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Oskar Wang
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Dear friends, We, Accolade Consulting have complied the slide sets entitled “ Introduction to Medical Device Regulations (India)” with the content (of each presentation slide with its heading) as follows: Slide 0: Slide Cover Page Slide 1: Disclaimer Slide 2: Concept Difference in Device Approval (US/EU vs. China) Slide 3: Registration Format in ASEAN: Device & Drug Slide 4: Sections of CSTD Slide 5: Key Health Authority in India Slide 6: Organogram of Device Division at CDSCO Slide 7: Source of Laws/ Regulations Governing Device (India) Slide 8: Regulation Snapshot of Medical Device in India Slide 9: Points to be Noted for India Registration Slide 10: Medical Device Advisory Committee (MDAC) Slide 11: In-Vitro Diagnostic Advisory Committee (IVDAC) Slide 12: Glossary for India Device Regulation Slide 13: Medical Device Classification Slide 14: Pre-Clinical Product Testing Slide 15: Clinical Trial Requirement –Imported Device Slide 16: Official Registration Fees- Import Device Slide 17: Pharmacovigilance & Product Recalls Slide 18: Reference Approval in Key Markets Slide 19: Flow Chart for Import Device Approval (India) Slide 20: Timeline to Get Device Approval (Import) Slide 21: Medical Device Part Slide 22: Categories requiring Full Registration (* Regulated as Drug, Else as Notified Device) Slide 23: Drug Eluting Stent (DES) Slide 24: Applications Dossiers for Full Registration Slide 25: Others- Registration for Import License Slide 26: Diagnostic Kits/ Reagent Part Slide 27: Diagnostic Kits/ Reagent Need Full Registration Slide 28: Other IVD: Filings for Import License Only Slide 29: Non- Compliance in Submission- Covering Letter Slide 30: Non- Compliance in Submission Examples- Form 40 Slide 31: Non- Compliance in Submission- T.R.- 6 (Challan) Slide 32: Reference Source Accolade Consulting International, Inc./ Oskar Wang

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Slide content of india medical device regulation (accolade)

  • 1. Dear friends, We, Accolade Consulting have complied the slide sets entitled “ Introduction to Medical Device Regulations (India)” with the content (of each presentation slide with its heading) as follows: Slide 0: Slide Cover Page Slide 1: Disclaimer Slide 2: Concept Difference in Device Approval (US/EU vs. China) Slide 3: Registration Format in ASEAN: Device & Drug Slide 4: Sections of CSTD Slide 5: Key Health Authority in India Slide 6: Organogram of Device Division at CDSCO Slide 7: Source of Laws/ Regulations Governing Device (India) Slide 8: Regulation Snapshot of Medical Device in India Slide 9: Points to be Noted for India Registration Slide 10: Medical Device Advisory Committee (MDAC) Slide 11: In-Vitro Diagnostic Advisory Committee (IVDAC) Slide 12: Glossary for India Device Regulation Slide 13: Medical Device Classification Slide 14: Pre-Clinical Product Testing Slide 15: Clinical Trial Requirement –Imported Device Slide 16: Official Registration Fees- Import Device Slide 17: Pharmacovigilance & Product Recalls Slide 18: Reference Approval in Key Markets Slide 19: Flow Chart for Import Device Approval (India) Slide 20: Timeline to Get Device Approval (Import) Slide 21: Medical Device Part Slide 22: Categories requiring Full Registration (* Regulated as Drug, Else as Notified Device) Slide 23: Drug Eluting Stent (DES) Slide 24: Applications Dossiers for Full Registration Slide 25: Others- Registration for Import License Slide 26: Diagnostic Kits/ Reagent Part Slide 27: Diagnostic Kits/ Reagent Need Full Registration Slide 28: Other IVD: Filings for Import License Only Slide 29: Non- Compliance in Submission- Covering Letter Slide 30: Non- Compliance in Submission Examples- Form 40 Slide 31: Non- Compliance in Submission- T.R.- 6 (Challan) Slide 32: Reference Source Accolade Consulting International, Inc./ Oskar Wang