End-to-end CDSCO services — Medical Device Import Licence (MD-14/MD-15), State & Central Manufacturing Licences (MD-5/MD-9), Cosmetic Import Registration (COS-1/COS-2), Drug Import Registration (Form 40/41) and Authorised Indian Agent representation — handled by regulatory experts.
Our CDSCO experts will contact you within 24 hours.
Complete online submission & query handling on CDSCO's SUGAM portal.
We act as or arrange your mandatory Indian Agent / Representative.
Expert Device & Plant Master File and STED dossier preparation.
Fast, technically-sound responses so your file is never auto-rejected.
Ongoing retention, endorsement & renewal management.
Overview
CDSCO is the gateway to India's regulated market for medical devices, cosmetics, drugs and diagnostics. Any manufacturer, importer or brand owner selling these products in India must hold the correct CDSCO licence or registration.
The Central Drugs Standard Control Organisation (CDSCO) is India's National Regulatory Authority (NRA), functioning under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It is headed by the Drugs Controller General of India (DCGI) and operates through zonal, sub-zonal, port and laboratory offices across the country.
CDSCO regulates the import, manufacture, sale and distribution of drugs, cosmetics, medical devices and in-vitro diagnostics (IVDs), along with the approval of new drugs, clinical trials, vaccines and blood products. Its authority flows from the Drugs and Cosmetics Act, 1940 & Rules 1945, the Medical Devices Rules, 2017, the Cosmetics Rules, 2020 and the New Drugs and Clinical Trials Rules, 2019.
Overseas makers of devices, cosmetics or drugs exporting to India.
Indian entities importing regulated products for sale.
Indian factories producing medical devices, IVDs or cosmetics.
Companies marketing regulated products under their own label.
Device Classification
Under the Medical Devices Rules, 2017, every device and IVD is placed in one of four risk classes. The class decides the licensing authority, the form and the fee.
| Class | Risk Level | Licensing Authority | Examples |
|---|---|---|---|
| Class A | Low | State (SLA) | Surgical dressings, cotton, thermometers, tongue depressors |
| Class B | Low–Moderate | State (SLA) | BP monitors, glucometers, hypodermic needles, suction equipment |
| Class C | Moderate–High | Central (CDSCO) | Ventilators, dialysis machines, bone-fixation plates, IVD analysers |
| Class D | High | Central (CDSCO) | Heart valves, pacemakers, coronary stents, implantable devices |
Licence Types
CDSCO issues distinct licences by product type and activity. Choose the right pathway for your product and business model.
| Activity / Product | Application → Licence | Authority | Validity |
|---|---|---|---|
| Medical Device — Import (all classes) | Form MD-14 → MD-15 | Central (CDSCO) | Perpetual* |
| Medical Device — Manufacture (A & B) | Form MD-3 → MD-5 | State (SLA) | Perpetual* |
| Medical Device — Manufacture (C & D) | Form MD-7 → MD-9 | Central (CDSCO) | Perpetual* |
| Loan Licence (A & B / C & D) | MD-4 → MD-6 / MD-8 → MD-10 | SLA / CDSCO | Perpetual* |
| Test Licence | Form MD-12 → MD-13 | Central (CDSCO) | Per licence |
| Cosmetic — Import Registration | Form COS-1 → COS-2 | Central (CDSCO) | 5 Years |
| Drug — Import Registration | Form 40 → Form 41 | Central (CDSCO) | 3 Years |
| Drug — Import Licence | Form 8 → Form 10 | Central (CDSCO) | Linked to RC |
*Perpetual = valid unless suspended or cancelled, subject to a retention fee paid every 5 years.
Our Process
From appointing your Authorised Indian Agent to the final MD-15 grant, we manage the entire SUGAM submission, dossier and query cycle.
We confirm the correct risk class (A–D) and licensing route for your device or IVD.
Appoint an Indian Agent holding a valid wholesale / manufacturing / import licence.
