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市场信息
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.
分类、费用、时间表
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 |
产品注册途径
DEVICE CLASS | DESCRIPTION |
|---|---|
Class A | Low risk |
Class B | Low to moderate risk |
Class C | Moderate to high risk |
Class D | High risk |
有用信息
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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