CDSCO License & Approval in India: Registration, Fees, Process & Documents
2026 CDSCO Regulatory Update: CDSCO's regulatory framework continues to evolve under the Medical Devices Rules, 2017 (MDR-2017). Recent official publications include updated risk-classification lists (including 2025/2026 classifications for Oncology, Radiotherapy, and Interventional Radiology), guidance for Medical Device Software, and updated registration frameworks for specified Class A non-sterile, non-measuring (NSNM) devices. Always verify your specific product standard against the latest CDSCO notification prior to application submission.
What Is CDSCO License and Approval in India?
The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), is the national regulatory body for pharmaceuticals, medical devices, cosmetics, and IVDs under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
CDSCO approval guarantees that healthcare products manufactured in or imported into India meet rigorous standards for safety, quality, and efficacy. There is no single "CDSCO License." Instead, the regulatory framework issues specific licenses, registrations, or permissions tailored to:
The Product Category (Drug, Medical Device, IVD, Cosmetic).
The Risk Classification (Class A, B, C, or D for devices).
The Business Activity (Manufacturing, Import, Sale, Distribution, Testing).
The Entity Origin (Domestic Indian Manufacturer vs. Foreign Manufacturer importing via an Authorized Agent).
Which CDSCO Pathway Applies to Your Product?
Is your product regulated under the Drugs and Cosmetics Act?
Medical Device or IVD - Determine Risk Class (A, B, C, D)
Domestic Mfg - SLA (Class A/B) or CLA (Class C/D)
Import - Central Licensing Authority (CLA)
Pharmaceutical / Drug - New Drug Approval (CLA) or Mfg License (SLA)
Cosmetic - Import Registration (CLA) or Mfg License (SLA)
CDSCO License vs CDSCO Registration vs CDSCO Approval
Using regulatory terminology correctly prevents application rejection, wrong fee payment, and compliance delays.
Who Needs a CDSCO License in India?
Domestic Manufacturers: Manufacturing facilities producing active pharmaceutical ingredients (APIs), finished formulations, cosmetics, or medical devices in India.
Importers: Companies importing covered drugs, medical devices, IVDs, or cosmetics into India for commercial distribution.
Foreign Manufacturers: Overseas manufacturing plants exporting regulated healthcare products to India (acting through an Indian Authorized Agent).
Clinical Research Entities: Organizations conducting clinical trials or bioequivalence/bioavailability (BA/BE) studies in India.
R&D / Test License Applicants: Facilities manufacturing or importing small quantities of non-approved items for testing, analysis, or clinical evaluation.
Which Products Come Under CDSCO?
1. Medical Devices
Medical devices are regulated in India under the Medical Devices Rules, 2017 (MDR-2017). Products are categorized into four risk classes:
Class A: Low Risk (e.g., surgical dressings, manual wheelchairs, specified non-sterile/non-measuring instruments).
Class B: Low-to-Moderate Risk (e.g., hypodermic needles, suction pumps, diagnostic X-ray equipment).
Class C: Moderate-to-High Risk (e.g., hemodialysis machines, bone fixation plates, infusion pumps).
Class D: High Risk (e.g., cardiac pacemakers, coronary stents, implantable defibrillators).
2. In-Vitro Diagnostics (IVDs)
In-vitro diagnostic devices, reagents, and kits follow a similar risk-based classification scheme (Class A to D IVDs) covering blood glucose strips, HIV test kits, PCR reagents, and automated analyzers.
3. Pharmaceuticals & Biologicals
Covers New Chemical Entities (NCEs), Active Pharmaceutical Ingredients (APIs), finished formulations, vaccines, blood products, gene therapy products, and biosimilars.
4. Cosmetics
Imported cosmetics must obtain registration before entering India under the Cosmetics Rules, 2020. Domestic cosmetic production requires licensing from the state authority.
Medical Device Classification & Licensing Authorities
The licensing path and approving authority depend directly on the device's assigned risk class.
Class A NSNM Device Registration
Specified Class A Non-Sterile, Non-Measuring (NSNM) devices are subject to an online registration workflow rather than a full manufacturing license. However, if the Class A device is supplied sterile or has a measuring function, it requires formal licensing.
