Pharma, Drug And Healthcare

Product Details:

License (Medical Devices and In-Vitro Medical Devices) – Import

 

For medical device mentioned in Annexure of eighth schedule which are notified as per Medical Devices Rule 2017. Means that medical devices importer shall be granted import license from CDSCO before import such medical devices.

For import of medical devices following form available for application and approval of licenses.

1.      Application for issue of import licence to import medical device in MD-14 and Licence to Import Medical Device in MD-15.

2.      Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-16 and Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-17.

3.      Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients in MD-18 and Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients in MD-19.

4.      Application for permission to import small quantity of medical devices for personal use in MD-20 and Permission to import of small quantity of medical devices for personal use in MD-21.

5.      Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-26 and Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-27.

6.      Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-28 and Permission to Import or Manufacture New In Vitro Diagnostic Medical Device in MD-29.

Consultancy Charges will be provide separately based on products.

Procedure for License to Import of Medical Devices (Import - CDSCO)

1.      Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form. For document Checklist please refer requisite form no. eg. MD-14, MD-16 etc.

2.      User id Creation – Crate user id on Sugam portal of CDSCO with required documents.

3.      Application to CDSCO – After verification of prepared documents, we will make an application to CDSCO. After application CDSCO official will review application and raising query if any.

4.      Query reply – If any addition document required or submitted document is not accepted by Central Licensing Authority. So we need to submit revised documents as per query.

5.      Grant of License – After verification of documents Central Licensing Authority shall grant import license as per application form.

Timeline of Process

After application to CDSCO – 1-2  Months.

Shamkris Global Group is a leader in providing comprehensive, value-added consultancy services that expertly navigate businesses through the complex landscape of regulatory licensing and certification services. We are committed to facilitating the smooth acquisition of regulatory licenses and certifications that are tailored to your unique needs.

 

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