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CDSCO Import License Consultant for Medical Devices

Mar 30th, 2024 at 16:32   Services   Pune   18 views Reference: 58170

Location: Pune

Price: Contact us


CDSCO Import license for medical devices are issued under the Directorate General of Health Services in the Ministry of Health and Family Welfare.

If you want to accelerate your CDSCO Import licensing process then you can contact the Indiaxis team. Indiaxis team is a leading CDSCO Import license consultant in India. The team of Indiaxis company will assist you at every stage to get a medical device import license from CDSCO.

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.

Latest CDSCO Update

In collaboration with TCS and Invest India, India’s Directorate General of Health Services has started the National Single Windows System (NSWS) Portal, to simplify and streamline the CDSCO import license for media devices approval process. This process is effective from 1st January 2024, stakeholders are advised to transition to this user-friendly portal, available at https://www.nsws.gov.in, as the existing CDSCO md online platform will be deactivated by January 15, 2024.

Ordinance for CDSCO Import License for Medical Devices in India

CDSCO Import License for medical devices is an ordinance in India that any industry or individual who has the license (wholesale Form 20/21 B and/or registration certificate to sell any medical device in India form 41/ 42 can apply for a CDSCO import license under Central Drugs and cosmetics act, 1940 and can import any medical devices into India.

To register medical devices in India Foreign manufacturers have to appoint importers or authorized agents in India. In amendments clearly specified which documents are required for CDSCO Import License registration. The validity of the CDSCO Import License is 5 years from the date of the license issued.