Updated on September 16, 2025 01:18:50 PM
CDSCO, India's National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices. CDSCO Test License is issued by DCGI under Central Drugs Standard Control Organisation.
CDSCO Test License for Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the drugs, medical devices and pharmaceuticals and cosmetics.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conduct of clinical trials, laying down the standards for drugs in the country and coordination of activities of state drug control organization by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
The CDSCO grants licenses for the Medical Devices testing, import or manufacturing after carefully evaluating each application. It is granted for the purpose of import, sell and distribution of Medical Devices working under government regulations to be followed to remove any hindrances.
CDSCO registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the medical devices, cosmetics, drugs, pharmaceuticals and cosmetics.
The selection of applications varies according to the device type, risk state of the drug, applicant characteristics, operations and home country approval by following all the government regulations.
Procedure to obtain CDSCO Test License for Medical Devices is as follows;
Visit the official website of CDSCO, Sign Up in the ‘SUGAM’ Portal for the registration application.
Fill all the necessary details in the form. The form is divided into two parts, the applicant needs to fill all his/her personal and organizational details
Required documents are mandatory to submit for the verification process for authorizing the CDSCO Test License.
Click on the verification link sent to the registered email Id to activate your account in the ‘SUGAM’ portal for the CDSCO Test License.
After the confirmation, the registration application will be sent to the concerned authority for the approval of the license
If the application got approved by the CDSCO officials, an email of approval will be sent to the registered email Id, vice versa for the case of rejection.
CDSCO Test License provides several benefits as:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Note: The aformentioned Fees is exclusive of GST.
Documents required in CDSCO Test License for Medical Devices are as follows:
CDSCO stands for Central Drugs Standard Control Organisation which grants license for the device testing, import or manufacturing after carefully evaluating each application. The application for registration Certificate and Import License is made under the Act to the licensing authority.
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Frequently Asked Questions
CDSCO is India's National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
DCGI,Drug Controller General of India regulates Pharmaceuticals and Medical Devices under CDSCO.
Signing up for the application,fill up the details,documentation,verification of the registration,approval from the authority,
Under Drugs & Cosmetics ACt 1940, and rules 1945.
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