Medical Device Registration and Approval 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):

Medical Devices*

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).

 

ADDITIONAL INFORMATION:

• According to a Circular released on September 2022 the transition timeline for class A & B non-notified devices to become notified devices and hence requiring full product registration has been extended until March 2023.
• Starting October 2023, class C & D non-notified devices will become notified devicesand hence will require full product registration.
• As of June 30, 2022, the following devices are considered as drugsbut will still follow the registration under notified devices: implantable medical devices, CT scan, MRI, defibrillator, PET, dialysis, x-ray & bone marrow cell separator.
• According to an order release in September 2021, medical devices pertaining to software are considered as non-notified devices.

Other Central & East Asia Countries:  Afghanistan, China, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Taiwan, Tajikistan, Uzbekistan,Pakistan