Hong Kong’s Clinics to Prepare for Licensing Regime

On 23 May 2025, the Hong Kong Government gazetted the long-awaited commencement notices to implement the regulatory regime for clinics and small practice clinics (“SPCs”) under the Private Healthcare Facilities Ordinance (Cap. 633) (“PHFO”) from 13 October 2025 onwards. 

Enacted in 2018, the PHFO regulates private healthcare facilities where registered medical practitioners and/or registered dentists practise. 

The PHFO regulates four types of private healthcare facilities: hospitals, day procedure centres, clinics, and health services establishments. Currently, only hospitals and day procedure centres are subject to licensing requirements while the provisions concerning the licensing of clinics and health services establishments have yet to come into force.

1. Key Summary

• Application for Clinic Licence and Request for Letter of Exemption for SPCs under the Private Healthcare Facilities Ordinance (Cap. 633) will commence on 13 October 2025. The processing time is expected to take around 12 months.
• A clinic falls under the meaning of an SPC if it is operated exclusively by registered medical practitioners and/or registered dentists and meets certain specific conditions. For SPCs, a Letter of Exemption presents a more convenient and preferred route as it is free of charge and does not require to be renewed. 
• Clinics in operation since 30 November 2018 or earlier are eligible for transitional arrangement under which a Clinic Provisional Licence will allow the clinic to continue operation before a full licence is issued, or when the application for full licence is withdrawn or rejected.
• A Clinic Licence is valid for five years. Compliance with the Code of Practice for Clinics will be a condition for issuance and renewal of a Clinic Licence. 

2. Definition of Clinics and SPCs

2.1 Clinics ^[1]

Under the PHFO, a clinic is any premises:

• that do not form part of the premises of a hospital, a day procedure centre or an outreach facility; and
• that are used, or intended to be used, for:
  • the provision of medical services by registered medical practitioners and/or registered dentists to patients, without lodging; or
  • carrying out minor medical procedures (not being scheduled medical procedures or hospital-only medical procedures) on patients, without lodging.

2.2 SPCs^[2]

A clinic falls under the meaning of an SPC if it is operated exclusively by registered medical practitioners and/or registered dentists and satisfy the following prescribed conditions under the PHFO: 

3. Licensing Requirements and Exemptions

From 13 October 2025 onwards, all clinics (unless exempted) are required to apply for a Clinic Licence from the Office for Regulation of Private Healthcare Facilities of the Department of Health. Transitional arrangement is available for clinics that were already in operation on or before 30 November 2018, in view that they are more likely to require substantial alterations to meet the licensing requirements. 

As SPCs are exclusively operated by registered medical practitioners and/or registered dentists whose professional practice is already governed by existing legislations and applicable codes of practice, they may be exempted from licensing upon the issuance of a Letter of Exemption from the Director of Health. Requesting for a Letter of Exemption for an SPC is free of charge. 

The processing time for the Clinic Licence application or a Letter of Exemption request is initially estimated to take around 12 months due to the high volume of expected applicants.

3.1 Clinics in operation since 30 November 2018 or earlier:

• Eligible for transitional arrangement - may apply for a Clinic Provisional Licence from 13 October 2025 to 13 April 2026
• The Clinic Provisional Licence will allow the clinic to continue operation before a full licence is issued, or when the application for full licence is withdrawn or rejected

3.2 Clinics that commenced operation or relocated after 30 November 2018:

• Not eligible for transitional arrangement - must apply for a full licence unless otherwise exempted as an SPC

3.3 SPCs:

• May elect between applying for a Clinic Licence or requesting a Letter of Exemption from licensing^[3]
• A request for Letter of Exemption may be rejected if the Director of Health considers it inappropriate for the applicant to operate the clinic without a licence^[4]
• To be eligible for an exemption, an SPC must conform to the requirements on the premises under the PHFO including that it must be a distinct and exclusive premises. If there are services not reasonably incidental to the purpose of the medical or dental practice (e.g. beauty services), the SPC must be separated from those premises and that the SPC must have a direct and separate entrance 
• Each registered medical practitioner or registered dentist can have up to three SPCs exempted at the same time – a Clinic Licence is required for the fourth and subsequent clinics

As compared with a Clinic Licence, a Letter of Exemption is clearly the more convenient and preferred route for clinics falling under the meaning of SPCs as it is free of charge and has no defined term of validity. For SPCs, there appears to be no specific advantages to holding a Clinic Licence over a Letter of Exemption. 

4. Term and Compliance Obligations

4.1 Licensed Clinics:

A Clinic Licence is generally valid for five years. 

The licensee of a clinic is wholly responsible for ensuring the clinic complies with:

• the PHFO; 
• any conditions of the Clinic Licence;
• the Code of Practice for Clinics (“CoP”), also to come into effect on 13 October 2025; and
• any direction given by the Department of Health by notice in writing pursuant to the PHFO.

Pursuant to the PHFO, the CoP is issued by the Director of Health to provide standards for all clinics licensed under the PHFO. The CoP sets out the licensing standards in respect of the physical conditions, service delivery and care process, infection control, staffing, governance, risk management and contingency, and other matters related to the operation of a clinic. Compliance with the CoP is a condition for issuance and renewal of a Clinic Licence. 

4.2 SPCs with Exemption:

A Letter of Exemption remains valid unless and until the clinic is relocated, ceases operation, no longer falls under the meaning of an SPC, or the exemption is revoked by the Director of Health.

Operators of exempted SPCs must ensure that the clinics continue to meet the definition of SPCs under the PHFO and comply with all relevant conditions and requirements applicable to an SPC and its operation under the PHFO.

The regulatory regime for clinics under the PHFO has been long-awaited, since the implementation of the regimes for hospitals and day procedure centres in 2019 and 2020 respectively. It represents another milestone towards ensuring all premises providing medical services in Hong Kong meet the prescribed facility and safety standards. To prepare for its implementation, current clinic operators should familiarize themselves with the licensing requirements as well as the eligibility criteria for transitional arrangement and exemption from licensing. Clinic operators should also review the CoP to identify any potential areas requiring improvement, compliance updates, or enhanced protocols. 

[1] See section 6 of the PHFO

[2] See section 41 of the PHFO

[3] See item E3 of ORPHF - Regulation of Private Healthcare Facilities - FAQ

[4] See “Guidance Notes for Considering Inappropriateness” (PHF(E)_52A_Guidance_Notes_for_Considering_Inappropriateness).