Chapter Iii Import

This page summarises the key rules in this chapter of the Medical Devices Rules 2017 and links to the relevant primary source.

Official source: MDR 2017 — CDSCO

Chapter III governs the import of medical devices and requires importers to obtain import licenses from CDSCO. Key requirements include submission of import license applications, manufacturing facility inspection certificates, quality control and testing data, and compliance with labeling requirements in Hindi and English.