Updated on November 10, 2025 05:35:36 PM
The Central Drugs Standard Control Organisation is the National Regulatory Authority of India, being the highly powerful organization in India. It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning. CDSCO is responsible for the approval of new drugs and granting of licenses under the Drugs and Cosmetics Rules, 1945.
IVD is an In Vitro Diagnostics Medical Device that is used to test human samples. In-Vitro Diagnostics (IVDs) are tests that can identify diseases, disorders, and infections.
In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.
Manufacturing, importing and selling of IVD Lab Kits are labeled as Drugs in India. CDSCO Registration for IVD Lab Kits is a process of obtaining a manufacturing license for IVD Medical Devices by the manufactures to perform certain activities as Manufacture, Import, Clinical Performance, Sale and Distribution of IVD Medical Devices or Lab Kits in India.
IVD Medical Devices shall be classified into different classes based on their risk levels as:-
Process to do CDSCO Registration for IVD Lab Kits can be seen as follows:
You need to visit the official website of CDSCO, then you have to apply on the registration portal which is “SUGAM”. Click on the ‘SIGN UP HERE’ option to apply for the registration.
Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.
Complete the application process by submitting the required documents for the verification process
A Confirmation link will be sent to the registered email Id to verify the registration. To activate your account on the SUGAM portal, you need to click on the confirmation link.
Once the Confirmation link is clicked, the application for registration will be sent to the concerned authority, to the CDSCO officials for approval of the license.
After completing the whole procedure, your documents will undergo a verification process to see any secrecy. If the officer gets satisfied with the whole document procedure then your application will be approved.
CDSCO Medical Device Registration for IVD Lab Kits has several
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
Documents required in CDSCO Registration for IVD Lab Kits are as follows:
CDSCO is continuously striving to bring out transparency, accountability and uniformity in its service in order to ensure safety, efficiency and quality of the Medical Products and Kits which are manufactured, imported and distributed in the country. It is mandatory for the manufacturers to obtain a manufacture license for IVD Lab Kits in order to Manufacture, Import, Clinical Performance, Sale and Distribution of IVD Medical Devices or Lab Kits in India.
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Frequently Asked Questions
IVDs are In Vitro Diagnostics Medical Devices that are used to test human samples.
CDSCO Registration is a process of obtaining an approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals,Medical Devices and Cosmetics.
CDSCO registration Portal, Filling up the details, Submitting the documents, Call for Confirmation, Approval from the Authority, Issuance of the license.
Yes, IVD lab kits are classified under specific regulatory categories and require their own CDSCO registration. For other devices like digital thermometers, you can refer to the CDSCO Medical Device Registration for Digital Thermometer for separate compliance requirements.
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