{
  "id": 18702996,
  "title": "Health gear firms set to be not left to own devices",
  "url": "https://urgent.news/2026/11/07/health-gear-firms-set-to-be-not-left-to-own-devices",
  "topic": "world",
  "section": "World",
  "published": "2026-11-07T11:07:53.000Z",
  "source": {
    "name": "RTHK English",
    "slug": "rthk-english",
    "url": "https://news.rthk.hk/rthk/en/component/k2/1876945-20261107.htm"
  },
  "original_language": "en",
  "account": "The Health Bureau in Hong Kong is working on a medical devices bill to be introduced next year, aiming to replace the current voluntary administrative regulatory regime. This new bill will adopt a dual-track regulatory model, focusing on both pre-market and post-market risk management for medical devices. The proposed registration system will classify medical devices based on risk levels, ensuring that items such as hypodermic needles, contact lenses, urine test strips, and blood glucose reagents meet safety and quality standards before being sold in Hong Kong. Local manufacturers, importers, and wholesalers will need to obtain licenses before supplying these products. Additionally, traders will be required to report any incidents related to medical devices that pose public health threats or result in serious health deterioration, and take necessary corrective actions as per the department's requirements. The ultimate goal is to strengthen regulatory oversight and prevent potential consequences of such incidents. Health services officials will discuss the legislative proposals in a meeting scheduled for Friday.",
  "summary": "The Health Bureau said it is striving to introduce a medical devices bill next year to replace the current voluntary administrative regulatory regime. In a paper submitted to the Legislative Council, it said a dual-track regulatory model covering both pre-market and post-market risk management would be adopted for medical devices. This includes the implementation of a registration system and a…",
  "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."
}