The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority responsible for medical devices and pharmaceutical aspects under the Ministry of Health and Family Welfare and the Directorate General of Health Services. The organisation is responsible for the approval and regulation of the new drugs and clinical trials of the country under the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. However, you need to obtain CDSCO registration in India before you are able to deal with these items. What is the applicability of CDSCO registration, and who shall register? Let’s understand the intricacies of CDSCO registration in India.
The Purpose of CDSCO Registration
The CDSCO registration requirement may arise due to multiple reasons, including but not limited to the following:
- Cosmetics Registration;
- Blood Bank Registration;
- Dual Use NOC (Trader);
- Test License;
- Import or Manufacture of Drugs;
- BA or BE Approved Sites;
- Formulation of Research and Development Organisation;
- Ethics Committee Registration;
- Export NOC (Zone);
- Sponsors (BA or BE and CT);
- Blood Product Registration.
Who Can Obtain CDSCO Registration \ Medical Device Registration in India?
The following are the different persons who can obtain CDSCO registration in India:
- Indian agents
- Foreign enterprises having Indian subsidiary
Licensing Authorities Under CDSCO
There are two licensing authorities for the grant of CDSCO registration online. These include:
- State Licensing Authority (SLA): The SLA is responsible for issuing the CDSCO manufacturing or wholesale license for the IVDs and medical devices that fall under Class A & B.
- Central Licensing Authorities: The CLA is responsible for issuing the CDSCO manufacturing or wholesale license for the IVDs and medical devices that fall under Class C & D. It is also responsible for the grant of import licenses for cosmetics in India.
Benefits of CDSCO Registration in India
Following are some of the significant benefits of CDSCO registration in India:
- CDSCO registration in India enhances the brand image and is significant in gaining customer trust. This directly enables registered persons to gain a higher market share.
- It is significant in ensuring regulatory compliance. Not obtaining CDSCO registration online despite being liable to do so can attract significant fines and penalties.
- It guarantees the safety and quality of the products and devices and thus, is critical for customer interest and protection.
- It allows you to tap the innovations and products in the global market and deliver the same in Indian markets.
Types of CDSCO Registrations in India
Following are some of the most prevalent types of CDSCO registrations in India:
- Medical Device Registration: Any person or business that is willing to manufacture medical devices in India needs to obtain medical device registration under CDSCO. The registration is granted by the SLA or CLA depending upon the risk classification of the medical devices. These devices can be bifurcated into four classes:
- Class A: Medical devices posing lower risks, like sphygmomanometers and thermometers
- Class B: Medical devices posing low to medium risks, like suction cannulas and needles
- Class C: Medical devices posing medium to high risk, like joint implants and ventilators
- Class D: Medical devices posing high risks, like heart valves and pacemakers
- Medical Device Import License: If a person is willing to import notified medical devices to India, then such person is required to obtain a medical device import license. Such a person needs to appoint an authorised agent in India and submit the necessary certificates of approval like FDA approval, ISO or EN certification, CE certification etc.
- In-Vitro Diagnostic Device Manufacturing License: For manufacturing in-vitro diagnostic medical devices in India, a person needs to obtain an in-vitro diagnostic device manufacturing license in India. In-vitro devices basically include the reagents, kits, instruments and systems that are used for diagnosing health conditions and diseases. It also includes devices used for determining a person’s health in order to cure, prevent or treat any disease or sequelae.
- In-Vitro Diagnostic Device Import License: If a person is willing to import an in-vitro diagnostic device in India, then such a person needs an in-vitro diagnostic device import license. The application for the purposes of importing the in-vitro diagnostic devices can be filed through the CDSCO Sugam portal online. The CLA shall assess the application and decide on the grant or rejection thereof.
- Cosmetics Import License: For importing a cosmetics license, you need to obtain a cosmetics import license under CDSCO. Cosmetics basically include any substance or material that can be sprayed, scrubbed, poured or introduced into the human body for cleansing, beautifying or altering the appearance. It also includes any article that is a part of the cosmetic products.
How to Obtain CDSCO Registration?
To obtain CDSCO registration in India, you need to make an application online by signing up on the Sugam CDSCO portal. After specifying the registration purpose and entering all the necessary details, you shall submit the registration online. Your application will be sent to the CDSCO for approval. The intimation of approval or rejection of your CDSCO registration application will be sent to your registered email ID.
Following are the complete details regarding the CDSCO registration in India. In case you need any assistance with CDSCO registration online, feel free to contact the ASC Group.