Schedule 2 Ivds

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 2 of the Medical Devices Rules 2017 specifies classification and regulatory requirements for in vitro diagnostic devices (IVDs). Key areas covered include: device categorization by risk level, pre-market approval pathways, quality management system requirements, labelling and packaging standards, and post-market surveillance obligations. IVDs are classified into three risk-based categories (A, B, and C) based on their intended use and risk to public health. Classification determines the regulatory pathway, with Category A devices subject to general controls, Category B devices requiring technical documentation and quality management compliance, and Category C devices requiring full pre-market approval. Approval timelines and documentation complexity increase with risk classification.

IVDs are classified into three categories: Category A (general control devices with minimal risk), Category B (devices requiring regulatory control), and Category C (high-risk devices requiring pre-market approval). Each category has distinct documentation requirements, with Category A devices subject to general controls, Category B devices requiring technical documentation and quality management system compliance, and Category C devices requiring full pre-market approval from CDSCO with detailed clinical evidence and manufacturing quality assurance.