The regulatory approval process for medical devices in India is governed by the Medical Devices Rules (MDR), 2017, under the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. Below is a concise overview of the process: 1. Device Classification 2. Registration on SUGAM Portal 3. Quality Management System […]
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In India, medical device registration, as governed by the Medical Devices Rules (MDR), 2017 under the Central Drugs Standard Control Organization (CDSCO), results in the issuance of licenses that are valid for 5 years from the date of issuance. This applies to: Renewal Process Additional Notes For expert assistance with renewals or registration, contact Satish
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Importing medical devices to India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017 (MDR-2017), as amended. These rules classify devices by risk level (Class A: low risk; B: low-moderate; C: moderate-high; D: high) and require registration and licensing for most imports. Since October 2023, all Class A
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The MD-41 and MD-42 licenses are critical components of India’s medical device regulatory framework, introduced under the Medical Devices Rules (MDR), 2017, and amended by the Medical Devices (Fifth Amendment) Rules, 2022, effective from September 30, 2022. These licenses, governed by the Central Drugs Standard Control Organization (CDSCO) and issued by State Licensing Authorities, are
What is MD 41 and MD 42 licenses 2026? full detiails Read More »
Overview of EU MDR Compliance for Importers in 2026 Under the Medical Device Regulation (EU) 2017/745 (MDR), importers act as the first economic operator in the EU supply chain and bear significant responsibility for ensuring medical devices placed on the market are safe, perform as intended, and fully comply with regulatory requirements. Article 13 outlines
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