The PHFO mainly regulates premises where registered medical practitioners and/or registered dentists practise. Under the Ordinance, four types of private healthcare facilities (PHFs) are subject to regulation, namely hospitals, day procedure centres (DPCs), clinics, and health services establishments. Operators of the above four types of PHFs need to obtain relevant licences or letters of exemption in order to continue their operation. Please refer to Part 1 of the PHFO for definitions of the four types of PHFs.

Hospital licences under the PHFO are required for operating private hospitals. For premises where registered medical practitioners or registered dentists practise and provide medical services without lodging, the premises will either need a DPC licence if ‘scheduled medical procedures\' defined under the PHFO are provided, or a clinic licence if such procedures are not provided. Please refer to section 2 and Schedule 3 to the PHFO for the definition of 'scheduled medical procedures'.

Under the PHFO, a clinic fulfilling the criteria of a small practice clinic (SPC) may apply for exemption. For details, please refer to Question A2.

Health services establishments encompass new modes of operation or delivery of healthcare services that entails a significant level of risk. Facilities for conducting clinical trials as described in Schedule 9 to the PHFO are to be regulated as health services establishments.

Under the PHFO, the operator of a small practice clinic (SPC) may request the Director of Health for a letter of exemption to operate the SPC without a licence. An SPC is a clinic operated only by registered medical practitioner(s), i.e. those who are on the full registration list of the general register of registered medical practitioners, and/or by registered dentist(s). The operation may be in the form of a sole proprietorship, a partnership or a company. Moreover, the following three necessary conditions must also be met.

(1) Number of doctors or dentists: –

• If the SPC is operated under a sole proprietorship, the sole proprietor must be a registered medical practitioner or a registered dentist;
• If the SPC is operated under a partnership or a company, there can only be a maximum of 5 partners or company directors, and all partners or company directors must be registered medical practitioners or registered dentists.

(2) The right to use the premises: –

• The sole proprietor of the sole proprietorship, or at least one partner of the partnership, or at least one director of the company shall have exclusive rights to use the premises forming the SPC; in other words, non-operators, non-partners or non-directors are not allowed to practise in the clinic; and
• Whether the clinic is operated as a sole proprietorship, a partnership or a company, the SPC cannot employ other doctors or dentists (except for locum arrangements).

(3) Locum arrangements: –

• For every registered medical practitioner or registered dentist operating the SPC, the total number of locum days for which another registered medical practitioner or registered dentist takes up the duties of the individual, must not exceed 60 days in a year, and the aggregate number of locum days for all the partners or directors operating the clinic must not exceed 180 days in a year.

Under the new regulatory regime, each registered medical practitioner or registered dentist may operate up to three SPCs with valid exemption at the same time.  Please refer to Part 4 of the PHFO for details.

The PHFO was gazetted on 30 November 2018.

The Government has been implementing the PHFO in phases based on the risk level of various types of private healthcare facilities. Applications for hospital licences and day procedure centre licences have been accepted since 2 July 2019 and 2 January 2020 respectively.  Applications for exemption of scheduled nursing homes had commenced on 2 January 2020 and already ended on 30 April 2020.  For clinics, the arrangements for applications of licences and requests for letters of exemption will be announced later.

The PHFO provides for the transitional arrangements for day procedure centres (DPCs) and clinics.

Under the transitional arrangements, operators of DPCs which were in operation on 30 November 2018 have already been issued with provisional licences. Applications for DPC provisional licences had already ceased on 30 April 2020. The provisional licences allow the DPCs to continue to operate during the transitional period under the new regulatory regime before being qualified for full licences. Please refer to Division 4 under Part 9 of the PHFO for details.

The Secretary for Health will appoint by notice published in the Gazette the date on which the transitional arrangements expire. A provisional licence issued to a licensee will expire on the appointed date, or when the licensee's application for the full licence is approved, withdrawn or rejected. In order to provide sufficient preparation time for the trade, the expiry date of the transitional arrangements will be at least one year after the date on which the notice is published.

Operators of DPCs which came into operation or were moved to another premises after 30 November 2018 need to comply with the requirements under the PHFO and apply for full licences.

The first batch of DPC licences (including both full and provisional licences) already came into effect on 1 January 2021.

Penalty provision pertaining to the operation of a DPC without a licence has commenced on 30 June 2022. Any person operating a DPC without a licence commits an offence and be liable on conviction to a fine of HK$100,000 and to imprisonment for 3 years.

The specified period for applications for provisional and full licences for clinics will be announced later.

