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Industry Urged to Improve Substandard Quality and Service of Medical Devices Calling for Stronger Governance to Strengthen Consumers’ Right to Safety

  • 2024.01.15

When treating illnesses, it may be necessary to employ different medical devices for monitoring health conditions, such as blood glucose meters commonly used by diabetic patients, hearing aids for the hearing-impaired, and continuous positive airway pressure (CPAP) respirators for sleep apnea sufferers. However, if these medical devices are poor in quality or malfunction, not only would they affect patients’ daily lives, but they would also pose serious health risks. The Consumer Council has received many complaint cases related to medical devices in recent years, from traders selling expired products, inadequate scope of warranty service coverage, to serious delays in replacing recalled parts with health risks, the situation of which is concerning. The Council urges traders to ensure that their products meet both quality and specification standards. When issues arise, manufacturers and distributors should fulfil their responsibilities and follow up promptly, so as to reduce the impact on consumers.

Currently, there is no specific legislation for regulating the manufacture, importation, distribution, supply and use of medical devices in Hong Kong. Consumers may reference the listing of medical devices under the “Medical Device Administrative Control System” (MDACS) by the Department of Health (DH), which lists devices that comply with the requirements in terms of safety, quality, and performance. However, as MDACS is a voluntary system, the Council hopes the Government would tighten the regulatory regime to improve the safety and reliability of medical devices in the marketplace, in order to broaden protection for consumers.

Case 1: Trader Insisted No Quality Issues with Old and Expired Model of Blood Glucose Meter Sold

The complainant purchased blood glucose test strips from Pharmacy A, only to learn that they were not compatible with the blood glucose meter he owned, but with an older model. The staff at Pharmacy A rejected his request for an exchange, and instead suggested that he could purchase the older model of the meter to use with the test strips. The complainant eventually agreed after persuasion. However, he soon discovered from the packaging of the device that it had expired for over 3 years, while the accompanying lancet (the needle for collecting blood samples) had also expired for over 1.5 years. He returned to negotiate with Pharmacy A on the same day, but the staff rudely insisted that there were no quality issues with the product and refused to compromise. The complainant thus approached the Council for assistance.

After conciliation by the Council, Pharmacy A agreed to either refund the cost of the old model of blood glucose meter, or let the complainant exchange the test strips by settling the price difference. The complainant accepted the refund arrangement.

Case 2: Main Shell of Hearing Aid Lost After Coming Loose
Inadequate After-Sales Protection Terms Revealed

The complainant purchased a pair of hearing aids from Company B for around $28,000 with a one-year warranty. Each hearing aid consisted of an earmould and a main shell, the connection of which was adjusted and positioned by the staff at the time of purchase. After just a few months, the two connected parts of the left hearing aid unexpectedly came loose. Despite the complainant’s repeated attempts to reattach them for continued use, the main shell kept falling off and was eventually lost. The complainant’s family found that the connection wire of the left earphone was significantly shorter than the right one, and they considered this to be the cause of the loose connection. However, upon discovering that the warranty did not cover the replacement of the main shell and parts (such as earmoulds), the complainant’s family complained to Company B about the inadequate scope of warranty coverage, while maintaining that a free remake of the main shell should be provided during the warranty period. Company B on the other hand claimed that the complainant should have approached them for inspection and readjustment as soon as the problem occurred, and that the remake of the main shell would cost $10,000. Opining that there were pre-existing quality issues with the product, and that the warranty terms failed to adequately protect consumers, the family lodged a complaint with the Council.

Company B replied that the length of the connection wire in a hearing aid was customised to the ear shape of each customer, and agreed to arrange a new main shell and remake of the earmould for the complainant at an administrative charge of $1,860, but the family declined this arrangement. The Council recommended that the complainant could consider seeking independent legal advice before deciding on further legal actions against the trader.

Case 3: CPAP Respirator Parts Posed Safety Risks
Recall and Exchange of Parallel Imports Delayed for Nearly 2 Years

The complainant had been using a CPAP respirator for years. In November 2021, she was notified by Company C that the microparticles from the CPAP respirator’s degraded sound-dampening foam may pose carcinogenic risks, and that a recall would be arranged. As per the instructions by Company C, the complainant contacted the distributor to register for a recall. In 6 months’ time, she had called the distributor twice to enquire about the recall status but to no avail. Up until January 2023, she still had not received any news, and feeling helpless, she sought help from the Council.

The Council urged Company C multiple times that they should contact affected consumers proactively regarding the recall arrangements. Thereafter, the Council was informed that the complainant’s respirator was not supplied by Hong Kong’s sole agent, but was a parallel import, and thus would require time for special arrangements. It was not until September 2023, after almost 2 years, that the complainant finally had the defective parts replaced.

Medical devices are vital for chronic patients. Any abnormalities can lead to unimaginable consequences. Consumers are advised to take heed of the following before and after purchasing a medical device:

  • Consult a professional prior to purchasing a medical device, such as doctors or other medical practitioners (e.g. audiologists);
  • Reference the MDACS listing by the DH to ensure the safety, quality, and performance of medical devices meet relevant requirements. Details can be found at ;
  • When making a purchase online, consider buying from traders with an office or physical stores in Hong Kong to enjoy local warranty and after-sales services. Also, in case of disputes, seeking legal redress against local traders would be more convenient;
  • Some medical devices may offer a trial. Consumers may consider trying out a device at a lower cost to determine its suitability;
  • Warranties of medical devices generally do not cover damage resulting from man-made causes or accidents and consumable parts. Check if warranty registration is required, and retain receipts and warranty records properly for proof in case of disputes;
  • When having difficulties with a medical device, it is not advisable to attempt any unguided adjustment or calibration. Follow the user manual or guidance of healthcare professionals to ensure satisfactory results from the device and minimise any potential adverse effects.


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