CDSCO Certification – Regulatory Approval for Drugs, Medical Devices & Cosmetics in India
Samridhi Compliance Certification provides complete consultancy for CDSCO Certification, required for manufacturing, importing, and selling drugs, medical devices, cosmetics, and diagnostics in India.
We help Indian and foreign companies navigate the complex approval process under the Central Drugs Standard Control Organization (CDSCO)—India’s national regulatory authority under the Ministry of Health and Family Welfare.
With our end-to-end support, your business can achieve faster market entry, stay legally compliant, and build trust in India’s healthcare and consumer market.
✅ What is CDSCO Certification?
The Central Drugs Standard Control Organization (CDSCO) is responsible for the regulation and licensing of:
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Drugs & Pharmaceuticals
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Medical Devices & Equipment
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In-Vitro Diagnostic Kits (IVDs)
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Cosmetics
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Blood & Blood Products
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Vaccines & Biologics
Any business involved in manufacture, import, clinical trials, or sale of these products must obtain the necessary approval or registration from CDSCO before launching in the Indian market.
🏥 Who Needs CDSCO Certification?
CDSCO approval is mandatory for:
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Indian Manufacturers of Medical Devices or Drugs
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Foreign Manufacturers Exporting to India
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Importers & Indian Authorized Agents (IAAs)
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Hospitals & Clinical Research Organizations (CROs)
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Cosmetic Product Manufacturers & Importers
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IVD Kit Developers & Distributors
🧾 CDSCO Categories Covered
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Medical Devices (Notified & Non-Notified)
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Class A, B, C, and D as per risk classification
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Includes syringes, stents, thermometers, BP monitors, implants, etc.
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Drugs & Pharmaceuticals
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Allopathic, biological, and traditional formulations
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Includes APIs, FDCs, vaccines, and new drugs
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Cosmetics
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Skin care, hair care, oral care, and fragrance products
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Importers must obtain cosmetic import registration
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IVDs (In-Vitro Diagnostics)
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Blood test kits, pregnancy test kits, rapid diagnostic devices
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Get Certified with Confidence – Your One-Stop Compliance Partner
From BIS, WPC, TEC, BEE, EPR, LMPC, CDSCO, FSSAI, ISO, MSME to PESO, NABL testing, Startup India, Make in India, and Lab Setup, we handle all your regulatory approvals, certifications, and documentation needs with precision and speed. Partner with Samridhi Compliance Certification and simplify your journey to full compliance—so you can focus on growing your business.
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