Medical Device Registration and approval in India
with CDSCO ( Form 41/Form 10)

The Central Drugs Standard Control Organization ( CDSCO) under Directorate General of Health services, Ministry of Health & Family welfare, Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located in FDA bhavan, Kotla Road, New Delhi 110002 and also has six zonal offices, four sub zonal offices, thirteen port offices and seven laboratories spread across the country.

The Drugs & Cosmetics Act 1940 and rules 1945 have entrusted various responsibilities to Central & state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of provisions of the Act & Rules made these under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

Under the Drugs and Cosmetics Act CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs control over the quality of imported drugs in the country and coordination of the activities of state drug Control Organization by providing expert advice with a view of brining about the uniformity in the enforcement of the Drugs and Cosmetics Act.

From 1st January 2018 a comprehensive set of rules called the "Medical Device Rules 2017" were specifically framed and implemented for medical devices & IVD’s under the drugs & Cosmetics Act & Rules to regulate the medical device industry with relevant and applicable regulations.

The Medical Devices Rule 2017 comprises of 12 chapters, 8 schedules and 40 Forms. It has been drafted to ensure is as comprehensive as possible within present day industry limitations and is designed to be flexible enough to add or delete the list of categorized products which are to be published from time to time by CDSCO.

Classification of medical devices and invitro diagnostics medical devices follow an internationally accepted, risk based approach. Based on the anticipated risk for the intended use, both, medical devices and in vitro diagnostics medical devices are classified either as;

  • Low Risk – Class A
  • Low Moderate Risk – Class B
  • Moderate High Risk – Class C and
  • High Risk Class D

The imported medical devices need to follow the registration process with CDSCO. Medical device registration certificate in Form 41 and import license in form 10 are required under the Drugs & Cosmetics Rules. Once the regulatory Design dossier is submitted by CDSCO the review will take place on the submitted documents and queries if any will take place on the submitted documents and queries if any will be sent to Authorized Indian agent for clarification and response. Following the successful addressing of the query letters, the registration certificate is issued which is valid for three year period.

Lexium consulting provides integrated end to end product categorization services, Medical device registration service as well as Indian Authorized agent services to all importers and manufacturers of medical devices & IVD’s our service offerings will help you import, manufacturer, test, conduct clinical trials and distribute your products in India ( Market authorization ) to accelerate your market entry through faster approvals.


call us today for your CDSCO registration