CDSCO
印度中央藥品標準控制組織
India
Last reviewed 2026-06-21
CDSCO根據2017年《醫療器材規則》（2020年修訂）監管印度醫療器材。印度使用四級分類（A、B、C、D）。印度是全球增長最快的主要醫療器材市場。
器材分類
Class A, B, C, D
審批路徑
CDSCO registration / import license
核心監管職能
- ▸醫療器材註冊
- ▸進口許可證（MD-14表）
- ▸臨床調查審批
- ▸品質管理體系審核
- ▸不良事件報告
§ 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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