process applies to all types of medical device importers/distributors who import medical devices from other countries to India. However, all medical devices need to be classified according to the CDSCO classification rule. Some time ago medical device importers were able to sell out their devices in India without following any mandatory rules and regulations. But from 2006 onwards medical devices were banned from entering India if you do not follow specific import license guidelines which is set by CDSCO.

In India, there are several companies who’s import raw materials, semi-finished products, or other types of components. To market these as a finished medical device, getting a CDSCO manufacturing license is mandatory for the final assembly and packaging processes in India.

CDSCO Import License Registration for Medical Devices
Pre-requisites for registration process:
Generic Name / Brand Name
Intended Use
Material of construction
Mode of application
Study of device details and Classification of medical devices on the basis of risk of product.