All private healthcare facilities (PHFs) must hold a licence or a letter of exemption in order to legally operate. The provisional licences of day procedure centres allows those which were already in operation on 30 November 2018 to continue to operate during the transitional period under the new regulatory regime before they are qualified for a full licence. A PHF will be issued a full licence only when the PHF conforms to all licensing requirements and standards. When the transitional period comes to an end, these PHFs must be covered by a full licence.

The PHFO regulates premises of private healthcare facilities where registered medical practitioners and / or registered dentists practise. Irrespective of the frequency or duration of such practice, the operator is required to apply for a licence or request for a letter of exemption. In addition, the operator shall ensure the premises complies with other prevailing legislations relevant to the operation, such as the Medical Registration Ordinance, the Radiation Ordinance, etc.

Premises where registered medical practitioners and dentists practise are subject to regulation and licensing under the PHFO. If the services provided by Chinese medicine practitioners and allied health professionals are provided in the same premises where registered medical practitioners and registered dentists practise, such services will also be covered by the licences issued under the PHFO. The PHFO, however, does not cover premises where only allied health professionals practise. These allied health professionals will continue to be regulated under the applicable legislations and codes of practice governing the respective allied health professional practices.

Under the PHFO, any PHF where registered medical practitioners or registered dentists practise must be covered by a licence or a letter of exemption.

Under the PHFO, any PHF that is covered by a licence or an exemption shall:

• be a distinct and exclusive unit that is able to perform its functions independently, and is physically separated from any premises that serve a purpose not reasonably incidental to the type of facility for which the licence is issued or specified in the letter of exemption; and
• has a direct and separate entrance.

Except during the transitional phase in clinics (not yet in force) where a provisional licence is issued, all operators must ensure that the facility they operate has a direct and separate entrance not shared with any other premises.

For further details, please refer to Question B9.

The PHFO mainly regulates premises where registered medical practitioners and registered dentists practise. Any premises (including premises claiming to be providing 'beauty services') that provide medical services (e.g. carrying out medical procedures) require day procedure centre or clinic licences depending on the nature of medical services or procedures they provide. These premises are subject to licensing conditions imposed by the Department of Health and the relevant codes of practice. Applicants should pay attention to the requirements on distinct premises, direct and separate entrance, and relevant transitional arrangements as set out in the PHFO. Please also refer to Question B12 for more information on differentiating medical procedures from beauty services.  

The Department of Health conducts inspection to licensed private healthcare facilities to ensure compliance with the PHFO and the relevant codes of practice.

The licensing periods for different types of PHF licences are as follows:

• Hospital licence: 2 years
• Day procedure centre licence: 3 years
• Clinic licence: 5 years
• Licence of scheduled clinics listed in Schedule 6 of the PHFO: 1 year

The Department of Health has been announcing the details of the new licensing scheme in phases according to the implementation schedule and organising briefings for respective stakeholders. Please check out the latest announcements at our website.

Under the PHFO, the licensee of a hospital must be a legal person, i.e. a company, or other body corporate, operated by a board of directors, which must include a person who is not a registered medical practitioner, a registered dentist, nor an employee of the hospital. Apart from the 'scheduled clinics' listed in Schedule 6 of the PHFO, the licensee of any other private healthcare facility may be a legal or natural person, i.e. an individual, a partnership, a company, a body corporate other than a company, or a society.

The CME of a DPC shall be a registered medical practitioner or a registered dentist who has been registered in Hong Kong for not less than 6 years, and the CME of a clinic shall be a registered medical practitioner or a registered dentist who has been registered in Hong Kong for at least 4 years. If a DPC or clinic provides medical services, the CME must be a registered medical practitioner; if it only provides dental services, the CME must be a registered dentist; if it provides both medical and dental services, the CME must be a registered medical practitioner, and the licensee must also appoint a registered dentist to assist the CME in carrying out the day to day administration of the dental practice.

If a licensee who operates a group of 4 or more clinics has established for this group of clinics a Medical Advisory Committee (refer to Question B6) and appointed for each clinic in the group, according to the type of practice, a registered medical practitioner or a registered dentist who is serving at the clinic, to assist the CME in carrying out the day to day administration of the clinic, the licensee may appoint a single CME for this group of clinics. This appointed CME for the group of clinics will have to be a medical practitioner or dentist who has been registered in Hong Kong for not less than 8 years, and is not serving at the same time as the CME of another PHF.

