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Any company that wants to import, manufacture or sell medical devices, in-vitro diagnostics (IVDs), cosmetics or drugs in India must first obtain approval from the Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory authority for health products, and its licence is the legal gateway to the Indian market. This guide explains, in verified detail, every CDSCO licence type, the risk-based classification of medical devices, the SUGAM portal process, documents required, official government fees, timelines and validity — plus how PCN India Global manages the entire process for foreign manufacturers and importers.
India is one of the fastest-growing markets in the world for medical devices, pharmaceuticals and cosmetics. To protect public health, the Government of India requires that every regulated health product placed on the Indian market carries a valid CDSCO licence or registration. Whether you are a foreign manufacturer, an importer, a domestic manufacturer or a brand owner, CDSCO approval is a legal precondition for customs clearance and commercial sale.
CDSCO registration is not a single licence but a family of licences and registrations that differ by product type (device, IVD, cosmetic, drug) and by activity (import, manufacture, testing, loan manufacture). Choosing the correct pathway at the outset is the single biggest factor in a fast, first-time approval.
The Central Drugs Standard Control Organisation is India’s National Regulatory Authority (NRA) for health products. It functions under the Directorate General of Health Services within the Ministry of Health & Family Welfare, and is headed by the Drugs Controller General of India (DCGI).
| Particular | Details |
|---|---|
| Full Name | Central Drugs Standard Control Organisation (CDSCO) |
| Ministry | Ministry of Health & Family Welfare, Government of India |
| Head | Drugs Controller General of India (DCGI) |
| Headquarters | FDA Bhawan, Kotla Road, New Delhi |
| Online Portal | SUGAM (online application & licensing system) |
| Key Laws | Drugs and Cosmetics Act 1940 & Rules 1945; Medical Devices Rules 2017; Cosmetics Rules 2020; New Drugs & Clinical Trials Rules 2019 |
CDSCO’s remit covers the entire life cycle — import, manufacture, sale, distribution and clinical evaluation — of the following product categories:
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Overseas makers of medical devices, cosmetics or drugs who wish to export to India. They cannot hold a licence directly and must appoint an Authorised Indian Agent.
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Indian entities importing regulated products for sale — they typically hold the import licence and act as the Indian Agent.
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Indian factories producing devices, IVDs, cosmetics or drugs require the relevant manufacturing licence (state or central).
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Companies marketing regulated products under their own label, including loan-licence and third-party manufacturing arrangements.
Under the Medical Devices Rules, 2017, every medical device and IVD is placed into one of four risk-based classes. The class determines the licensing authority, the application form and the government 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 |
| Product / Activity | Application → Licence | Authority | Validity |
|---|---|---|---|
| Medical Device — Import (all classes) | Form MD-14 → MD-15 | Central (CDSCO) | Perpetual* |
| Medical Device — Manufacture (Class A & B) | Form MD-3 → MD-5 | State (SLA) | Perpetual* |
| Medical Device — Manufacture (Class C & D) | Form MD-7 → MD-9 | Central (CDSCO) | Perpetual* |
| Medical Device — Loan Licence | MD-4 → MD-6 (A/B); MD-8 → MD-10 (C/D) | SLA / CDSCO | Perpetual* |
| Medical Device — 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.
Determine the correct risk class (A–D) and the applicable licensing route. Misclassification is the most common cause of rejection.
A foreign manufacturer must appoint an Indian Agent who holds a valid wholesale, manufacturing or import licence. The agent files the application and holds legal responsibility for the product in India.
Compile the Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, Free Sale Certificate, Power of Attorney and supporting regulatory approvals (CE, US FDA, etc.).
Submit the application and government fees electronically on the SUGAM portal. All CDSCO filings are fully online.
CDSCO carries out a technical evaluation and may raise queries. Each query must be answered within the 90-day window or the application is auto-rejected with fee forfeiture.
On satisfactory review, the import licence is issued in Form MD-15 — valid for customs clearance and commercial sale across India.
