Indian Regulatory Authorities
The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services of the Ministry of Health and Family Welfare, serves as India’s National Regulatory Authority (NRA) for medical devices. It is responsible for the registration, approval, and regulation of imported medical devices, with the Central Licensing Authority (CLA) within the CDSCO responsible for reviewing applications and issuing licenses.
The Drug Controller General of India (DCGI), within CDSCO, is the body responsible for formulating national medical device policies. CDSCO regulates medical devices and in vitro diagnostic devices in accordance with the Medical Devices Rules, 2017, which are based on the Drugs and Cosmetics Act, 1940.
Regulatory Authority Website:https://cdsco.gov.in/opencms/opencms/en/Home/
Regulatory Framework
The Medical Device Rules, 2017
Risk Classification
The risk classification criteria for medical devices are specified in Part I of Schedule I of the MDR-2017. The risk classes are as follows:
- Class A - Low risk;
- Class B - Medium-low risk;
- Class C - Medium-high risk;
- Class D - High risk;
The risk classification parameters for in vitro diagnostic medical devices are specified in Part II of Schedule I of the MDR-2017, with the following risk levels:
- Class A - Low risk;
- Class B - Medium-low risk;
- Class C - Medium-high risk;
- Class D - High risk;
Prerequisites for Market Access / Basis for Registration
CDSCO requires a Certificate of Free Sale from both the country of origin and the reference country, as well as ISO 13485 certification.
Licensee Requirements
CDSCO explicitly stipulates that foreign manufacturers (non-Indian entities) cannot submit registration applications directly; they must proceed through an “Authorized Indian Representative (AIR),” who serves as the sole point of contact between the foreign manufacturer and Indian regulatory authorities.
Registration Language
English
Registration Process, Timeline, and Official Fees
The timeline for granting an “Import License” is 6–9 months (from the date of application), provided that the documentation is complete and compliant. If the application is rejected, the competent authority will provide a written statement of reasons.
Import License application fees for medical devices are as follows:
- Class A (excluding non-sterile and non-measuring devices): $1,000 per manufacturing site + $50 per product
- Class B: $2,000 per manufacturing site + $1,000 per product
- Class C: $3,000 per manufacturing site + $1,500 per product
- Class D: $3,000 per manufacturing site + $1,500 per product
Import License Maintenance Fees (payable every 5 years) apply to in vitro diagnostic medical devices (IVD):
- Class A (excluding non-sterile and non-measuring devices): $1,000 per manufacturing site + $10 per product
- Class B: $1,000 per manufacturing site + $10 per product
- Class C: $3,000 per manufacturing site + $500 per product
- Class D: $3,000 per manufacturing site + $500 per product
On-site inspection fee: $6,000
Clinical trial application fees
- Pilot Clinical: 100,000 INR / Project
- Pivotal Clinical: 100,000 INR / Project
Clinical Performance Evaluation Application Fee: 25,000 INR / Project
