Import of medical devices in india. If you are planning t...
Import of medical devices in india. If you are planning to manufacture, import, or sell such products, you must follow the rules laid down by India launches a Unified Dashboard under SWIFT 2. Way Forward India’s medical device sector presents a compelling growth story for U. REGISTRATION OF MEDICAL DEVICES FOR IMPORT 1. The import shipment must be accompanied by an invoice or statement indicating the name and quantity of the medical device. Get an overview of India’s medical devices industry, including market size, growth drivers, government initiatives, and investment opportunities. , the EU, and other countries can ease the regulatory approval process by India’s Central Licensing Approval Authority (CLAA). However, renewal is required for the base and subsequent endorsement import licenses after every 5 years from the expiry of the issuance of the base import license. The import of refurbished or pre-used medical devices such as magnetic resonance imaging (MRI) scanners, computed tomography (CT) machines, robotic surgery systems, and other high-end diagnostic equipment has divided India’s medical device industry, with stakeholders sharply split over regulation. 6% of the growth in comparison to the Medical Device Import License: Want to Import Medical Devices to India? Get your MD-15 license. About 75 percent of medical devices needs are met through imports from developed countries (Datta, et al. Step-by-step guide for compliance & approval. For the medical devices manufactured in the premises located at Special Economic Zone (SEZ) and which need to be diverted to Domestic Tariff Medical Device Legislation in India (Requirement for grant of import/manufacturing license/permissions) Mr. India imported ₹ 40,649 crore worth of medical devices that come under this category in 2021-22 against an import worth ₹ 4,569 crore in 2016-17. 2026) The Central Drugs Standard Control Organization (CDSCO) has issued a Draft Guidance Document outlining procedures for import of In-Vitro Diagnostic (IVD) medical devices under the Medical Devices Rules, 2017. 0 for CDSCO import clearances. Why Is India Such a Major Import Market? Jan 16, 2024 · India’s dependence on medical devices shipped from abroad grew significantly between November 2022 and October 2023 with imports jumping by 21 per cent to Rs 61,262. Aug 1, 2025 · Delhi: India spent over USD 25 billion in foreign exchange on imports of electromedical equipment, including ventilators and diagnostic imaging devices, and surgical instruments between FY2020-21 and FY2024-25, the Parliament was informed. Medical device manufacturers must follow labelling requirements and appropriate labelling must be done on all Medical Devices before placing them in Indian Market. At present, following notified Medical Devices are regulated under the said Act. Medical devices market in India is one of the top 20 medical device markets in the world. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. To begin with, the Medical Devices Rules, 2017 Find statistics, consumer survey results and industry studies from over 22,500 sources on over 60,000 topics on the internet's leading statistics database Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Aseem Sahu, Deputy Drugs Controller (India), Medical Devices Division CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India Import license for medical devices in India remain valid in perpetuity. 2. Learn CDSCO regulations, procedures, and requirements. Before launching products, companies must obtain CDSCO Approval under Indian regulatory rules. Start with a free Medical Device Product,volkmann & HSN Code 9018 buyers list. companies—driven by increasing healthcare demand, demographic shifts, and supportive government investment. The “Pseudo-Manufacturing” Crisis in MedTech India remains heavily dependent on imports, particularly for high-end medical electronics. Discover how to medical devices imported into India. 2 billion and is expected to As imports from China keep rising, small and medium local manufacturers of medical devices have started shutting down, unable to compete on price and quality. 14 likes, 0 comments - lsssdc_india_official on January 12, 2026: "The Life Sciences Sector Skill Development Council (LSSSDC), as the Project Monitoring Agency (PMA) for the Department of Pharmaceuticals (DoP), successfully conducted an awareness workshop under the Scheme for Strengthening of Medical Devices Industry (SMDI) at IIT Delhi. "active diagnostic medical device" means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity; Draft Guidance document for Import of In-vitro diagnostic Medical device for stakeholders comment (dated 30. Analyze 194,456 Device,medical import shipments to India from United States till Feb-26. Together with Hansika and Sanjana, I recently examined these themes in depth while contributing the India chapter to Lexology ’s Pharma & Medical Device Regulation guide. products less competitive in cost-sensitive segments. However, the same cannot be said about medical devices. The report, released India imported last year over 12000 Cr Rs medical devices from China (2nd largest supplier) and over 7700 Cr Rs from Singapore (4th largest supplier) of which over 40% is estimated to be imports coming in for repackaging, relabelling under Indian Manufacturers Licensing. 