ISI stands for Indian Standards Institution. ISI certification refers to the scheme under which Bureau of Indian Standards ( BIS ) grants ISI mark to Indian and Foreign manufacturers on the basis of the Indian Standard ( IS ) applicable on their product.
Advantages of ISI Certification
Who can Apply
All the Manufacturers, either Indian or foreign can apply for the licence.
In case of foreign manufacturer the licence will be granted in the name of manufacturer and it’s Authorized Indian Representative combined.
The Indian representative of the manufacturer must have a valid state drugs licence under Form 20-B/21-B or Form 41 as per the latest guidelines
Different Divisions of CDSCO
Divisions of CDSCO are as below:
1.) Medical device division ( Drugs )
4.) Clinical Trial on medical devices division
Vital Documents Required for CDSCO Registration
Documents that are required for CDSCO licence / registration completely depends of the type of application that has to be submitted i.e. they are different scheme-wise and product wise, but below are some basic documents that are to be submitted for an application of class B, C and D products for procurement of import / manufacturing licence:
You can reach our experts for complete checklist of documents required for FREE .!!
How does SunConsultants help you in CDSCO Registration ?
From collection of documents to getting the final registration / licence is an exhaustive and tedious procedure, and requires technical know-how and experience, this is exactly where Sun Consultants and Engineers come into the picture.
With over 7 years of experience in this field and after providing assistance to numerous manufacturers and importers we can help you in smoothening of this process, by complete hand-holding solution, right from the beginning of the procedure to the grant of registration/licence.
We are medical devices certification consultants based in Delhi and we assist our clients worldwide in obtaining the certifications required on medical devices in India on their variety of products.
Not only assistance in collection of documents, our experts can help you in preparation of the documents or providing with draft formats of those documents so that the application can be filed smoothly.
Timeline – Procedure
Though the timeline differs on the basis of the licence that has to be applied and the level off documentation that the Indian/Foreign manufacturer has, after submission of the application the import licence for medical devices with out assistance can be obtained in approx.6 weeks and after submission of documentation for the registration procedure we can get the registration withing the same day as that of application.
The licence is initially granted for 5 years and can be renewed after a certain time frame. There is no such validity of registration of Class-A products ( Non-measuring and Non-sterilized ) and other registrations