Compile the Device Master File, Plant Master File, ISO 13485, Free Sale Certificate & PoA.
Submit the online application and government fees through the SUGAM portal.
Technical evaluation; we respond to all queries within the strict 90-day window.
The import licence is issued digitally — valid for customs clearance & sale.
Requirements
Requirements vary by product type and licence. Our team issues a personalised checklist after the first call.
Government Fees
Government fees under the Medical Devices Rules 2017 and Cosmetics Rules 2020. These are statutory fees only and are separate from professional / consulting charges.
| Licence | Class / Type | Site Fee | Per Distinct Device / Variant |
|---|---|---|---|
| Import — MD-15 (non-IVD) | Class A | USD 1,000 | USD 50 |
| Class B | USD 2,000 | USD 1,000 | |
| Class C / D | USD 3,000 | USD 1,500 | |
| Import — MD-15 (IVD) | Class A/B — C/D | USD 1,000 – 3,000 | USD 10 – 500 |
| Manufacture — MD-5 | Class A & B | ₹5,000 | ₹500 |
| Manufacture — MD-9 | Class C & D | ₹50,000 | ₹1,000 |
| Test Licence — MD-13 | All classes | — | ₹500 per device |
| Cosmetic — COS-2 | Import registration | USD 1,000 / category | USD 50 / variant (+ USD 500 / site) |
| Drug — Form 41 | Import registration | USD 1,500 / site | USD 1,000 / drug |
Product Scope
CDSCO covers a vast range of health, diagnostic and cosmetic products. If your product touches the human body or health, it is likely regulated.
Don't let regulatory complexity delay your product launch or customs clearance. Our experts handle your entire CDSCO journey — accurately, and on time.
FAQ
Common questions about CDSCO registration, import licences and the SUGAM process in India.
CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority under the Ministry of Health & Family Welfare, headed by the DCGI. It regulates the import, manufacture, sale and distribution of drugs, cosmetics, medical devices and IVDs under the Drugs and Cosmetics Act 1940, the Medical Devices Rules 2017 and the Cosmetics Rules 2020.
No. A foreign manufacturer cannot hold a CDSCO import licence directly. It must appoint an Authorised Indian Agent (Authorised Indian Representative) holding a valid wholesale, manufacturing or import licence in India, who files on SUGAM and carries legal responsibility for the product. Global Approbation provides Authorised Indian Agent services.
The application is filed in Form MD-14 and, on approval, the import licence is granted in Form MD-15 by the Central Licensing Authority (CDSCO) for all device classes A–D.
For non-IVD devices: Class A — USD 1,000/site + USD 50/device; Class B — USD 2,000/site + USD 1,000/device; Class C & D — USD 3,000/site + USD 1,500/device. IVD per-device fees are lower. These are official Medical Devices Rules 2017 fees.
An MD-15 import licence typically takes 6–9 months (up to 12–18 months for complex Class C/D without a predicate). MD-5 (state manufacture) takes ~3–6 months, MD-9 (central) ~6–9 months, and a test licence (MD-13) ~3–4 weeks.
Device manufacturing and import licences are perpetual — valid unless suspended or cancelled — subject to a retention fee every 5 years. Cosmetic import registration (COS-2) is valid for 5 years and renewable. Drug import registration (Form 41) is valid for 3 years.
SUGAM is CDSCO's mandatory online portal for all applications — no physical filing is accepted. Any query raised must be answered within 90 days, or the application is auto-rejected and fees are forfeited. Expert query management is therefore essential.
We act as or arrange your Authorised Indian Agent, prepare the DMF/PMF and technical dossier, file MD-14/MD-15, COS-1/COS-2, Form 40/41 and test licences on SUGAM, manage all queries within 90 days, and handle retention and renewals — a single accountable partner end to end.
Get In Touch
Reach out for a free consultation. Our team responds within 24 hours.
We'll get back to you with a customised quote and timeline.
Related Services
Products entering India often require more than one approval. These are the services clients most commonly combine with CDSCO registration.