Chapter I Preliminary

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

Key topics in Chapter I include: definitions of medical devices and related terms, scope of the rules, applicability to manufacturers, importers, and distributors, and establishment of regulatory authority responsibilities. Key definitions include 'medical device', 'manufacture', 'import', 'clinical investigation', and 'notified device'.