Medical Device Registration and CDSCO Approval in India
General country-specific regulatory information is provided on this page for medical device registration and approval in India. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including India, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in India
REGULATORY AUTHORITY: Central Drugs Standard Control Organization (CDSCO)
CLASSIFICATION SYSTEM: Medical Devices/IVDs: A/B/C/D.
TIMEFRAME: According to our experience, the new registration for Medical Devices/IVDs (all classes) will take around 8-10 months.
SPECIAL REQUIREMENT: CDSCO may visit the foreign manufacturer premises during the registration process to check the QMS compliance.
Local testing might be required if the authority has reasons to believe that the quality of the medical device is compromised.
Local clinical investigation might be required but, in many cases, foreign clinical data is accepted.
LOCAL FEES (New Application)
Class A: $1000 (one site); $50 (each distinct medical device)
Class B: $2000 (one site); $1000 (each distinct medical device)
Class C/D: $3000 (one site); $1500 (each distinct medical device)
In-vitro Diagnostics (IVDs)*
Class A/B: $1000 (one site); $10 (each distinct IVD)
Class C/D: $3000 (one site); $500 (each distinct IVD)
*Registration fee comprises two different type of payment component, one is representing the number of manufacturers, and another one is representing the number of products registered by the license holder from the same manufacturer.
LOCAL FEES (Manufacturer): No manufacturer registration is required, however, fee to conduct on-site inspection to overseas manufacturing site might be required.
LICENSE VALIDITY: The registration and importation certificates remain valid in perpetuity unless it is suspended or cancelled. However, retention fees shall be paid every 5 years from the certificate issuance date.
LICENSE TRANSFER: Technically, license transfer would not be necessary because multiple license holders is allowed. However, cancelling the current license holder and appointing new license holder is possible, but in this case new registration process will be required.
AUTHORIZED REPRESENTATIVE: A solely local authorized representative should be appointed by an overseas manufacturer through an official Letter of Authorization (LoA).
Last updated on May 27, 2021.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.