NMPA vs CDSCO: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of NMPA (China) vs CDSCO (India).
NMPA
National Medical Products Administration (China)
China
China's NMPA regulates medical devices through CMDE (Center for Medical Device Evaluation) technical reviews. China uses a three-class risk-based system. Foreign manufacturers must appoint a Marketing…
Class I, II, III
NMPA Registration (CMDE review)
- ▸CMDE technical review
- ▸MAH (Marketing Authorization Holder) system
- ▸In-country testing requirements
- ▸Clinical trial oversight
- ▸NMPA registration certificates
CDSCO
Central Drugs Standard Control Organization (India)
India
India's CDSCO regulates medical devices under the Medical Devices Rules 2017 (amended 2020). India uses a four-class system (A, B, C, D). India is the fastest-growing major medical device market globa…
Class A, B, C, D
CDSCO registration / import license
- ▸Medical device registration
- ▸Import license (Form MD-14)
- ▸Clinical investigation approval
- ▸Quality management system audit
- ▸Adverse event reporting
MedFlux monitors both NMPA and CDSCO in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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