Crucial document required for the license to import InVitro diagnostic devices:

In accordance with part II of the IV schedule of the New Medical Rules of 2017, the applicant must provide the different documents that are needed for import registration.

• Covering Letter.
It is required of the applicant to specify if the application is for registration or re-registration.
A list of required documents should also be included in the letter.
An authorized signatory must properly sign all required documentation.
Specifics of the Imported Goods.
Specifics of the production location.
• Attachment of Regulatory and Other Required Documents in accordance with Form MD 14
• Power of Attorney.
• The ISO13485 Certification.
• Challan TR 6.
• GMP Certificate.
• CE Design Certificate.
• Confirmation Statement.
• PMS analysis.
• Certificate of Plant Registration and Business License.
• Report on Audit.
• The Indian Agent's Constitutional Details.
• A current license from the manufacturer or wholesaler approved in India to register the import of InVitro diagnostic kits.
• A quality certificate from an international manufacturer confirming the product's excellence.
• A no-cost transaction It is necessary to present the Certificate FSC with the application. The FSC is a crucial document that guarantees that proposed imports of InVitro devices are sold freely in the exporting nation and that export and trade liberalization are approved.
• Certificate of Batch Release.
• Comprehensive Test Report.