The Central Drug Standard Control Organisation (CDSCO) has decided to initiate an online portal for Registration and import license application for the medical device. This online registration / submission of medical devices portal should start from March, in which we can apply, track the status of application, document submitted, license to import the medical device into India through a application reference number. The portal is handled by SUGAM which is in tie up with the Union health ministry’s e-governance  initiative.

Presently the portal has started working on granting license to import the drugs (registration certificate for drugs in India) and import license for the drugs industry. It will provide the benefits shortly to the medical device industry of India for granting of registration certificate and renewal of the license for medical devices. The eligible applicants are the importer, corporate, Indian Authorized Agents, foreign enterprise holding Indian subsidiary and manufacturing unit can also apply for the licence.  You could find the important licenses and forms to keep in mind in our blog section.

Drug Controller General India (DCGI) Dr G N Singh said that, “The portal will be launched soon and the start up will take the e-governance to a new level. By which the stakeholders and patients get their license and medicines without any delay. Regulatory requirements need to be set to minimal standards so that there wont be any stopping factor in the industry to affect any of the work hence the decision to launch the online portal was taken”.

Applicants should register themselves in the portal to login with valid credentials and can apply for the license. The portal has a fresh user interface to submit user applications, supporting documents and can communicate to the queries of the CDSCO officials.