Tracc Global is a trusted regulatory consulting company helping manufacturers, importers, and authorized representatives obtain a CDSCO Import Licence for medical devices in India. Our experienced regulatory experts provide end-to-end support for the complete licensing process, including document preparation, application filing, regulatory strategy, compliance review, and coordination with CDSCO.

We assist businesses with MD-14 and MD-15 applications, product classification, technical documentation, Free Sale Certificate review, ISO 13485 compliance guidance, and post-approval regulatory support. Whether you are importing diagnostic devices, surgical equipment, implants, or in-vitro diagnostic (IVD) products, our team helps streamline the approval process while ensuring compliance with the Medical Devices Rules, 2017.

With extensive experience in global medical device regulations, Tracc Global delivers accurate, transparent, and timely regulatory solutions that help companies reduce delays and bring compliant medical devices to the Indian market faster.

Our Services

CDSCO Import Licence (MD-14 & MD-15)
Medical Device Registration
Regulatory Documentation Support
Product Classification
Technical File Review
ISO 13485 & Regulatory Compliance
Global Medical Device Regulatory Consulting

Why Choose Tracc Global?

Experienced medical device regulatory specialists
End-to-end CDSCO compliance support
Faster documentation and submission process
Personalized guidance for domestic and international manufacturers
Reliable regulatory solutions tailored to your business

Get Started Today
Looking to obtain a CDSCO Import Licence for your medical devices? Partner with Tracc Global for expert regulatory guidance and a hassle-free licensing process.

Contact Tracc Global today to discuss your requirements and receive professional support for your CDSCO Import Licence application.