Complete Guide to CDSCO Approvals
Complete Guide to CDSCO Approvals in India
Drugs, Cosmetics & Medical Device registrations explained step-by-step
Covers CDSCO licensing, digital portals & compliance procedures
Drug import, manufacturing & test licenses simplified
Medical Devices approvals under MDR 2017 (Class A–D)
Cosmetics import & manufacturing registrations covered
Includes CDSCO & State FDA directory
For pharma, MedTech professionals, startups & regulatory teams
Guide on Medical Device Certifications
India Entry Guide For Global Medical Device Companies
- Global medical device companies ke liye India market entry ka complete guide
- MDR 2017 & CDSCO licensing explained – import & manufacturing pathways
- Business setup, FDI, IP protection & legal structures in India
- BIS, labeling, WPC, NPPA, AERB & environmental compliance overview
- Distribution, tenders & localization strategies for India
- Post-market obligations & lifecycle management basics
- For foreign manufacturers, regulatory teams & market access professionals
Launch of Innovative Medical Device in India
Make in India for Medical Devices
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MDR 2017 (Medical Devices Rules) ka simple guide
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Device Classification: Class A–D (easy explanation)
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Key Licenses: MD-5, MD-9, MD-15, MD-42
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PMF & DMF plant/documentation basics
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ISO 13485 QMS, testing (BIS/NABL/ISO), labeling/UDI
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Assembly vs True Manufacturing + PLI & Device Parks overview
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For manufacturers, startups, investors & compliance teams
Software as a Medical Device
- SaMD (Software as a Medical Device) ke liye India ka complete regulatory guide (MDR 2017)
- SaMD vs SiMD + intended use ke basis par applicability clear
- Classification (Class A–D) for software with India-focused examples
- Licensing pathway: Manufacturing (MD-5/MD-9), Import (MD-14/MD-15), Loan (MD-6/MD-10), Test (MD-12/MD-13)
- Essential Principles + Conformity Assessment (ISO 13485, IEC 62304, ISO 14971)
- Clinical evidence & performance evaluation requirements simplified
- Legal compliance: liability, recall, privacy, cybersecurity, DPDP Act 2023
- Post-market obligations: PMS, adverse event reporting, recall rules
- For manufacturers, software developers, importers & regulatory teams