CDSCO vs ISP: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of CDSCO (India) vs ISP (Chile).
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
ISP
ISP — Chile Medical Device Regulatory Authority
Chile
ISP is the national regulatory authority responsible for medical device oversight in Chile. It manages device registration, market surveillance, and adverse event reporting within the Latin America re…
Class I, II, III, IV
ISP registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both CDSCO and ISP in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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