Hong Kong clinics will have to obtain a licence as early as this year as authorities tighten the enforcement of rules following a series of botched beauty treatments, the Post has learned.
A registered doctor or dentist will have to be appointed the “chief medical executive” for each licensed clinic, and the business must draw up rules to ensure the quality of services and patients’ safety.
Clinics must also make public the prices of their services and set up procedures for handling complaints.
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These measures are outlined on the Department of Health website, which also states that “small practice clinics” run by a single doctor or dentist or a group practice with fewer than five partners or directors may apply for exemption from having a licence.
The licensing requirement falls under the Private Healthcare Facilities Ordinance passed in 2018 but not enforced across the board because of a lack of medical staff.
The law was applied to private hospitals and day procedure centres in 2019 and 2020, respectively, but not at clinics or health services establishments.
Clinics refer to premises that are not part of a hospital or a day procedure centre, and that provide medical services or minor procedures that do not require patients to stay overnight.
Health authorities were also planning legislation to cover medical devices, including equipment used for cosmetic procedures, by as early as 2025, a government source said.
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Calls for tighter rules first surfaced in 2012 after a 46-year-old woman died in 2012 following high-risk experimental cell therapy injections at a beauty centre.
Proposals to legislate the use of medical devices such as those involved in laser, radiofrequency or intense pulsed light procedures were floated in 2017 but faced strong opposition by the beauty sector.
The city has about 6,000 beauty parlours, but it is not clear how many provide medical beauty services.
The 2012 case was the most shocking, as it was the first time someone died from a beauty procedure, and it prompted the government to look into regulating the sector.
Since November last year, at least 20 women were believed to have been infected after receiving injections at four beauty premises. Several beauty centre workers were arrested.
The source said a severe shortage of manpower at the Department of Health prevented authorities from extending the existing rules to all clinics sooner, as it had to hire doctors to carry out inspections.
Authorities were now aiming to enforce the law this year, the insider added.
A spokesman for the department said close to two-fifths of positions for medical officers at its Office for Regulation of Private Healthcare Facilities were vacant as of December 1.
He said the vacancies resulted from the creation of about 15 new posts in 2020, while many doctors had left the service.
“Because of the Covid-19 pandemic, the department had difficulties [filling] the vacancies in time and [it is] striving to strengthen the medical support to the office,” he said.
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Dr Cheng Chi-man, president of the Hong Kong Medical Association, which represents more than 15,000 registered doctors in the city, did not think the enforcement of the licensing rule would pose a problem for private doctors running their own clinics.
He believed that eligible small clinics would apply for exemption.
The department said it was preparing to start the clinic licensing and exemption procedures, and was also developing regulatory standards and a code of practice for clinics.
Separately, the source said authorities were planning to reintroduce legislation stalled since 2018 to cover medical devices.
A legislative proposal to regulate the registration, use and marketing of medical devices, including those commonly used in cosmetic procedures, was submitted by the government in 2017.
It was revised the following year after strong opposition from the beauty sector, but the government did not follow up with a legislative bill.
Currently, there are no specific laws covering the import and sale of medical devices in Hong Kong.
In 2004, the department introduced the Medical Device Administrative Control System, under which manufacturers and importers may voluntarily list their medical devices with the authorities.
“We hope to strengthen this system and then, for the next step, we will see whether legislation is needed,” the source said, adding that 2025 was the earliest for any bill.
So far, 4,697 medical devices had been listed under the voluntary system, the department said. Each item may have one or more models.
In June last year, the department implemented a procurement strategy of giving preference for the purchasing of devices voluntarily listed with authorities.
Public healthcare facilities under the Hospital Authority were expected to adopt a similar procurement arrangement this year, the source said.
The Hong Kong Centre for Medical Products Regulation, to be established to help set up the city’s own drug registration and review system, would also regulate medical devices in future.
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Vam Cheng, chief executive officer of Good Union Corporation, a medical aesthetic devices supplier, said most manufacturers were not willing to go for registration under the voluntary mechanism.
Those who did would have their storage facilities, logistics and import documents inspected by the authorities.
“Without registration, no regulation is needed,” Cheng said.
He said authorities should state clearly how to define a device for medical or cosmetic purposes, and whether it should be declared by manufacturers or decided by department guidelines.
For example, mesotherapy, a procedure involving injections of vitamins, enzymes, hormones or plant extracts for skin rejuvenation or fat removal, was considered a cosmetic procedure overseas, Cheng said.
But it was similar to medical procedure, as it could create wounds and involved the use of sterile solution, he said.
If such products had to be registered as medical devices, he said, they would not have enough overseas documents to support local registration.
He warned that regulating all equipment as medical devices could result in many products not entering Hong Kong.
Cheng suggested that the government require all importers of medical and cosmetic devices to enrol with the government, and only those deemed to be medical devices should be registered.
More from South China Morning Post:
- Hong Kong day procedure centre stripped of licence over handling of suspicious jabs, failure to maintain patient records
- Botched Botox, fatal blunders: is it time to rein in Hong Kong’s medical beauty industry? Complaints mount over loose rules, ‘unprotected’ clients
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