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The following are official statutory fees under the Medical Devices Rules 2017 and Cosmetics Rules 2020, separate from professional/consulting charges. Government fees can change — always verify current rates on the SUGAM portal at the time of filing.
| Class | Site Fee | Per Distinct Device |
|---|---|---|
| Class A | USD 1,000 | USD 50 |
| Class B | USD 2,000 | USD 1,000 |
| Class C & D | USD 3,000 | USD 1,500 |
IVD import fees per distinct device are lower (approx. USD 10 for Class A/B, USD 500 for Class C/D), with the same site fees.
| Licence | Site / Base Fee | Per Device / Variant / Drug |
|---|---|---|
| Manufacturing MD-5 (Class A & B) | ₹5,000 | ₹500 per device |
| Manufacturing MD-9 (Class C & D) | ₹50,000 | ₹1,000 per device |
| Test Licence MD-13 | — | ₹500 per device |
| Cosmetic Import Registration COS-2 | USD 1,000 per category (+ USD 500 per site) | USD 50 per variant |
| Drug Import Registration (Form 41) | USD 1,500 per site | USD 1,000 per drug |
| Licence | Typical Timeline |
|---|---|
| Import Licence — MD-15 | 6–9 months (up to 12–18 months for complex Class C/D without predicate) |
| Manufacturing — MD-5 (State, Class A/B) | 3–6 months (includes Notified Body audit) |
| Manufacturing — MD-9 (Central, Class C/D) | 6–9 months (includes CDSCO inspection) |
| Test Licence — MD-13 | 3–4 weeks |
| Cosmetic Import Registration — COS-2 | 3–6 months |
Medical device manufacturing and import licences (MD-5, MD-9, MD-15) are perpetual — they remain valid unless suspended or cancelled, provided a retention fee is paid every 5 years. The retention fee equals the original site and per-device fees.
Cosmetic import registration (COS-2) is valid for 5 years and renewable with a retention fee (late renewal attracts a monthly penalty; beyond 180 days a fresh COS-1 filing is required). Drug import registration (Form 41) is valid for 3 years.
Every cosmetic imported into India must be registered with CDSCO before customs clearance. The importer or an Authorised Indian Agent files Form COS-1 on SUGAM; on approval, the Registration Certificate is issued in Form COS-2, valid for 5 years. Government fees are USD 1,000 per category plus USD 50 per variant (and USD 500 per additional manufacturing site). Imported cosmetics must also comply with Indian labelling rules — see our Legal Metrology (LMPC) service.
To import a drug into India, the overseas manufacturing site and each drug must first obtain a Registration Certificate in Form 41 (applied for in Form 40), followed by an Import Licence in Form 10 (applied for in Form 8). The registration fee is USD 1,500 per manufacturing site plus USD 1,000 per drug, and the certificate is valid for 3 years. New drugs additionally require DCGI approval under the New Drugs and Clinical Trials Rules 2019.
PCN India Global handles your entire CDSCO journey — classification, Authorised Indian Agent, dossier, SUGAM filing, query handling and renewals — with a 100% focus on first-time approval. Call +91-9289587478 or email info@pcnindiaglobal.com to start your application today.
CDSCO registration is the licence or approval granted by the Central Drugs Standard Control Organisation to legally import, manufacture or sell medical devices, IVDs, cosmetics or drugs in India.
No. A foreign manufacturer must appoint an Authorised Indian Agent who holds a valid wholesale, manufacturing or import licence and files the application on SUGAM on their behalf.
The application is filed in Form MD-14 and the import licence is granted in Form MD-15 by 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.
An MD-15 import licence typically takes 6–9 months; state manufacturing (MD-5) 3–6 months; central manufacturing (MD-9) 6–9 months; a test licence (MD-13) 3–4 weeks.
Device manufacturing and import licences are perpetual, subject to a retention fee every 5 years. Cosmetic COS-2 is valid 5 years; drug Form 41 is valid 3 years.
SUGAM is CDSCO’s mandatory online portal for all licence and registration applications. Any query must be answered within 90 days or the file is auto-rejected.
Yes. In addition to COS-2 registration, imported cosmetics must meet Indian packaging/labelling rules under Legal Metrology (LMPC).
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