{
  "id": 3004046,
  "title": "Govt ends loan licensing requirement for outsourced medical device sterilisation",
  "url": "https://urgent.news/2026/08/24/govt-ends-loan-licensing-requirement-for-outsourced-medical-device",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-08-24T10:57:41.000Z",
  "source": {
    "name": "Hindustan Times",
    "slug": "hindustan-times",
    "url": "https://www.hindustantimes.com/india-news/govt-ends-loan-licensing-requirement-for-outsourced-medical-device-sterilisation-101787569062072.html"
  },
  "original_language": "en",
  "account": "The Union health and family welfare ministry has scrapped the need for a separate loan license for medical device manufacturers outsourcing sterilization of their products, as per the amended Medical Devices Rules, 2017. The move is aimed at promoting ease of doing business, simplifying regulatory processes, and enhancing transparency, according to the ministry. A statement from the ministry reveals that the amendment is designed to facilitate timely access to advanced medical technologies. Manufacturers must now simply mention the sterilization facility's license number on the medical device label. Previously, manufacturers had to obtain a separate loan license in cases of outsourced sterilization, even when the sterilization facility had a license under the Medical Devices Rules, 2017. The ministry's decision to amend Rule 44 comes after extensive stakeholder consultations to simplify regulatory compliance for medical device manufacturers utilizing outsourced sterilization facilities. The amendment eliminates the requirement for a separate loan licensing process, reducing duplication, administrative burden, compliance costs, and timelines. A six-month transition period has been granted for manufacturers to implement the new labelling requirement. The amendment expands the list of recognized stringent regulatory jurisdictions for waiver of clinical investigation requirements to include the European Union. The inclusion of the EU means devices approved in EU member countries will benefit from the waiver provisions, potentially accelerating patient access to advanced medical technologies.",
  "summary": "The government said it amended the Medical Devices Rules to promote ease of doing business and simplify regulatory processes",
  "key_points": [
    "Union health ministry ends separate loan license requirement for outsourced sterilization.",
    "Manufacturers to label sterilization facility's license number on medical devices.",
    "Six-month transition period granted for implementing new labelling requirement."
  ],
  "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."
}