Complete Guide to CDSCO Approvals
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
Medical Device Parks in India
Government of India Medical Device Parks Scheme explained clearly
Incentives, infrastructure & financial support for manufacturers
Locations of approved medical device parks across India
Application & approval process simplified step-by-step
Infrastructure facilities, labs, R&D & common services covered
Comparison with global medical device parks
Practical guidance for startups, manufacturers & investors
For MedTech companies, entrepreneurs, policymakers & consultants
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
UAE Market Access Guide For Global Medical Device Companies
A comprehensive handbook covering UAE & Arab medical device market entry, regulatory approvals, business setup, and compliance—explained step-by-step.
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End-to-end UAE medical device market access roadmap
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MoHAP medical device registration & lifecycle compliance
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Company registration, licensing & free zone setup in UAE
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Import–export, customs & distribution compliance
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GCC regulatory comparison & real-world case studies
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Designed for global manufacturers, MedTech startups & regulatory teams