Swissmedic vs CDSCO: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs CDSCO (India).
Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device…
Class I, IIa, IIb, III
EU CE recognition / Swiss conformity assessment
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
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
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