Under the PHFO, the licensee of a PHF is wholly responsible for the operation of the facility. The licensee's responsibilities include ensuring the facility's compliance with the PHFO, licence conditions, codes of practice, etc.; appointing a CME for the PHF, setting up and enforcing rules, policies and procedures relating to the quality of care for, and the safety of, patients in the PHF; making available to the public information about the prices of chargeable items and services provided in the PHF; and putting in place complaints handling procedures.

The appointed CME is to take charge of the day to day administration of the facility. The CME's responsibilities also include adoption and implementation of rules, policies and procedures concerning healthcare services provided in the facility.

The licensee of a hospital must be a legal person, while the licensee of other PHFs can be a legal person or a natural person. As such, the licensee of PHFs other than hospitals may be appointed as the CME for the same PHF.

The above requirements for licensees and CMEs do not apply to small practice clinics with exemption in force.

Under the PHFO, the CME of a PHF is responsible for the day to day administration of the facility, and the adoption and implementation of rules, policies and procedures concerning the healthcare services provided in the facility. A registered medical practitioner or a registered dentist may only serve at the same time as a CME of one of the following –

• one private hospital (registered medical practitioner only);
• two day procedure centres;
• three clinics; or
• one day procedure centre and one clinic; or
• agroup of four or more clinics operated by the same licensee with:
  • a Medical Advisory Committee established; and
  • a registered medical practitioner or a registered dentist appointed for each of the clinics to assist the CME in carrying out the day to day administrationof the clinic.

For requirements on qualification of a CME in different types of PHFs, please refer to Part 5 of the PHFO.

A registered medical practitioner or a registered dentist who operates, or intends to operate, a small practice clinic may request the Director of Health for a letter of exemption for the clinic, regardless of whether he or she is serving as a CME of other PHF(s).

The operator of a PHF refers to the operator of any licensed PHF and the operator of any small practice clinic with exemption. Apart from the requirement that the operators of exempted small practice clinics must be registered medical practitioners or registered dentists, the PHFO does not require the operators of other PHFs to be doctors or dentists.

The licensee of a hospital is required, in addition to appointing a chief medical executive (CME), to establish and maintain an MAC. For a licensee who operates a group of 4 or more clinics at the same time, if an MAC is established and maintained for this group of clinics, and, for each of the clinics, a registered medical practitioner or registered dentist who is serving the specific clinic is appointed to assist the CME in carrying out the day to day administration of that clinic, the licensee may only appoint a single CME for this group of clinics.

If the private healthcare facility (PHF) is a medical practice or a combined medical and dental practice, the chairperson of the MAC must be a registered medical practitioner. If the PHF is a dental practice, the chairperson of the MAC must be a registered dentist. The number of members of the MAC is to be decided by the licensee, but at least half of the members must be registered medical practitioners or registered dentists, including at least 1 registered medical practitioner who is not employed by, or practising in, the concerned PHF.

If there is a change of the CME, the licensee must, before the expiry of 14 days after the change has occurred, notify the Director of Health in writing of the change.

Under the PHFO, the premises of licensed PHFs and exempted clinics must –

1. be distinct and exclusive premises, physically separated from any premises that serves a purpose not reasonably incidental to the facility, and
2. have a direct and separate entrance.

The transitional arrangement for licensed clinics on the above requirements is provided under the PHFO. During the validity period of a provisional licence, only clinics are not required to comply with the requirements on separate entrance, subject to certain conditions. This transitional arrangement is not applicable to day procedure centres and small practice clinics. Please refer to section 138 of the PHFO for details.

Under the PHFO, premises in relation to a PHF are interpreted as places if they are:

• physically connected by internal access among themselves; or
• physically attached or in close proximity to, or adjoining one another; and
• forming a distinct whole for the facility to function as a single entity.

If a PHF has several units in the same building, and these units have internal access among themselves, or adjoining to each other, such that they operate as a single entity, these units will be considered as part of the premises of the PHF.

Followings are some scenarios for a day procedure centre (DPC) or clinic premises to be covered by one licence:

• a DPC / clinic occupying 2 or more units connected with internal access
• a DPC / clinic occupying 2 or more adjoining units
• a DPC / clinic occupying 2 or more units within the same building

In a PHF, services such as those provided by dietitians and physiotherapists may justify as services reasonably incidental to the services of a clinic. Services such as beauty services (e.g. haircut, manicure) are expected to be not reasonably incidental to the intended practice. The operator of any PHF must ensure that the premises of the facility are physically separated from any premises that serve a purpose not reasonably incidental to the type of facility / practice as specified on any licence / letter of exemption. The operator has the responsibility to justify the reasonableness of any incidental service to be provided in the facility. In general, conducting sales promotion of medical insurance, providing catering services and selling daily necessities are not considered as being reasonably incidental to the medical or dental practices in a day procedure centre, clinic or small practice clinic.

