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India explains requirements for importing non-critical IVDs

This article was originally published in Clinica

Executive Summary

The Indian Central Drugs Standard Control Organization (CDSCO) has issued a checklist of documents that manufacturers of non-critical diagnostic kits and reagents can refer to when applying for an import licence to market their products in the country. The checklist provides guidance on the types of documents that manufacturers would have to submit and related procedures. It states, for example, that the original application (form 8) should be signed and stamped by the authorised signatory of the importer/Indian agent. The full checklist is available on the agency’s website at http://cdsco.nic.in/CHECKLIST%20FOR%20THE%20GRANT%20OF%20FORM%2010%20LICENSE%20FOR%20THE%20IMPORT%20OF%20NON-CRITICAL%20DIAGNOSTIC%20KITS.htm

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