CDSCO Consultant in India
Medral Global is a leading CDSCO Consultant in India offering complete regulatory support for medical devices and in vitro diagnostic devices (IVDs). We specialize in helping manufacturers, importers, and distributors comply with the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017.
Our experienced team supports you throughout the entire regulatory journey — from preparing documentation and quality management systems to obtaining licenses and ensuring ongoing compliance. With Medral Global, you can bring your medical devices and IVDs to the Indian market smoothly and efficiently.
Our CDSCO Regulatory Services
- Medical Device and IVD Manufacturing License
If you plan to manufacture medical devices or IVDs in India, you must obtain a manufacturing license. Medral Global assists you with document preparation, QMS compliance, plant readiness, and coordination with the State Licensing Authority or CDSCO. We ensure your facility meets all regulatory requirements as per Form MD-5 and MD-6. - Medical Device and IVD Test License
For companies conducting clinical trials or performance evaluations, we help you obtain the CDSCO Test License (Form MD-12 and MD-13). This license allows controlled testing of medical devices and IVDs to meet safety and performance benchmarks. We manage dossier preparation, test protocols, and application submission. - Medical Device and IVD Import License
To import medical devices and IVDs into India, a CDSCO Import License (Form MD-14 and MD-15) is required. Medral Global provides end-to-end support in product classification, dossier preparation, CSDT formatting, and submission through the SUGAM portal. We ensure your imported products meet CDSCO requirements before entering the market. - Medical Device and IVD Loan License
A Loan License allows manufacturers to produce devices at a third-party facility without owning a plant. Medral Global supports the entire application process for this license (Form MD-4 and MD-6), helping you expand production cost-effectively while ensuring full compliance with CDSCO regulations. - Medical Device and IVD Wholesale and Retail License
If you are involved in distribution, whether as a wholesaler or retailer, a CDSCO license is mandatory. Medral Global assists in obtaining the necessary wholesale and retail licenses, ensuring that your distribution business operates within the legal framework of Indian regulations.
Why Choose Medral Global
- Pan India Support
Our consultants are located in Delhi, Mumbai, Gujarat, Kerala, Tamil Nadu, and other major regions to provide local expertise. - Regulatory Expertise
We have a deep understanding of the Medical Device Rules, 2017 and CDSCO processes. - Comprehensive Services
From documentation to license acquisition, we manage the entire compliance process for you. - Dedicated Consultation
Each client receives personalized service from a dedicated regulatory consultant.
Who Should Hire Medral Global
- Startups launching new medical devices in India
- Manufacturers expanding into the Indian market
- Importers looking to sell CE or FDA approved devices in India
- Companies conducting clinical trials or validation studies
- Businesses seeking contract manufacturing through loan licenses
- Distributors needing wholesale or retail CDSCO licenses
Based in Delhi, Serving Across India
Medral Global is headquartered in Delhi and operates throughout India. Whether you are applying for a manufacturing license in Gujarat, an import license in Maharashtra, or a wholesale license in Tamil Nadu, our team is ready to assist.
Partner with Medral Global
At Medral Global, we are committed to helping you achieve full CDSCO compliance. Our goal is to ensure that your medical devices and IVDs meet Indian standards and reach the market without delays. Trust our regulatory expertise and local experience to simplify your licensing process and help your business grow.