Please clarify us for the new cdsco notification passed on 01.01.2024 for MD-12/16. What about those applications which was submitted previously and already in process since 2 months?
You can watch our video ua-cam.com/video/9BsQ0zBGhfo/v-deo.htmlsi=OHVNvZAbWvb8RBuQ STATE LICENSE FLOW CHART ( Class A & B Products) • Online registration of company on the Portal of CDSCO ( 1 days) • Online acknowledgement of registration by CDSCO • Physical submission of registration documents at CDSCO Headquarter Delhi • Issuance of user id, password by CDSCO for further process. (15 days) • Filing online application for test license at CDSCO portal • Online Grant of test license on Form MD-13 by CDSO Headquarter Delhi.(30 days) • Purchase of small quantity of Raw Material & Packing Material required to make Pilot Batches. • Preparation of Pilot Batches by company for testing ( 45 days) • Biocompatibility & Stability Testing done by NABL ( 225 days) • Online application for grant of Manufacturing License & Product Permission on CDSCO Portal. ( 120 days) • Review of application online by State FDA ( 135 days) • Assignment of Notified Inspection Body by State FDA ( 140 days) • Submission of quotation for inspection by Inspection body ( 145 days) • Payment done by company to Notified Inspection Body ( 147 days) • Audit conducted by Notified Body ( 160 days) • Query raised by Notified Inspection Body • Compliance done by company ( 175 days) • Compliance letter sent to State FDA by Notified Body ( 185 days) • License & Product Permission Granted online by State FDA( 200 days)
Please clarify us for the new cdsco notification passed on 01.01.2024 for MD-12/16. What about those applications which was submitted previously and already in process since 2 months?
They will continue to process
Hi , Can you guide on license requirement for Class B , especially metered dosage pens without needle and cartridge?
You can watch our video ua-cam.com/video/9BsQ0zBGhfo/v-deo.htmlsi=OHVNvZAbWvb8RBuQ STATE LICENSE FLOW CHART ( Class A & B Products)
• Online registration of company on the Portal of CDSCO ( 1 days)
• Online acknowledgement of registration by CDSCO
• Physical submission of registration documents at CDSCO Headquarter Delhi
• Issuance of user id, password by CDSCO for further process. (15 days)
• Filing online application for test license at CDSCO portal
• Online Grant of test license on Form MD-13 by CDSO Headquarter Delhi.(30 days)
• Purchase of small quantity of Raw Material & Packing Material required to make Pilot Batches.
• Preparation of Pilot Batches by company for testing ( 45 days)
• Biocompatibility & Stability Testing done by NABL ( 225 days)
• Online application for grant of Manufacturing License & Product Permission on CDSCO Portal. ( 120 days)
• Review of application online by State FDA ( 135 days)
• Assignment of Notified Inspection Body by State FDA ( 140 days)
• Submission of quotation for inspection by Inspection body ( 145 days)
• Payment done by company to Notified Inspection Body ( 147 days)
• Audit conducted by Notified Body ( 160 days)
• Query raised by Notified Inspection Body
• Compliance done by company ( 175 days)
• Compliance letter sent to State FDA by Notified Body ( 185 days)
• License & Product Permission Granted online by State FDA( 200 days)
Please can you clarify about loan license. how to apply in Sugam portal under in registration purpose. For manufacture of medical devices?
You need to apply on cdscomdonline.gov.in
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