{
  "id": 18704325,
  "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-18704325",
  "topic": "world",
  "section": "World",
  "published": "2026-11-07T11:07:53.000Z",
  "source": {
    "name": "RTHK News",
    "slug": "rthk-news",
    "url": "https://news.rthk.hk/rthk/en/component/k2/1876945-20261107.htm"
  },
  "original_language": "en",
  "account": "The Health Bureau aims to introduce a medical devices bill in the coming year to replace the current voluntary administrative regulatory system. In a paper submitted to the Legislative Council, the bureau outlined a dual-track regulatory model for medical devices, encompassing pre-market and post-market risk management. This model would involve a registration system and licensing system for traders, ensuring that medical devices supplied in Hong Kong meet safety and quality standards. The registration system would categorize different medical devices based on risk levels, with certain general devices and in-vitro diagnostic devices, such as hypodermic needles, vision-correction contact lenses, and urine test strips, required to register with the Department of Health before being launched in the Hong Kong market. Local manufacturers, importers, and wholesalers must also obtain the necessary licenses to supply these products in Hong Kong. The new system will mandate traders to report incidents related to medical devices, such as those posing public health threats or causing death or significant health deterioration, and to implement remedial measures in line with departmental requirements. The authorities emphasized that the objective is to strengthen regulatory oversight and mitigate the impact of such incidents. The proposed legislative changes will be deliberated at a health services panel meeting on 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."
}