Types of CDSCO Licenses & Application Forms
Key Medical Device Forms under MDR-2017
CDSCO Registration Process: Step-by-Step
Step 1: Product & Category Identification
Step 2: Risk Classification (Class A, B, C, or D)
Step 3: Determine Authority (SLA vs Central CDSCO/CLA)
Step 4: Prepare Technical Dossier & Quality Documentation (ISO 13485 / GMP)
Step 5: Account Creation on SUGAM / CDSCO Portal
Step 6: Online Application Submission & Government Fee Payment
Step 7: Regulatory Scrutiny & Deficiency Letter (if applicable)
Step 8: On-Site Audit / Technical Assessment (Notified Body or CDSCO Inspector)
Step 9: Grant of Approval / License (Form MD-5, MD-9, or MD-15)
Step 10: Post-Approval Maintenance & Retention Fee Compliance
Process Highlights
SUGAM Portal Registration: Applications are filed electronically via CDSCO’s official SUGAM / Online Medical Devices System.
Dossier Evaluation: Technical documentation (Plant Master File, Device Master File, Risk Management Reports, Test Reports) is evaluated by CDSCO officers or technical committees.
Audit & Inspection: For domestic Class B, C, and D manufacturing applications, on-site quality management system (QMS) audits are conducted by accredited Notified Bodies or CDSCO medical device officers.
Deficiency Resolution: If CDSCO issues queries or clarification requests, applicants must submit complete responses within prescribed regulatory timelines.
Documents Required for CDSCO License
1. General Business & Entity Documents
Certificate of Incorporation / Business Registration Certificate
Permanent Account Number (PAN) & Goods and Services Tax (GST) Registration
Site Plan and Factory / Premises Layout Plan
Authorization Letter for the Designated Authorized Signatory
Contact Details and Credentials of Technical Staff (Production & Testing)
2. Product Technical Documentation (Device Master File - DMF)
Full Product Description, intended use, and technical specifications
Material Breakdown and Biocompatibility Evaluation Data
Risk Management File complying with ISO 14971
Product Labels, Package Inserts, and Instructions for Use (IFU)
Test Reports (Performance testing, electrical safety, EMC, bench testing)
Clinical Evidence, Evaluation Reports, or Predicate Device Information
3. Quality System Documentation (Plant Master File - PMF)
ISO 13485:2016 Certificate for the manufacturing facility
Quality Management System (QMS) manual and process controls
Validation and calibration records for production and test equipment
Stability study reports and shelf-life verification
4. Additional Documents for Foreign Manufacturers / Import License
Power of Attorney (PoA) appointing the Indian Authorized Agent (IAA)
Wholesale License (Form 20B/21B) held by the Indian Authorized Agent
Free Sale Certificate (FSC) or Certificate to Foreign Government (CFG) from the country of origin
Certificate of Marketability from regulatory authorities (e.g., US FDA, EU CE)
CDSCO License Fees in India
Fee Note: Government fees vary significantly based on product category, risk classification, number of distinct sites, and individual product variants/models.
Indicative Medical Device Government Fee Framework (MDR-2017 Schedule)
Ancillary Costs to Budget
Notified Body Audit Fees: Charged directly by designated Notified Bodies for auditing domestic Class B manufacturing sites.
Testing Fees: Charged by accredited testing laboratories for safety and performance testing.
Consularization / Apostille Charges: Legalizing Power of Attorney and overseas regulatory documents.
Read More: CDSCO Registration for Cosmetic
CDSCO Approval Timelines
The timeline for securing a CDSCO license depends on product complexity, audit scheduling, dossier completeness, and testing requirements.
Class A (NSNM) Registration - 2 to 4 Weeks
Class A / B Manufacturing License - 2 to 4 Months (Includes Notified Body Audit)
Class C / D Manufacturing License - 4 to 9 Months (Includes CDSCO CLA Audit)
Medical Device Import License - 3 to 6 Months (Subject to Dossier Review)
New Drug / Novel Device Approval - 6 to 12+ Months (Includes Technical Committee Review)
CDSCO Registration for Foreign Manufacturers
Foreign manufacturers exporting products to India cannot apply directly to CDSCO. They must execute their regulatory filings through an Indian Authorized Agent (IAA).
Foreign Manufacturer
(Executes Power of Attorney)
Indian Authorized Agent (IAA)
[Must hold valid Wholesale License: Form 20B/21B]
(Submits MD-14 on SUGAM)
CDSCO Central Licensing Authority (CLA)
(Issues Import License)
Form MD-15 Issued to Indian Authorized Agent
Key Responsibilities of the Indian Authorized Agent
Acting as the primary legal liaison between the foreign manufacturer and CDSCO.
