Multi Market Strategy

Official sources: IMDRF; CDSCO; RAPath AU; RAPath EU; RAPath US

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Multi-Market Strategy for India (CDSCO)

Companies seeking to market devices in India should consider:

• Classification under IMDRF-aligned system (Class A–D)
• Import licence requirements via Form MD-14/15
• Dossier submission in English
• GMP certification or WHO-listed country equivalency
• Regulatory timeline: 90–180 days for standard approval
• Post-market surveillance and adverse event reporting obligations

See India vs TGA, CE, FDA for comparative timelines and requirements.