In 2013, the Steering Committee on Review of Regulation of Private Healthcare Facilities published the "Report of the Working Group on Differentiation between Medical Procedures and Beauty Services". The report has made recommendations that the following four categories of procedures should be performed by registered medical practitioners or registered dentists:

• cosmetic procedures that involve injections ;
• procedures that involve the mechanical / chemical exfoliation of the skin below the epidermis ;
• hyperbaric oxygen therapy ; and
• dental bleaching.

Please refer to the "Report of the Working Group on Differentiation between Medical Procedures and Beauty Services" for details.

Operators of DPCs should observe the relevant requirements of the PHFO, the ‘Code of Practice for Day Procedure Centres\', and the 'Guidance notes for application for Day Procedure Centre licence'. Operators should also ensure to set up distinct and separate premises, as well as having separate entrance for the DPC, and appointing a chief medical executive with relevant qualifications.

Applications for day procedure cetnres provisional licences had already ceased on 30 April 2020. The application procedures for clinic provisional or full licences will be announced in due course.

The various CoPs and standards for private healthcare facilities are standards and specifications issued by the Director of Health under the PHFO.

The Code of Practice for Day Procedure Centre is available here.

For clinics, the Standards for Clinics was issued in December 2023. This standard will form the Code of Practice for Clinics when the relevant sections of the PHFO come into operation.  For further details, please click here.  

Operators of private healthcare facilities are advised to make reference to the relevant codes of practice and standards to ensure compliance.

The PHFO is a premise-based legislation. Hence, if both scheduled medical procedures and minor medical procedures are performed in the premises, the operator of that PHF would only need to apply for a DPC licence.

The PHFO is a premise-based legislation. Hence, if both scheduled medical procedures and minor medical procedures are performed in the premises, the operator of that PHF would only need to apply for a DPC licence.

Although the PHFO allows an SPC to be exempted from the requirement of a licence, the operator must still apply to the Director of Health for a letter of exemption. The details for application will be announced in due course.

There is a limit on the number of SPCs each operator may apply for exemption. Whether operating an SPC under sole proprietorship, a partnership or a company, each registered medical practitioner or registered dentist can have up to 3 SPCs exempted at the same time. They will have to apply for a licence for the 4th or subsequent clinics.

There is no expiry date for a letter of exemption issued to an SPC. That means it remains valid unless it is revoked by the Director of Health, or the SPC no longer conforms to the requirements of an SPC.

The letter of exemption of an SPC is issued to a specific operator of the SPC. Therefore, if there is an intended change in the operator(s), or in the address of the premises, or if the operator intends to cease operating the clinic, or to stop operating it as an SPC, he / she must give the Director of Health not less than 14 days\' advance notice in writing. The operator may have to re-apply for an exemption or apply for a licence because of the changes.

As far as the operation of an SPC is concerned, locum arrangement refers to the situation where another registered medical practitioner or registered dentist takes up the duties of a registered medical practitioner or registered dentist who is entitled to the relevant letter of exemption during the latter's absence. The two persons would not provide medical services at the SPC concerned at the same time.

However, part-time employment of any registered medical practitioner(s) or registered dentist(s) to provide medical services in the presence of the registered medical practitioner(s) or registered dentist(s) who is/are entitled to the relevant letter of exemption at the SPC concerned is not allowed.

Any locum period within a calendar day will be taken as one locum day.

According to section 41(3) of the PHFO, the operation requirement of an SPC requires that the clinic is operated by a company having not more than 5 directors, each of whom is a registered medical practitioner or a registered dentist; the directors are the only registered medical practitioners or registered dentists who serve the clinic; and either the company has, or one or more of the directors have, the exclusive right to use the premises forming the clinic. Hence the requirement applies to the directors but not shareholders.

When the Director of Health announces the date for accepting applications for clinic licences and letters of exemption of SPCs, the operator of any clinic that conforms to the requirements of an SPC can then request for a letter of exemption. The operator of any clinic that does not conform to the requirements of SPC must apply for a clinic licence. Thereafter, any person who intends to operate a clinic must have applied for and is issued with a clinic licence or a letter of exemption to begin operating a clinic to provide medical services. The operator of any clinic who is issued with a clinic licence may put up a request to the Director of Health to ask for a letter of exemption if the clinic subsequently conforms to the requirements of an SPC.