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Import License For Medical devices: Dueran Consultant is the leading regulatory consultant in India at an affordable cost.

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» Medical Device Import License in India Dueran Consultant

🢬 Dynamics of the Medical Devices in the Indian Market

🢬 Understanding Medical Device Regulation Framework in India

🢬 CDSCO Medical Device Classification

🢬 CDSCO: Regulatory Body for Medical Devices in India

🢬 Permission to manufacture/ Import Medical Device without predicate (Form MD26 and approval in Form MD27)

🢭 Can't be able to interpret the Indian regulatory framework for medical devices?

🢭 Classification

🢭 Quality Management System (QMS):

🢭 Import and Export

🢭 Clinical Investigations

🢭 Labeling and Packaging

🢭 PostMarket Surveillance

🢭 Class A (Low Risk):

🢭 Class B (LowtoModerate Risk):

🢭 Class C (ModeratetoHigh Risk)

🢭 Class D (High Risk):

🢭 Licensing and Registration Requirements for Medical Devices

🢭 Medical Device License: For Import

🢭 Importer Registration (Form MD14, Form MD15)

🢭 Test license to import Medical Devices (Form MD16, Form MD17)

🢭 Medical Device License: For Manufacturer

🢭 For Class A & B (Form MD3, Form MD5)

🢭 For Class C & D (Form MD7, Form MD9)

🢭 Voluntary Registration of Medical Devices

🢭 Permission to Manufacture or Permission for loan license to manufacture Class A & B Medical Devices in India

🢭 Permission to Manufacture or Permission for loan license to manufacture Class C & D Medical Devices in India

🢭 Permission For Test License to manufacture Medical Device

🢭 Personal Use License: (Form MD20 and Form MD21)

🢭 Application for Clinical Investigation: (Form MD22 and Form MD23)

🢭 Free Sale Certificate

🢭 Market Standing Certificate:

🢭 NonConviction Certificate:

🢭 Neutral Code Certificate:

🢭 Registration of Class A Medical Devices which are Non Sterile, and Nonmeasuring Devices

🢭 Quick Links

🢭 Official Info

› Miscellaneous Services: