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