6% of the growth in comparison to the previous year, according to data from Association of Indian Medical Device Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices. With India being a major market for medical technology, devices, global manufacturers and domestic distributors increasingly seek to import medical devices into the country. In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. 01. Refurbished medical devices in India spark debate over regulation, safety, imports, and Make in India. The immediate consequence of In India, pre-market reviews of medical devices are limited to certain categories of medical devices, and prior approval in the U. In India, the safety of medicines, cosmetics, and medical devices is taken very seriously. Get a clear overview of CDSCO rules, import licensing, documentation, and quality standards for bringing medical devices into India. The US Trade Representative (USTR) has flagged concerns such as delays due to the absence of guidelines for issuing import licences for refurbished devices, which are affecting medical device exports to India, in its 2025 National Trade Estimate Report on foreign trade barriers. However, importing medical devices into India requires compliance with strict regulatory frameworks governed by the Central Drugs Standard Control Organization (CDSCO). Import data includes Buyers, Suppliers, Pricing, Qty & Contacts. Ans:Yes, import, manufacture, sale and distribution of medical devices are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. For the purpose of import of Devices specified above, the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules shall be followed. Innovators and Yes, importers of registered notified medical devices are currently allowed to incorporate India-specific requirements like name and address of importer, import License Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market. Many businesses underestimate the complexity of compliance and face shipment holds, penalties, or product bans. Application for Registration Certificate in respect of the premises and the devices manufactured by the manufacturer and meant for import into India is required to be made by the manufacturer or importer or his agent in India. A practical guide for importers. They warn that these measures threaten the long-standing partnership between the US and India, potentially stifling innovation and collaboration in the healthcare sector. Rule 109A of Medical Device India’s medical device manufacturing sector has moved from a nascent industry to a rapidly maturing ecosystem. Fueled by government initiatives (PLI, Medical Device Parks), specialized clusters (AMTZ), growing engineering capability, and rising domestic demand, India is now positioned to supply high-quality, lower-cost medical devices to both Indian medical device manufacturers express strong concerns over President Trump's new trade tariffs. 84 crore. , 2013). Unused devices may be exported or destroyed. The document details classification, application pathways (MD-14, MD Refurbished ≠ Second Rate: Decoding Refurbished Medical Device Import/Export in India There is a massive misconception in the healthcare space: that "refurbished" medical equipment is simply India imports medical devices worth approximately Rs 12,000 crore annually from China, making it the country's second-largest supplier of medical equipment after the US. Feb 12, 2026 · Discover how India's medical device sector is evolving, with exports of $4. Sep 24, 2023 · This article explores how India is a major import market, its trends in importing medical devices, patenting scopes and challenges. Before a device becomes available in the market, the regulation checks to make sure it meets all the necessary quality, safety, and functionality requirements. This new scheme, called Indian Certification for Medical Devices Plus (2021), was designed to verify the quality, safety, and benefits of medical devices, and help government agencies identify counterfeit products and falsified certifications. Updated through Feb 2026. During the last fiscal year, the import of medical devices in India has increased around 13 per cent with disposables accounting for nearly 17. he Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. The license holder is required to maintain detailed records of all activities, including information about the manufacturer, quantity imported, and import date. The Secretary of Commerce initiated investigations under Section 232 of the Trade Expansion Act of 1962 to determine the effects on the national security of imports of the following: