Medical Devices & Cosmetics Regulatory Compliance in India.
Mandatory authorization for importing, manufacturing, and selling regulated healthcare products in India
For medical devices, pharmaceuticals, and cosmetics requiring approval to sell in India. We help businesses secure necessary licenses and maintain regulatory compliance.
Yes — CDSCO registration is compulsory for all Class A, B, C & D medical devices and regulated cosmetic or drug-related products.
Without approval, products cannot be imported, manufactured, marketed, or sold in India.
Non-compliance may result in:
This compliance applies to:
Any establishment involved in handling regulated medical goods must hold the required license before commercial operations.
Examples include:
License Type | Purpose |
Import License | Required for importing regulated medical devices or cosmetics |
Manufacturing License | Required for producing medical devices or cosmetics in India |
Wholesale License | For businesses distributing or supplying regulated products |
Retail Drug License (Pharmacy) | Required for medical retail outlets and pharmacy operations |
A tailored compliance checklist will be provided based on the product classification and license type.
CDSCO approval is a regulatory authorization required for importing, manufacturing, and selling medical devices, pharmaceuticals, and certain cosmetics in India.
Manufacturers, importers, distributors, and retailers dealing with regulated healthcare products.
Medical devices, diagnostic equipment, surgical instruments, pharmaceuticals, and regulated cosmetics.
Yes. Regulated medical devices must obtain CDSCO approval before import or sale in India.
It ensures legal compliance, product safety, and authorization to sell healthcare products in the Indian market.
Find clear answers to common questions about CDSCO Licence. Our FAQs are designed to help businesses understand processes, timelines, and approvals with confidence.
