The U.S. Food and Drug Administration authorized a higher number of medical devices in the first half of 2026 compared with the same period in 2025. Review timelines for original premarket approvals lengthened substantially during this period. The trend emerges as the agency prepares for a public meeting on August 5, 2026, regarding future medical […]
FDA Authorizes More Medical Devices in 2026 Amid Longer Reviews Read More »
What is CDSCO? If you are planning to import, manufacture, or sell medical devices in India, understanding CDSCO (Central Drugs Standard Control Organisation) is the first and most important step. CDSCO is India’s national regulatory authority responsible for regulating drugs, cosmetics, medical devices, and clinical investigations. Similar in role to the U.S. FDA, CDSCO ensures
What is CDSCO 2026? | A Complete Guide for Medical Device Manufacturers in India? Read More »
New Delhi — Importers and manufacturers navigating the Indian medical device market must submit Form MD-14 to the Central Drugs Standard Control Organization for registration and import approval. The process, governed by the Medical Devices Rules, 2017, ensures safety and quality standards. Recent updates in 2026 have streamlined online submissions while maintaining strict compliance requirements.
Form MD-14 Guide: Import Medical Devices in India 2026 Read More »
Form MD-26 is used under the Medical Devices Rules, 2017 for permission to import or manufacture new medical devices or those without a predicate device in India. It leads to Form MD-27 approval. Unlike Form MD-14 (for reference country approved devices), MD-26 involves stricter scrutiny for novel or unapproved devices. Who Needs Form MD-26 Key
Form MD-26 Requirements: New Medical Device Import/Manufacturing Permission Read More »
The CDSCO SUGAM portal (cdscoonline.gov.in) is the official online platform for submitting regulatory applications for drugs, medical devices, and related approvals in India. It streamlines licensing, imports, and permissions under the Drugs and Cosmetics Act. Step 1: Registration on SUGAM Portal Once approved, log in with your credentials to access the dashboard. Step 2: Update
SUGAM Portal Submission Steps for CDSCO Applications 2026 Read More »
Form MD-14 is the standard application for grant of import license under the Medical Devices Rules, 2017. It replaced older fragmented processes with a centralized digital system managed by CDSCO in New Delhi. The form requires details about the importer, foreign manufacturer, device specifications, and supporting documents from the country of origin. Successful approval results
CDSCO Form MD-14: Guide to Medical Device Import License Read More »
New Delhi — Importers of medical devices must secure a CDSCO Import Medical Device Licence before bringing products into India. The Central Drugs Standard Control Organization oversees the process through its SUGAM online portal. As of 2026, all classes of devices require proper licensing for legal market entry. The Medical Devices Rules, 2017 govern these
CDSCO Import Medical Device Licence: 2026 Guide Read More »
India’s medical device import framework has shifted significantly in 2026 under the Central Drugs Standard Control Organisation (CDSCO). The transition from voluntary to mandatory compliance is finalized, and stricter oversight has been implemented across the board. The primary updates shaping medical device imports in 2026 highlight the core changes foreign manufacturers and Indian importers must
BREAKING: Ends Voluntary Registration and universal licensing 2026 Read More »
New Delhi — The Central Drugs Standard Control Organization issued a notification on July 10, 2026, updating procedures for importing medical devices into India. The changes apply mainly to Class A and Class B devices and introduce a revised document checklist along with faster scrutiny timelines. Importers can now submit applications through an upgraded online
CDSCO Updates Medical Device Import Rules 2026 Read More »
What is the CDSCO Single Window Portal? The National Single Window System (NSWS) is the Government of India’s unified digital platform for business approvals. For medical devices, CDSCO has been migrating several services to this portal since January 2024. It aims to provide a single interface for submitting applications, tracking status, and obtaining approvals instead
CDSCO Single Window Portal (NSWS) – Complete Overview Read More »
