Slide Content of India Medical Device Regulation (Accolade)
1. Dear friends,
We, Accolade Consulting have compiled the slide sets entitled “Introduction to Medical Device
Regulations in 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, illustration comparisons)
Slide 3: Registration Format in ASEAN: Device & Drug
Slide 4: Sections of CSTD (Graphic)
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 Device Registrations
Slide 10: Medical Device Advisory Committee (MDAC)
Slide 11: In-Vitro Diagnostic Advisory Committee (IVDAC)
Slide 12: Glossary for India Device Regulation (Specific Terms such as Form 40, Form 10, etc.)
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 Approvals 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 Devices)
Slide 23: Drug Eluting Stent (DES)
Slide 24: Application 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: Import Tax and Duty for Medical Devices
Slide 33: Reference Source
Accolade Consulting International, Inc.