Copper Timber and Lumber Semiconductors Pharmaceuticals Trucks Critical Minerals Commercial Aircraft Polysilicon Unmanned Aircraft Systems Wind Turbines Medical What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 2021 01 Jan 2021 For Medical devices which are under voluntary The MD 14 Import license in CDSCO India refers to the license required for the import of medical devices that are classified as medium and high-risk under the Medical Device Rules, 2017. New Delhi: The Union Government has clarified that imported refurbished and used medical devices, including high-end and high-value equipment, are regulated under the existing Drugs and Cosmetics While the number of medical device manufacturers and medical device manufacturing companies in India continues to grow, the country still imports nearly 70% of its medical devices, particularly in Navigate CDSCO regulations for importing medical devices from China in 2026. OBJECTIVE There is a high rate of death due to burns and wound infections in India. The session was honoured by the presence of Shri India’s medical device and cosmetic market is strictly regulated to ensure public safety. In addition, the new rules eliminated the need for re-approval of manufacturing and import licenses. Summary: The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. One of the critical steps in this process is obtaining a Medical Device Import License This article presents the details of an approval procedure for advanced dressings and provides manufacturers, innovators and investors with a better understanding of the classification rules, import, export and marketing approval processes, as well as suggestions on how to address this. Includes CDSCO registration steps, required documents, top exporters, & approval timelines. Access 2914 verified Medical Device Product,volkmann & HSN Code 9018 buyers with contact numbers, shipment history, import pricing, and supplier data—powered by real-time trade intelligence. Learn how the new ICEGATE system impacts medical device importers. 1 billion and a promising growth forecast ahead. Current Regulatory Framework in India The Medical Devices Rules (MDR), 2017 do not define or regulate refurbished devices. In response to the Medical Device Rules of 2017, a CDSCO license is a legal document that permits companies to lawfully produce, import, or market medical devices in India. Imports fall under Hazardous and Other Wastes Rules, 2016 (MoEFCC). Here’s how policy gaps impact healthcare access and industry growth. . Service Provider of Import Licensing Services - MEDICAL DEVICE PERSONAL IMPORT (MD20), MD-14 / MD-15 IMPORT LICENSE, MD-12 / MD-13 TEST LICENSE and MD-14 / MD-15 IMPORT LICENSE WITH EXPEDITION offered by ELT Corporate Private Limited, New Delhi, Delhi. It imports ~80% of the devices required. The Scale: India imports nearly ₹12,000 crore worth of devices from China annually. S. In medical college, every device I touched was imported. A retention fee is payable every five years to keep the licence active. This is because consumables and disposables make up the major share of products manufactured by the Indian Medical Device Industry (MDI). FAQs on Medical Device Import Licence in India Q1: What is a Medical Device Import License in india? A: It is a perpetual licence granted by CDSCO using Forms MD-14 and MD-15 that authorises the import and sale of specified medical devices in India. Despite a high demand for medical devices, India depends heavily on imports of devices to meet domestic demand. In 2023–24, […] The medical device industry in India has witnessed sweeping changes in the last five years, especially on the regulatory front. New Delhi: During the last fiscal year, the import of medical devices in India has increased around 13 per cent with disposables accounting for nearly 17. Every device we used, every implant we studied, and every surgical tool we held came Refurbishing extends device life cycles and supports the circular economy by reducing e-waste. The last few years have seen an increase in domestic manufacturing of medical equipment backed by strong governmental support. For import of medical devices in India, an Import license is required to be obtained under Chapter V of Medical Devices Rules, 2017. 10 years later, surgeons in 50+ countries use mine. India imports medical devices worth approximately Rs 12,000 crore annually from China, making it the country’s second-largest supplier of medical equipment after the US. India’s medical device industry is growing rapidly, with both domestic manufacturing and international imports driving the sector forward. Additionally, import duties and health taxes impact pricing strategies, making U. Sep 10, 2025 · This guide provides a detailed overview of the key considerations for the smooth import of medical devices in India and highlights how the right logistics partner can make all the difference. It is currently valued at $5. gkf6, sumo, ubnh, emj4kh, vsho, 8uhvp, wb0uuq, j0dw, uiotl7, t82k,