CDCSO Certification

Medical Devices entering India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, and coordination of the activity of State Drug Control Organizations.

As per the new Guidance of CDSCO, suspension and cancellation of the Class A & B medical devices may happen if importer fails to meet the deadline specified by CDSCO. CDSCO has set a complete procedure for granting licenses for medical devices imported in the country. This procedure is applicable when we import medical devices from other countries to India. However, they need to be classified according to CDSCO notified devices list. Earlier manufacturers were able to sell their medical devices in India without following any specific rules and regulations but from 2006, medical devices entering India need to follow specific import guidelines set by CDSCO.

Following are some vital documents required at the time of CDSCO Cosmetic Import Registration:

1. Covering Letter: Purpose (Fresh/Endorsement of Products or Pack Size or Manufacturing site or Additional Sourcing Location or Re-Registration) must be clearly mentioned along with the information of earlier issued Import Registration Certificate (if any) and product or product category (whether registered or not).

2. Part-1 Of Second Schedule: Details & undertaking required to be provided by the manufacturer or his authorised distributor or importer, or agent with the application form for Import Registration Certificate. The format should be properly filled in for each application in Form COS-1.

Following is the step by step procedure for CDSCO Cosmetic Import Registration in India:

Step 1:  Determination Of Cosmetics Classification: When a manufacturer decides to register their products in India, then the manufacturer must check the Gazette Notification of CDSCO prior to making a final determination of a device’s regulatory status & classification.

Step 2:  Appointment Of An Indian Agent: The manufacturer should appoint an authorised Indian agent to interact with the CDSCO. The agent will be granted a Power of Attorney to assist in cosmetic approvals and manage registration & importation in India.

Step 3:  Fill Out The Application Form For CDSCO Cosmetic Import Registration: After appointing an agent, the importer or manufacturer of cosmetics shall be required to submit the Registration Form along with all the documents and prescribed fee on the CDSCO website to the Drug Controller General Of India (DGCI) by simply logging on to the online website of CDSCO and signing into the website.

Step 4:  Issuance Of CDSCO Cosmetic Import Registration Certificate: Once the application form along with documents & fee is submitted on the website of CDSCO, the DGCI Registration Authority may send a query via an inquiry letter to the manufacturer or from the certified representative of the importer. Once the authority is fully satisfied with the application, then they may issue a Cosmetic Import License.

A licence is Valid for a period of 5 years from the date on which it is granted or renewed.