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Market Information
India’s healthcare expenditure stood at approximately 845 billion Indian rupees in 2022.
Market Trend: Health insurance schemes in 2021 extended coverage to about 514 million individuals across India, representing only 37% of the country's population.
India’s medical equipment market currently valued at $11 billion, is projected to reach $50 billion by 2025. This sector has exhibited consistent growth, maintaining a Compound Annual Growth Rate (CAGR) of 15% over the past three years.
The supervision of medical device registration in India is managed by the Central Drugs Standard Control Organization (CDSCO) within the Directorate General of Health Services, under the Ministry of Health & Family Welfare. CDSCO functions as India's National Regulatory Authority (NRA).
Medical Device Regulation
Central Drugs Standard Control Organization (CDSCO), under the MOHFW.
Classification, Fees, Timeline
DEVICE CLASS | FEES |
|---|---|
Class A | $1,050 |
Class B | $3,000 |
Class C | $4,500 |
Class D | $4,500 |
DEVICE CLASS | TIMELINE |
|---|---|
Classes A, B, C & D | 6 - 9 months |
Product Registration Routes
DEVICE CLASS | DESCRIPTION |
|---|---|
Class A | Low risk |
Class B | Low to moderate risk |
Class C | Moderate to high risk |
Class D | High risk |
Useful Information
Validity of License: 5 years.
License transfer: To extend the license, applicants need to provide updated documentation along with the prescribed fees for Device Master File(s) (DMF) and/or Plant Master File (PMF).
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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