Diagnostic Registration in India
Accredited Consultants Pvt. Ltd., Simplifying Regulatory Approvals
In India, diagnostic kits, reagents, and in-vitro diagnostic (IVD) devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules (MDR), 2017. Companies must obtain the proper CDSCO registration and licensing to manufacture, import, or market diagnostics.
At ACPL, we provide complete support for diagnostic product registration. We help clients navigate the complex regulatory framework with ease, accuracy, and efficiency.
Our Services for Diagnostic Registration
– Classification of IVD Devices: Assistance in identifying risk categories (Class A, B, C, D)
– Import & Manufacturing License: Guidance for filing applications (MD-14, MD-15, MD-40, etc.)
– Test License Applications: For clinical performance evaluation and R&D
– Documentation & Dossier Preparation: Technical file, QMS compliance, ISO 13485 support
– Regulatory Submissions: Filing with CDSCO, coordination with Notified Bodies, and follow-ups
– Post-Market Compliance: Renewals, amendments, and vigilance reporting
Why Choose ACPL?
– 25+ years of experience in regulatory consulting
– Strong expertise in pharmaceuticals, medical devices, and diagnostics
– Proven success with Indian and global manufacturers and importers
– End-to-end compliance solutions from strategy to approval
Contact Us
Accredited Consultants Pvt. Ltd. (ACPL)
B-3, Sector-6, Noida – 201301, Uttar Pradesh, India
+91-9266665201 | +91-9310040434
acplgroupindia.co.in
