India's Leading CDSCO Registration Experts
Specialized CDSCO Certification Consulting to Ensure Smooth Approval Without Delays.
Everything You Need to Know About CDSCO Registration
India's Central Drugs Standard Control Organisation (CDSCO) regulates medical devices, drugs, diagnostics, and cosmetics. Here's a complete overview of the approval process, product categories, and key compliance requirements.
Medical Devices
All medical devices sold in India require CDSCO registration under MDR 2017.
Drugs & Pharmaceuticals
New drug approvals, clinical trial NOC, and manufacturing licences under Drugs Act.
Cosmetics
Cosmetics imported into India need a CDSCO Cosmetic Registration Certificate (CRC).
In-Vitro Diagnostics
IVD products are regulated under MDR 2017 and require mandatory CDSCO approval.
CDSCO Registration Process — Step by Step
Document Preparation
Technical files, clinical data, manufacturing details, and labelling as per CDSCO norms.
Application Filing
Submit on SUGAM portal with correct form — MD-14/15, MD-3/5, MD-7/9 etc.
CDSCO Review
Central Licensing Authority reviews dossier; queries raised are answered promptly.
Testing & Evaluation
Product tested at NABL / CDSCO-approved labs; clinical evaluation if required.
License Granted
Import / Manufacturing license issued. Valid 3–5 years; renewable before expiry.
Explore Our Services and Mission
Our Core Service Offerings
- CDSCO Registration & Product Certification Solutions
- Product Registration & Regulatory Compliance Services
- Technical Support & Quality Assurance Solutions
Driving Excellence in Compliance
Key Milestones & Achievements:
- Established as a Top CDSCO Registration Consultant dedicated to simplifying complex compliance procedures.
- Expanded our services to include CDSCO Registration Approvals for both domestic and foreign clients.
- Built a network of testing partners and regulatory experts across India, helping 1000+ brands achieve certification faster.
- Recognized as one of India's leading compliance firms, ensuring every product meets CDSCO Registration quality standards.
- Committed to client-first excellence, offering 24/7 support, transparent documentation, and end-to-end project management.
Our Mission – Empowering Manufacturers
Mission Statement:
Empowering Manufacturers with Trusted CDSCO Certification & Compliance Solutions
Commitments:
- Founded to Simplify CDSCO Compliance: In 2012, EVTL India was established with the mission to empower manufacturers, importers, and global brands in meeting CDSCO Certification and Indian Standard Compliance requirements.
- Partnering with Recognized Testing Laboratories: We collaborate with CDSCO-approved and NABL-accredited testing labs, providing seamless product testing, evaluation, and documentation support.
- Specializing in All CDSCO Certification Schemes: We are experts in CDSCO Registration, delivering compliance solutions that meet the latest CDSCO regulations for both domestic and foreign manufacturers.
- Committed to Quality, Accuracy & Transparency: At EVTL India, we follow a zero-compromise policy on quality, ensuring every certification process is accurate, fast, and fully compliant with CDSCO norms.
- 24/7 Client Support with Dedicated Expertise: Our experienced consultants are available round-the-clock for application filing, audit preparation, and license renewal.
Driving India's Growth in Quality & Global Standards — With integrity, innovation, and dedication, EVTL India continues to support India's vision for quality healthcare and global product standardization through reliable CDSCO certification consultancy.
Trusted By Industry Leaders
What Our Clients Say
"EVTL India streamlined our entire CDSCO Medical Device Registration process. Their documentation and regulatory expertise ensured quick approval without delays."
"Importing medical devices into India seemed complex, but EVTL handled our MD-14 and MD-15 licensing smoothly with complete transparency."
"We required urgent CDSCO drug approval for a new product launch. EVTL's professional guidance helped us secure permission faster than expected."
"Their in-depth knowledge of CDSCO regulations and proactive compliance support made our cosmetic import registration completely hassle-free."
Ranjan Singh
Dedicated Consultant
Your Go-To Expert:
Seamless compliance, guaranteed.
Get In Touch With Our CDSCO Experts
Submit your details and our CDSCO specialists will reach out with personalized guidance tailored to your registration needs.
Explore Our Comprehensive CDSCO Certification Services
Frequently Asked Questions
Who needs CDSCO registration in India?
Any manufacturer, importer, or distributor of medical devices, drugs, diagnostics, or cosmetics entering the Indian market must obtain CDSCO approval under the Drugs and Cosmetics Act and MDR 2017.
What is the difference between MD-14 and MD-15?
MD-14 is the Import Licence for Class A & B medical devices (low–moderate risk). MD-15 is the Import Licence for Class C & D medical devices (high risk), which require more detailed clinical documentation.
How long does CDSCO registration take?
Timelines vary: Class A/B import licence typically 3–6 months; Class C/D can take 6–18 months. Proactive documentation and query resolution with EVTL India significantly reduces delays.
Is ISO 13485 mandatory for CDSCO?
Foreign manufacturers exporting medical devices to India must hold a valid ISO 13485 or equivalent QMS certificate. Domestic manufacturers must comply with Schedule M of the Drugs Rules.
CDSCO Services We Cover
Need expert CDSCO guidance?
Our team has helped 1000+ brands navigate CDSCO approvals — domestic and foreign.