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.

Importers must maintain records of imported devices and facilitate inspection by CDSCO or authorized personnel. CDSCO may conduct random sampling and testing of imported devices post-clearance. Importers are responsible for ensuring traceability of imported devices in the supply chain and maintaining documentation for at least the device shelf-life or 5 years, whichever is longer.