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 Initial Application Fees for General Medical Devices (Non‑IVD, USD, for Overseas Manufacturers)
- Class A (excluding non‑sterile, non‑measuring devices): $1,000 per manufacturing site + $50 per individual product
- Class B: $2,000 per manufacturing site + $1,000 per individual product
- Class C: $3,000 per manufacturing site + $1,500 per individual product
- Class D: $3,000 per manufacturing site + $1,500 per individual product
Import License Initial Application Fees for In‑vitro Diagnostic (IVD) Devices (USD, for Overseas Manufacturers)
- Class A/B IVD: $1,000 per manufacturing site + $10 per individual reagent product
- Class C/D IVD: $3,000 per manufacturing site + $500 per individual reagent product
5‑Year Retention & Renewal Fees for Import License (USD, payable every 5 years)
① General Medical Devices (Non‑IVD): Site retention fee only, no additional per‑product surcharge
- Class A site: $1,000
- Class B site: $2,000
- Class C/D site: $3,000
② IVD Medical Devices Retention Fee (site fee + per‑product surcharge applies)
- Class A/B IVD: $1,000 per manufacturing site + $10 per individual product
- Class C/D IVD: $3,000 per manufacturing site + $500 per individual product
Overseas Manufacturing Site On‑site Inspection Fee
Single on‑site audit of overseas manufacturing plant: $6,000
Clinical‑related Application Fees (Indian Rupee, INR)
- Pilot Clinical Trial License: 100,000 INR per project
- Pivotal Clinical Trial License: 100,000 INR per project
- IVD Clinical Performance Evaluation Application: 25,000 INR per project
