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India
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).
医疗器械法规
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
许可证的有效期：5年。
许可证转让：为了延长许可证，申请人需要提供更新的文件以及设备主文件（DMF）和/或工厂主文件（PMF）的规定费用。
进口商和分销商：本地持证人代表产品所有者负责指定进口商和分销商。
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