Medical Device Registration
Comprehensive support for manufacturers, importers and distributors.
- MD-14 Import Licence
- MD-5 Manufacturing Licence
- MD-15 Import Licence
- Device Classification
- Clinical Evaluation
- Regulatory Consultation
Your Regulatory Partner in India
Regulatory Compliance Made Simple for Healthcare Businesses
Get expert assistance for CDSCO Registration, Medical Device License, Cosmetic Registration, Drug Approval & Regulatory Compliance in India.
- Compliance
- Quality
- Better Healthcare
Our Services
Regulatory Services under CDSCO
End-to-end support for product approval, licensing and compliance.
Cosmetic Registration
End-to-end compliance for imported and manufactured cosmetics.
- COS-1 Import Registration
- Product Categorisation
- Label Review & Compliance
- Ingredient Assessment
- Post Approval Support
- Regulatory Advisory
Drug Registration
Regulatory support for new drugs, clinical trials and import licences.
- Form CT Registration
- Import Licence
- New Drug Permission
- Clinical Trial Approvals
- Regulatory Support
- Lifecycle Management
Why Choose CDSCOIndia.com
Regulatory Expertise
In-depth knowledge of CDSCO regulations and guidelines
Documentation Support
Complete technical and regulatory documentation
End-to-End Support
From application to approval
Global & Local Reach
Support for foreign manufacturers and Indian stakeholders
Our Regulatory Process
A simple and transparent process to get your product approved.
- 1ConsultationUnderstand your product & requirements
- 2DocumentationPrepare regulatory dossier
- 3Application FilingSubmit application with CDSCO
- 4ApprovalReceive license / registration
Industries We Serve
- Medical Devices
- Pharmaceuticals
- Cosmetics
- Healthcare Startups
- Importers
- Manufacturers
- Distributors
Testimonials
Client Success Stories
What manufacturers, importers and brands say about working with our regulatory team.
“
Professional support throughout our CDSCO registration process. Highly recommended!
Medical Device ImporterMD-15 Import Licence
“
Excellent guidance and timely updates for our cosmetic registration. Great team!
Cosmetic BrandCOS-1 Import Registration
“
Very knowledgeable team with deep regulatory expertise. Smooth experience from start to finish.
Pharmaceutical CompanyNew Drug Permission
“
Our MD-5 manufacturing licence was handled end to end. Every query was answered the same day.
Device ManufacturerMD-5 Manufacturing Licence
“
As a foreign manufacturer we needed local guidance. The team made Indian compliance simple for us.
Global ManufacturerMarket Entry Support
“
Clear timelines and complete documentation support. Our import licence came through without delays.
Healthcare DistributorMD-14 Import Licence
4.9 / 5Average client rating
1900+Clients assisted across India
85%Clients return for renewals
FAQ
Frequently Asked Questions
Common questions about CDSCO registration, licences and approvals in India.
CDSCO is India's national regulator for drugs, medical devices and cosmetics. Any manufacturer, importer or distributor who wants to sell these products in India needs the relevant CDSCO licence or registration before the product reaches the market.
Timelines depend on the device class and the quality of the dossier. Once the file is complete and submitted, applications usually move through review, query response and grant stages. We share an expected timeline for your specific device class before starting, and keep you updated at each stage.
Typically you need manufacturer and brand details, product composition, label artwork, free sale certificate, manufacturing licence of the origin country, and an authorisation for the Indian agent. We review your documents first and tell you exactly what is missing.
Yes. A foreign manufacturer must appoint an Indian authorised agent who holds a valid licence and applies on their behalf. We support global manufacturers with agent requirements, documentation and ongoing compliance.
Devices are classified by risk — Class A is lowest risk and Class D is highest. The class decides which licence you apply for and which authority grants it. We do the classification first, because a wrong class means a rejected or delayed application.
Compliance continues after approval — renewals, label changes, post-approval changes, adverse event reporting and record keeping. We handle lifecycle management so your licence stays valid and audit-ready.
Yes. Our head office is in Delhi and we support clients across Mumbai, Bangalore, Hyderabad, Kolkata, Chennai and the rest of India remotely, with documentation and filings handled online.
Still have questions?Talk to a regulatory expert — no charge for the first consultation.
Book Free Consultation
Contact Information
- Our OfficeH-34/7, Sector-3, Rohini,
Delhi – 110085, India - Call Us+91 98999 97002
- Email Usinfo@cdscoindia.com
- Working HoursMonday – Saturday
9:30 AM – 6:30 PM (IST) - General InquiriesFor business queries, collaborations or media inquiries, write to us.
Our Presence
Head Office · Rohini, Delhi
Get Directions
H-34/7, Sector-3, Rohini, Delhi – 110085, India