Holding and managing the Form MD-15 Import License.
Monitoring post-market surveillance (PMS), adverse event reporting, and product recalls in India.
Maintaining technical dossiers and regulatory records locally.
CDSCO License Validity & Retention Framework
Perpetual Validity: Under the Medical Devices Rules, 2017, licenses granted by CDSCO remain valid perpetually, provided the license holder pays the prescribed Retention Fee before the end of every 5-year period.
Retention Fee Window: The retention fee must be deposited prior to the completion of the 5-year cycle from the date of license issuance. Failure to pay before the due date results in late fee penalties or license cancellation.
License Endorsements: Subsequent changes (e.g., adding new models, changing site address, or updating packaging) require formal endorsement applications on the SUGAM portal.
Common CDSCO Registration Mistakes to Avoid
Incorrect Device Classification: Selecting a lower risk class without validating against official CDSCO classification lists, leading to application rejection.
Inconsistent Intended Use Statements: Differences between the intended use declared in the application, the Device Master File, and product labeling.
Discrepancy in Product Names: Inconsistencies between the brand name/model numbers on the Free Sale Certificate and the SUGAM application form.
Uncalibrated Equipment Logs: Submitting manufacturing dossiers with expired calibration or validation records for essential equipment.
Ignoring Post-Market Obligations: Failing to establish a documented process for handling customer complaints, vigilance reporting, and corrective and preventive actions (CAPA).
Post-Approval CDSCO Compliance Framework
Obtaining your CDSCO license is the beginning of ongoing regulatory responsibilities:
Post-Market Surveillance (PMS): Collect and evaluate quality and performance data from commercial usage in India.
Materia Vigilance Programme of India (MvPi): Report adverse events, serious medical device incidents, or device malfunctions to CDSCO within statutory timeframes.
Change Control: Obtain approval or submit notifications prior to changing raw materials, manufacturing sites, or product design specifications.
Customs Compliance: Ensure the MD-15 import license number and labeling details match all shipping manifests and bills of entry.
Downloadable CDSCO Application Checklist
Pre-Application Verification
Product category verified (Drug / Device / IVD / Cosmetic)
Risk Class (A, B, C, D) cross-referenced with CDSCO notification lists
Approving authority identified (SLA vs CDSCO CLA)
Entity eligibility verified (Manufacturing site license or Wholesale license for IAA)
Technical Dossier Preparation
Device Master File (DMF) completed with testing & clinical reports
Plant Master File (PMF) completed with QMS & ISO 13485 certification
Risk Management Report (ISO 14971) finalized
Artwork for Labels & Package Inserts aligned with Indian labeling rules
Submission & Post-Submission
User profile created on SUGAM portal
Application forms filled and electronically signed
Government fees paid online
Deficiency queries tracked and answered within regulatory timelines
Frequently Asked Questions (FAQs)
Is CDSCO registration mandatory for all medical devices in India?
Yes. Under the Medical Devices Rules, 2017, all medical devices imported into or manufactured in India require regulatory registration or licensing.
What is the SUGAM portal?
SUGAM is CDSCO's official online portal used to submit, track, and process regulatory applications for drugs, medical devices, cosmetics, and clinical trials.
Can a foreign company hold a CDSCO license directly?
No. Foreign companies must appoint an Indian Authorized Agent (IAA) who holds a valid wholesale drug/device license in India to apply for and hold the import license on their behalf.
What is the difference between Form MD-14 and Form MD-15?
Form MD-14 is the application form submitted to CDSCO to request an import license for medical devices. Form MD-15 is the final import license issued by CDSCO upon approval.
Does ISO 13485 certification replace CDSCO approval?
No. ISO 13485 is a quality management system standard. While it is a mandatory document within the CDSCO application dossier, it does not replace the requirement to obtain a statutory CDSCO license.
Strategic Compliance Summary
Determine exact product parameters: Confirm whether your product is a drug, cosmetic, IVD, or medical device, and establish its exact risk classification.
Identify the approving body: Direct Class A/B domestic manufacturing applications to the State Licensing Authority, and all import or Class C/D manufacturing filings to the Central Licensing Authority.
Ensure dossier consistency: Verify that technical specifications, labels, Free Sale Certificates, and portal application fields match before filing.
Maintain ongoing retention: Track 5-year retention fee deadlines to ensure your perpetual license remains valid without interruption.
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