Navigate India's rigorous regulatory landscape. We provide end-to-end licensing for Medical Devices (MD-14), Drugs (Form 10), and Cosmetics (Form 43) via the SUGAM portal.
Determine your product class and license type.
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. To ensure patient safety, the import, manufacture, and sale of Drugs, Cosmetics, and Medical Devices are regulated under the Drugs and Cosmetics Act, 1940.
Any entity wishing to import these products must register the foreign manufacturing site and the specific products with the CDSCO. For foreign manufacturers, appointing an Indian Authorized Agent (IAA) holding a valid wholesale license is a mandatory prerequisite.
Risk-based classification system (Class A to D).
Low Risk
Thermometers, Bandages, Cotton Wool.
Low-Moderate Risk
Hypodermic Needles, BP Monitors, Ultrasound.
Moderate-High Risk
Dialysis Equipment, Bone Fixation, X-Ray.
High Risk
Heart Valves, Stents, Pacemakers.
Import of drugs requires a dual registration process involving the registration of the manufacturing site and the specific drug products.
Registration Certificate for foreign manufacturing site and products.
Import License for actual import of consignments.
For importing small quantities for Testing, Analysis, or Clinical Trials.
All imported cosmetics must be registered under Form 43 via the SUGAM portal. Labels must comply with Indian standards.
Executed by the foreign manufacturer authorizing the Indian Agent to act on their behalf. Must be apostilled/legalized.
Proof that the product is freely sold in the country of origin. Preferably from GHTF countries (USA, EU, Japan, etc.).
Detailed Site Master File (SMF) describing the manufacturing facility, layout, and quality control systems.
Create account on SUGAM portal as Importer/Authorized Agent.
Prepare technical dossier (Device Master File) & legal documents.
Submit application online and pay official government fees.
Respond to technical queries raised by CDSCO officers.
Import License (MD-14 / Form 10 / Form 43) generated.
End-to-End Support
+ GST (Per Application)
*Government fees are additional and vary by product class ($50 - $1000+).
Pharma and Medical imports are 'Zero-Error' zones. A single typo in a chemical formula or a missing stability report will freeze your supply chain.
We manage your entire profile on the SUGAM Portal. In 2026, this portal is linked to ICEGATE SWIFT 2.0. When you file a Bill of Entry, the Customs system checks the CDSCO database for your specific Batch Number and Expiry Date.
Foreign manufacturers must appoint a local Authorized Agent with a valid wholesale drug license. CloudDesk provides this legal representation, ensuring that you can enter the Indian market without setting up a full subsidiary.
CDSCO isn't over at the port. We manage the Post-Market Surveillance (PMS) reports, Adverse Event reporting, and the mandatory Retention of Samples for every batch imported.
• Class A: Low Risk (e.g., Absorbent cotton, Surgical tape).
• Class B: Low-Moderate Risk (e.g., Needles, Catheters).
• Class C: Moderate-High Risk (e.g., Bone bolts, Lenses).
• Class D: High Risk (e.g., Heart valves, Pacemakers).
Yes, via Form 12A. You can import small quantities for personal use with a valid doctor's prescription, but this is restricted to non-commercial use.
Yes. In-Vitro Diagnostics (IVD) are treated as medical devices. Depending on the disease they detect (e.g., HIV/Malaria), they are usually Class C or D.
In 2026, the RC is valid perpetually, provided the Retention Fee is paid every five years. CloudDesk's "Compliance Calendar" manages these fee payments for you.
It varies by class. For Class A, it's approximately $1,000, scaling up significantly for Class D. CloudDesk provides an exact Fee Estimator based on your product specs.
If you import a chemical that could be used as a drug but you are using it for industrial purposes, you need a Dual-Use NOC from the CDSCO to clear Customs.