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§ ASIA-PACIFIC
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 globally, with increasing regulatory sophistication and domestic manufacturing emphasis.
DEVICE CLASSES
Class A, B, C, D
APPROVAL PATHWAY
CDSCO registration / import license
KEY REGULATORY FUNCTIONS
- ▸Medical device registration
- ▸Import license (Form MD-14)
- ▸Clinical investigation approval
- ▸Quality management system audit
- ▸Adverse event reporting
OFFICIAL WEBSITE
https://cdsco.gov.in →MedFlux monitors CDSCO regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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