{
  "id": 2997387,
  "title": "Centre eases Medical Devices rules, adds EU to waiver list",
  "url": "https://urgent.news/2026/08/24/centre-eases-medical-devices-rules-adds-eu-to-waiver-list",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-08-24T10:14:28.000Z",
  "source": {
    "name": "ETHealthworld",
    "slug": "ethealthworld",
    "url": "https://health.economictimes.indiatimes.com/news/medical-devices/centre-eases-medical-devices-rules-adds-eu-to-waiver-list/133460822"
  },
  "original_language": "en",
  "account": "The Union Health Minister recently amended the Medical Devices Rules, 2017, dropping the requirement for a separate loan licence when medical devices are outsourced for sterilisation. This change aims to reduce duplication, administrative burden, compliance costs and timelines, especially for manufacturers without in-house sterilisation facilities. The ministry further added the European Union to the list of recognised stringent regulatory jurisdictions for waiving clinical investigation requirements for medical devices without predicate devices. This move will benefit eligible medical devices already approved in the EU, facilitating quicker patient access to advanced medical technologies in India. The amendment follows the signing of the India-EU Free Trade Agreement in January, which brings tariff cuts on European medical devices.",
  "summary": "According to the ministry, “Under the amended provisions, manufacturers outsourcing product sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilization activity”",
  "key_points": [],
  "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."
}