Medical Device Import in India Hits Record Roadblocks in 2025 – Over 12,000 Consignments Stuck!New Delhi, November 16: Importing life-saving medical devices into India has turned into a nightmare for thousands of companies this year. Medical device import India, CDSCO registration hurdles, customs clearance delay, import licence India delays and strict MDR 2017 compliance are […]
Are You Looking to Import Medical Devices into India? India’s healthcare industry is growing rapidly, and the demand for high-quality medical devices is at an all-time high. Whether you’re a hospital, distributor, clinic, or healthcare startup, importing medical devices from global markets can give you a strong competitive edge. But the process isn’t simple —
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The term “TAC approval” in the context of India primarily refers to the Type Approval Certificate (TAC), a mandatory certification for automotive products under the Central Motor Vehicles Rules (CMVR), 1989, enforced by the Ministry of Road Transport and Highways (MoRTH). This certification ensures that vehicles and automotive components meet stringent technical, safety, and regulatory
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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
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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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