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Cambodia
市场信息
Cambodia’s healthcare expenditure accounted for 485 million USD in 2019.
Market Trend: 30% of the population benefits from health insurance.
Cambodia’s medical equipment market is anticipated to witness a steady annual growth rate of 8.40% from 2023 to 2028 (CAGR 2023-2028), resulting in a market volume of US$128,800.00k by 2028.
In Cambodia, the oversight of medical devices falls under the jurisdiction of the Department of Drugs and Food (DDF) operating within the Ministry of Health. The primary regulatory framework governing medical devices is outlined in Prakas No. 1258, dated November 8, 2012, which details the procedures for the registration of medical devices, henceforth referred to as 'Prakas 1258'.
分类、费用、时间表
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Classes A, B, C and D | 400,000 KHR | 12 - 18 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
许可证有效期：3年。
许可证转让：需要重新注册。
进口商和分销商：本地许可证持有者代表产品所有者负责指定进口商和分销商。
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