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CDSCO To Grant Online Registration
Certificate, Renewal Of Licence For Import Of Medical Device Soon
The Central Drug Standard Control Organisation (CDSCO) is
planning to launch an online portal for licensing the import of medical device
under SUGAM, an online solution for submission, application and grant of
permission for the import of drugs, in compliance with Union health ministry’s
initiative of e-governance.
At present the portal only provides benefit for the grant of
registration certificates for import of drugs or import license of drugs. Soon
the medical device industry can also avail the benefit of online grant of
registration certificate and renewal of licence for the import of medical
devices.
Dr. G N Singh, Drug Controller General India (DCGI) says, “We
will be launching the portal soon and this initiative will put the e-governance
in place. So that the stakeholders get the licence in time & benefit of the
devices are given to the patients on time. We want to reduce the regulatory
requirement to the min. There should not be any regulatory hindrance for the
industry which is doing so well. So we felt the need of launching the online
portal for the medical device sector.”
Online licensing system provides an opportunity for user to
apply for licenses through online licensing system. It also provides an option
to track the status of application online through an application reference
number provided by the system during the submission of application.
User can register themselves online for the user name and
password and can access the portal by logging through valid login credentials to
apply for licenses. An online interface for user to submit fresh applications,
upload supporting documents, respond to queries from CDSCO officials. The user
account lists out all the licenses held by it through the country, licenses
issued, suspended and cancelled, details of the facilities for manufacturing at
each location, import licenses details, details of the technical staff working
at each facility etc.
The applicants who can apply for the licence includes
importer, Indian agent, corporate, foreign enterprise holding Indian subsidiary
and manufacturing unit.
( Ref:
http://pharmabiz.com/ArticleDetails.aspx?aid=93504&sid=1 )
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