CDSCO Certification & Licensing
Streamline Your Regulatory Approvals for Medical Devices & Healthcare Tech in India
Navigating India's healthcare regulatory framework requires precision, deep expertise, and thorough compliance with the Drugs and Cosmetics Act and the Medical Devices Rules (MDR).
At OM GARUDA GROUP, we provide end-to-end consultancy for obtaining CDSCO Medical Device Licenses and Registration. Whether you are an international OEM exporting to India or a domestic manufacturer, our senior regulatory strategists streamline classification, testing, device master file (DMF) compilation, and central licensing through the official SUGAM and MDONLINE portals—ensuring rapid, fully compliant entry into India’s growing medical device market.
Request a QuoteComprehensive CDSCO Compliance Services
We provide complete, turn-key regulatory management for all classes of medical technology:
Device Risk Classification & Covered Categories
Under CDSCO guidelines, medical devices are classified according to risk. We assist across all four statutory tiers:
| Device Risk Class | Risk Profile | Example Products | Licensing Authority |
|---|---|---|---|
| Class A | Low Risk | Surgical Gauze, Thermometers, Stethoscopes, Nebulizers | State Licensing Authority (SLA) |
| Class B | Low-Moderate Risk | Hypodermic Needles, Suction Pumps, Diagnostic Kits, BP Monitors | State Licensing Authority (SLA) |
| Class C | Moderate-High Risk | Dialyzers, Implants, Ventilators, X-Ray Machines, Anesthesia Equipment | Central Licensing Authority (CLA) |
| Class D | High Risk | Pacemakers, Stents, Heart Valves, Critical Diagnostic Assays | Central Licensing Authority (CLA) |
End-to-End Service Execution
Risk Classification & Standard Mapping
We review your product design, intended use, and specifications to determine the correct risk class and applicable Indian/ISO standards.
Device Master File (DMF) & Plant Master File (PMF) Compilation
Our technical documentation team compiles your technical dossiers, risk management files, labeling proofs, and ISO 13485 audit documents in the precise format mandated by CDSCO.
Online Portal Submission & Audit Defense
Filing through official CDSCO portals (SUGAM / MDONLINE), addressing technical query letters from notified bodies or regulators, and supporting physical factory/warehouse inspections.
Why Choose OM GARUDA GROUP for Healthcare Regulatory Approvals?
12+ Years of Multi-Domain Compliance Experience
Deep familiarity with CDSCO updates, Central and State authority procedures, and customs clearance requirements.
High First-Pass Approval Rate
Meticulous dossier reviews eliminate missing documentation and prevent application rejections or delays.
Seamless Cross-Certification
We handle your CDSCO, BIS Registration, WPC (for wireless med-tech), and EPR simultaneously, giving you a single window for all product approvals.
End-to-End Representation
Active liaison with licensing officers and notified bodies to fast-track your certification lifecycle.
The Step-by-Step CDSCO Licensing Workflow
Gap Analysis & File Preparation
Technical review of your Device Master File, Quality Management System (QMS), and testing certificates.
Authorized Indian Agent Appointment
Finalizing local legal representation for foreign manufacturers.
Portal Filing & Fee Submission
Submitting comprehensive documentation via the CDSCO online portal.
Audit & Testing Verification
Coordinating evaluation with recognized testing laboratories or notified bodies.
License Issuance & Maintenance
Grant of official Import/Manufacturing License and ongoing compliance support for renewals and amendments.
CDSCO Certification & Regulatory Licensing Services
Navigate Medical Device & Cosmetic Approvals with Confidence
Bringing medical technology, diagnostics, or cosmetics into the Indian market requires total adherence to statutory mandates defined by the Central Drugs Standard Control Organisation (CDSCO), the Drugs and Cosmetics Act, and the Medical Device Rules (MDR).
At OM GARUDA GROUP, we provide complete, professional support to streamline CDSCO approvals for local manufacturers, global OEMs, and importers. From device risk classification and clinical evaluation dossier assembly to portal submissions via the SUGAM and Medical Devices portals, we remove regulatory friction so your healthcare products reach the market safely and on schedule.
Core CDSCO Service Offerings
Medical Device Certification (MDR compliance)
Full classification, dossier preparation, and licensing support for domestic and international medical device manufacturers across all risk categories:
- Class A & B Devices (Low to Moderate Risk): Application compilation and State Licensing Authority (SLA) submission for manufacturing/import licenses.
- Class C & D Devices (Moderate-High to High Risk): Comprehensive Technical Dossier compilation (Plant Master File & Device Master File) for Central Licensing Authority (CLA) review.
- In Vitro Diagnostics (IVD): Regulatory approvals for diagnostic kits, reagents, and analyzer systems.
