Press Conference Case Sharing: Study on Global Consumer Medical Devices Regulation and Policy Recommendations
- Prologue Editorial
- Nov 21, 2025
- 4 min read
With the holidays around the corner, many citizens would choose to wear cosmetic contact lenses sourced from unregulated channels, which could easily cause serious eye damage and may even require surgery. The Policy Address proposes that the Government will establish the Hong Kong Centre for Medical Products Regulation in 2026 and put forward legislative proposals for the regulation of medical devices, with a view to positioning Hong Kong as an internationally recognized authority in medical products regulation. The Prologue team facilitated a research regarding consumer medical devices regulation and a press conference, unveiling the findings of an international study and local survey, along with a series of policy recommendations.
The Hong Kong Association of Private Practice Optometrists (the association) recently conducted a comparative study on global consumer medical device regulation, including contact lenses, and carried out a telephone survey of over 1,000 citizens. The association found that Hong Kong still has no dedicated legislation on medical devices, and that the public generally finds it difficult to distinguish parallel-imported products. Ophthalmologist Dr. Justin Tong Man-kit also attended the press conference to share patient cases and the risks of improper contact lens use.
A total of 13 media organizations attended the press conference, generating as many as 82 media coverage, including coverage by major outlets such as Wen Wei Po, Hong Kong Economic Times, Oriental Daily, Hong Kong Economic Journal, and the South China Morning Post. As the press conference was held close to Halloween, it successfully drew follow-up feature stories from multiple media organizations, including HOY TV, RTHK TV 31 program “Hong Kong United”, RTHK Radio programs “18heartfeltvibes” and “Backchat”, as well as Ming Pao.
Consumer medical devices refer to medical device products directly accessible to consumers for purchase. In addition to small and medium-sized home medical equipment, this also includes portable medical devices, including contact lenses. In its comparative study. the association found that Chinese Mainland, Singapore, Australia, the United States, the United Kingdom, and some Southeast Asian regions have all established robust medical device regulatory systems and laws covering the regulation of consumer medical devices. Many countries or regions have also set up specialized regulatory measures specifically for contact lenses.
Additionally, the association successfully interviewed 1,008 citizens via a telephone survey. Respondents generally considered parallel-imported products unsafe (81.7%), yet only a quarter (25.7%) believed they could differentiate parallel-imported products. Regarding whether Hong Kong should establish mandatory registration requirements for all consumer medical devices, 40.9% of respondents indicated they “agreed” or “strongly agreed,” while less than 30% disagreed. Respondents were divided on the issue of banning online platforms and physical stores from selling unregistered medical devices: 54.8% of those who occasionally purchased these products themselves supported the ban on unregistered products, compared to only 23.7% of frequent purchasers who supported the ban, with more than half of frequent purchasers opposing it.
Queenie Yip Siu-lai, the president of the Hong Kong Association of Private Practice Optometrists stated that while regulatory approaches to contact lenses vary across different places, all the other places have higher regulatory requirements for this higher-risk consumer medical device compared to Hong Kong. She added that parallel-imported products pose safety risks and can directly harm wearers' health, prompting the association to conduct a public survey on citizens' awareness and propose recommendations to help the Hong Kong government develop relevant regulations.
Ophthalmologist Dr. Justin Tong Man-kit said he received about 5 to 10 cases yearly of patients with improper use of contact lenses, consequences have ranging from corneal abrasions to bacterial infections that may result in vision loss. He emphasized that both corrective and cosmetic contact lenses should be fitted by a registered optometrist or ophthalmologist, as even a single instance of improper wear can potentially lead to irreversible eye damage.
The Health Bureau plans to submit legislative proposals on the regulation of medical devices to the Legislative Council in 2026. To further strengthen the local regulatory framework, the association has put forward six key policy recommendations: introducing mandatory registration for consumer medical devices, establishing registration requirements for importers, distributors, and wholesalers, restricting online sales, imposing prescription requirements for high-risk medical devices, monitoring physical stores and online platforms that sell medical devices and conducting joint inspections of imported medical devices in collaboration with the Customs and Excise Department.
📍Feature Interview Highlights:
📍Selected Media Coverage:
文匯報 – 「水貨」隱形眼鏡隱患多 專業機構呼籲消費者小心使用 [Link]
大公報 – 戴水貨隱形眼鏡 易致眼部感染損視力 [Link]
香港經濟日報 – 隱形眼鏡｜隱形眼鏡非正規渠道購買污染率高 執業眼科視光師協會倡強制註冊限網購 [Link]
東方日報 – 「水貨Con」隨時惹禍上身 視光師協會促規管 買隱形眼鏡需處方 [Link]
星島日報 – 「水貨」大眼仔高風險可致盲 萬聖節扮鬼勿亂戴 [Link]
am730 – 亂戴水貨con 或致視力受損 [Link]
信報 – 醫生警告「大眼仔」易損視力 [Link]
South China Morning Post – Hong Kong eye specialists warn of risks of wearing unregulated contact lenses [Link]
頭條日報 – 戴「水貨大眼仔」易損視力 醫生：逢節日後求助個案增 [Print]
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