§ COMPARE REGULATORS

CDSCO vs Medsafe: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of CDSCO (India) vs Medsafe (New Zealand).

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

CLASSES

Class A, B, C, D

PATHWAY

CDSCO registration / import license

KEY FUNCTIONS
  • Medical device registration
  • Import license (Form MD-14)
  • Clinical investigation approval
  • Quality management system audit
  • Adverse event reporting

Medsafe

Medsafe — New Zealand Medical Device Regulatory Authority

New Zealand

Medsafe is the national regulatory authority responsible for medical device oversight in New Zealand. It manages device registration, market surveillance, and adverse event reporting within the Asia-P

CLASSES

Class I, IIa, IIb, III

PATHWAY

Medsafe registration

KEY FUNCTIONS
  • Device registration
  • Market surveillance
  • Adverse event reporting
  • Import/export control

MedFlux monitors both CDSCO and Medsafe in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.

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