{
  "id": 3028192,
  "title": "Govt eases medical device rules, speeds access to EU-approved products",
  "url": "https://urgent.news/2026/08/24/govt-eases-medical-device-rules-speeds-access-to-eu-approved-products",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-08-24T13:34:55.000Z",
  "source": {
    "name": "Live Mint",
    "slug": "live-mint",
    "url": "https://www.livemint.com/news/india/centre-amends-medical-device-rules-to-promote-ease-of-doing-business-adds-eu-for-trial-waivers-11787568139423.html"
  },
  "original_language": "en",
  "account": "The Indian government has made changes to medical device licensing rules to speed up access to EU-approved products and reduce compliance costs. The amendments to the Medical Devices Rules of 2017 eliminate the need for manufacturers outsourcing sterilization to obtain a separate \"loan licence\" if the sterilization facility already holds a valid licence. After a six-month transition period, companies must simply print the sterilization facility's licence number on the product label. The government has also added the European Union to its list of recognized regulatory jurisdictions, allowing EU-approved medical devices to gain faster access to India without undergoing local clinical investigations. This move is aimed at reducing paperwork, shortening market entry timelines, and cutting compliance costs for the medical device sector.",
  "summary": "Amendments to India's medical devices rules allow manufacturers to outsource sterilization without obtaining a separate loan licence if the third-party facility is already licensed.",
  "key_points": [
    "Indian government eases medical device licensing rules.",
    "Eliminates need for separate sterilization loan licence.",
    "EU-approved devices gain faster access to India."
  ],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}