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CDSCO Import License for Medical Devices In India

All Medical Devices importing to India must comply with the Indian Medical Device Regulation set forth by the Central Drugs Standard Control Organisation (CDSCO). The CDSCO is responsible for the approval and regulation of all medical devices and Clinical Trials in the Country, laying down the standards for Drugs, medical devices control over the quality of imported medical devices, and coordination of the activity of State Drug Control Organizations.  

As per the new guidance of CDSCO, suspension and cancellation of import for Class A, B, C and D  medical devices may happen if importer fails to meet the deadline specified by CDSCO for mandatory Import license. CDSCO has set a complete procedure for granting licenses for medical devices imported in India. This procedure is applicable for all 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. Earlier manufacturers were able to sell their medical devices in India without following any specific rules and regulations but from 2006, medical devices entering India need to follow specific import guidelines set by CDSCO. 

In India, several companies import raw materials, semi-finished goods, or components. To market these as finished medical devices, obtaining a CDSCO manufacturing license is mandatory for the final assembly and packaging processes within India.

Regulations for CDSCO Import License for Medical Devices in India

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

Foreign manufacturers have to  appoint importer or authorized agents  in India to register  medical devices in India. The documents required for CDSCO import  license registration have been clearly specified in the amendments. The validity of CDSCO import license  will be 5 years from license issued. 

CDSCO Import License Registration Phases for Medical Devices

As per CDSCO rule there is a certain mandatory requirement of regulatory certificate from foreign manufacturers to register medical devices in India.

Phase I – Applicant Registration:

For applicant registration to CDSCO portal, client will have an active account on CDSCO online registration portal .An authorized agent/distributor (who must have wholesale drug license form 20/21B  or registration certificate form 41/42 to sell medical device in India) shall make an application for grant of  CDSCO import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a  CDSCO Import license. 

Procedure of Phase 1 
  • Online form submission. 
  • Submission of required document. 
  • Approval from CDSCO. 
  • If rejected, CDSCO will communicate the reason behind rejection or reapplication if necessary. 

Phase II – Medical Device Import License Application:

Import  license application  is required to have permission to import medical devices for commercial purposes.

Procedure of Phase 2 
  • Submission of online form with necessary details like classification of device, brand name, intended use, product description, etc. 
  • Uploading the documents as per Indian CDSCO regulatory norm like regulatory certificate European CE, freesale certificate, ISO 13485, Plant Master file, Device Master file etc. . 
  • CDSCO Fees to be paid as per product classification . 
  • Application number will be generated after successful submission of all documents along with fee challan copy.

Phase III – Review from CDSCO

  • CDSCO will review the application along with verification of all documents which are uploaded and if any query is observed they will communicate.
  • Submitting relevant justification or revised documents  to CDSCO online portal.

Phase IV– License Approval

CDSCO will review the justification along with verification of all documents and if it is as per CDSCO rule they will grant license.

How Deliberate Consulting Will Help You in CDSCO Import License Registration for Medical Devices?

Deliberate Consulting help manufacturers for obtaining various licenses required for importing and selling medical devices in India. These licenses include MD 14 license, MD 26 license, MD 42 license, and import license for medical devices.

Deliberate Consulting assists clients starting from right classification of medical devices, generation of CDSCO login credential, preparation of all technical documents, review and uploading of all technical documents and guidance for online CDSCO fee payment for successful application. 

Deliberate Consulting closely worked with CDSCO from the last 12 years and till date successfully completed 200 plus CDSCO registration. The Deliberate Consulting technical team has in-house capability to resolve CDSCO queries if any.