CDSCO
印度中央药品标准控制组织
India
Last reviewed 2026-06-21
CDSCO根据2017年《医疗器械规则》（2020年修订）监管印度医疗器械。印度使用四级分类（A、B、C、D）。印度是全球增长最快的主要医疗器械市场。
器械分类
Class A, B, C, D
审批路径
CDSCO registration / import license
核心监管职能
- ▸医疗器械注册
- ▸进口许可证（MD-14表）
- ▸临床调查审批
- ▸质量管理体系审核
- ▸不良事件报告
§ FAQ
What is CDSCO in India?
CDSCO (Central Drugs Standard Control Organization) is India's national regulatory authority for medical devices, operating under the Ministry of Health & Family Welfare. It regulates devices under the Medical Devices Rules 2017 (amended 2020) using a four-class system (A, B, C, D). India is the fastest-growing major medical device market globally.
How do I register medical devices in India with CDSCO?
Medical device registration in India requires: an import license (Form MD-14) for foreign-manufactured devices, appointment of an Authorized Indian Agent, submission of technical documentation including performance and safety data, and a manufacturing site audit for Class C and D devices. Class A and B devices follow a simplified registration path.
What are CDSCO device classification classes?
India uses a four-class risk-based system: Class A (lowest risk, e.g. tongue depressors), Class B (low-moderate risk, e.g. hypodermic needles), Class C (moderate-high risk, e.g. hemodialysis equipment), and Class D (highest risk, e.g. heart valves, implantable defibrillators). Classification follows the Medical Devices Rules 2017 schedule and is broadly aligned with GHTF/IMDRF recommendations.
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