The licensing requirement is part of the Private Healthcare Facilities Ordinance, passed in 2018 but not enforced across the board because of a shortage of medical staff.

The law was applied to private hospitals in 2019 and to day procedure centres in 2020 and 2020, but not to clinics or health services establishments.

Clinics were defined as premises that are not part of a hospital or a day procedure centre and provide medical services or minor procedures that do not require patients to stay overnight.

Health authorities are also planning legislation to cover medical devices, including equipment used for cosmetic procedures, by as early as 2025, a government source said.

Calls for tighter rules came in 2012 after a 46-year-old woman died after 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 sparked a fresh look at regulation of the sector by the government.

At least 20 women are believed to have suffered bacterial infections last year after they were given 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.

But the insider said authorities aimed to enforce the law across the board this year.

A spokesman for the department said almost 40 per cent of positions for medical officers at its Office for Regulation of Private Healthcare Facilities were vacant at the start of December last year.

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.

Dr Cheng Chi-man, president of the Hong Kong Medical Association, which represents more than 15,000 doctors, said he did not think the enforcement of the licensing rule would be a problem for private doctors running their own clinics.

He added 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.

A legislative proposal to regulate the registration, use and marketing of medical devices, including those often 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 put forward a bill.

There are at present no specific laws designed to cover the import and sale of medical devices in Hong Kong.

The department introduced the Medical Device Administrative Control System, in 2004, under which manufacturers and importers can voluntarily list their medical devices with authorities.

“We hope to strengthen this system and then, for the next step, we will see whether legislation is needed,” the source said.

The source added next year would be the earliest time for the introduction of a bill.

There have been 4,697 medical devices 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 designed to give preference to 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.

Vam Cheng, chief executive officer of Good Union Corporation, a medical aesthetic devices supplier, said most manufacturers were not prepared 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 clearly outline how to define a device for medical or cosmetic purposes and whether it should be declared by manufacturers or decided by department guidelines.

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 he added it was similar to a medical procedure because it could create wounds and involved the use of sterile solution.

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 should require all importers of medical and cosmetic devices to enrol with the government and only those ruled to be medical devices should be registered.