- Test Licenses & Clinical Evaluations: Procurement of Form MD-13 / Form MD-17 test licenses for evaluation, testing, or clinical trial purposes.
Cosmetic Import Registration
End-to-end guidance under the Cosmetics Rules for foreign cosmetics brands and Indian importers:
- Form COS-1 / COS-2 Import Registration Certificates: Complete dossier compilation, ingredient concentration checking, and SUGAM portal filing.
- Labeling & Composition Compliance: Auditing ingredient safety declarations (heavy metal limits, banned substances) and packaging layouts against Indian standards.
Authorized Indian Agent (AIA) Support
Acting as or coordinating with an Authorized Indian Representative to represent foreign manufacturers without a physical presence in India before the CDSCO licensing authorities.
Why Choose OM GARUDA GROUP for CDSCO?
Navigating medical and healthcare regulations in India demands zero errors. Here is why leading global medical device manufacturers and cosmetic brands partner with OM GARUDA GROUP:
12+ Years of Core Regulatory Mastery
Deep expertise in the Drugs and Cosmetics Act and Medical Device Rules (MDR). We know exactly how licensing authorities evaluate technical files, preventing costly query cycles.
Flawless Dossier Preparation
Our technical team audits and compiles your Device Master File (DMF), Plant Master File (PMF), and ISO 13485 Quality Management System (QMS) documentation to ensure first-time submission approval.
End-to-End Handholding
From initial risk classification and lab sample testing coordination to post-market surveillance records and renewal management, we manage the entire lifecycle.
Proactive Query Resolution
If regulatory officials raise technical queries during assessment, our senior consultants handle draft clarifications and direct liaison to resolve them quickly.
Unified Compliance Strategy
We integrate CDSCO certifications with BIS Registration, WPC Approvals, and Legal Metrology (LMCR), providing a single-window compliance solution for complex medical hardware.
4-Step CDSCO Licensing Workflow
Product Mapping & Risk Classification
Mandatory first step under Medical Device Rules & Cosmetics Rules.We audit your product formulations or device specifications to determine the correct Risk Class (Class A, B, C, or D) and identify applicable Indian Standards.
Technical File & Dossier Assembly
Quality Management & Plant/Device Master Files.Compilation of ISO 13485 certificates, Free Sale Certificates, clinical performance data, ingredient safety declarations, and manufacturing layouts.
Portal Submission & Official Follow-Up
Filing via SUGAM / Medical Devices Portals.Filing of online applications (Form MD series or Form COS series) with fee processing through Bharatkosh and proactive query management with CDSCO officials.
Grant of License & Market Entry
Issuance of perpetual or fixed-term certificates.Receiving the official Manufacturing/Import License or Registration Certificate, allowing legal sale and distribution across India.
Frequently Asked Questions (FAQs)
Medical Devices & Diagnostics
What criteria determine the risk classification of a medical device in India?
Under the Medical Device Rules (MDR), CDSCO classifies devices into four categories based on intended use and risk parameters:
Class A: Low Risk (e.g., surgical scalpels, non-sterile dressings)
Class B: Low-to-Moderate Risk (e.g., hypodermic needles, suction catheters)
Class C: Moderate-to-High Risk (e.g., hemodialysis catheters, vascular scaffolds)
Class D: High Risk (e.g., cardiac stents, implantable pacemakers)
Is CDSCO certification mandatory for all medical devices sold in India?
Yes. Regulatory notifications bring all medical devices and in vitro diagnostic (IVD) devices under the mandatory purview of the Medical Device Rules. Manufacturing or importing without a valid license or registration is a punishable offense.
How long is a CDSCO Medical Device License valid?
Licenses issued under the Medical Device Rules (such as Import Licenses or Manufacturing Licenses) remain valid in perpetuity, provided the license retention fee is deposited every 5 years.
Do foreign manufacturers need a local representative in India?
Yes. Overseas manufacturers without a registered office in India must appoint an Authorized Indian Agent (AIA) holding a valid wholesale license to submit applications and assume regulatory responsibility before the CDSCO.
Cosmetics & Personal Care Products
What approvals are required to import cosmetics into India?
All imported cosmetic products must obtain an Import Registration Certificate (Form COS-2) by filing an application in Form COS-1 via the CDSCO SUGAM portal.
Are animal-tested cosmetics allowed to be imported into India?
No. Indian regulations strictly prohibit the import and sale of cosmetic products that have undergone animal testing. Applicants must submit an official Non-Animal Testing Declaration alongside their registration dossier.
How long does the CDSCO cosmetic import registration take?
The typical turnaround time for cosmetic import registration ranges between 3 to 6 months, depending on document readiness, ingredient verifications, and regulatory queries raised during assessment.
Get Started with CDSCO Registration
Speak to our senior compliance consultants for a free, no-obligation assessment of your CDSCO Registration requirements.