Licence to heal – Licensing requirements for clinics and small practice clinics will commence

On 23 May 2025, the Hong Kong government gazetted the Private Healthcare Facilities Ordinance (Commencement) Notice 2025 (“Notice”) which, among other things, will bring into operation certain sections of the Private Healthcare Facilities Ordinance (Chapter 633 of the laws of Hong Kong) (“PHFO”) that will result in licensing requirements for clinics and small practice clinics (i.e. clinics having not more than five registered medical practitioners and/or registered dentists that meet specific conditions under the PHFO).

Background

The PHFO protects patient safety and rights through the introduction of a regulatory regime in which four (4) types of private healthcare facilities (“PHF”) are subject to regulation, namely hospitals, day procedure centres, clinics and health services establishments.

Currently, only hospitals and day procedure centres are subject to licensing requirements. The relevant sections of the PHFO that govern the licensing requirements for clinics and health services establishments have not yet come into operation.

New Requirements

The Notice will expand the licensing requirements under the PHF regulatory regime to cover clinics and small practice clinics by bringing into operation the licensing requirements under the PHFO for clinics from 13 October 2025 onwards.

Clinics will be required to comply at all times with the PHFO, the licence conditions and the codes of practice issued by the Director of Health from time to time.

The sections governing health services establishments will not yet come into operation.

Licence Application

Clinics already in operation on or before 30 November 2018 (the gazette date of the PHFO) may require material alterations to meet licensing requirements. Operators of such clinics may apply for a licence between 13 October 2025, and 13 April 2026 as a transitional arrangement. The Department of Health may issue a provisional licence which allows these clinics to continue their operation before a full licence is issued.

Operators of clinics which commenced operation after 30 November 2018 (including those which started businesses or moved to new premises) can directly apply for a full licence from 13 October 2025 onwards.

Operators of small practice clinics would need to obtain a letter of exemption from the Department of Health from obtaining a licence from 13 October 2025 onwards for their continued operation.

Code of Practice for Clinics

On 23 May 2025, the Hong Kong government also gazetted the Code of Practice for Clinics (“COP”) which contains requirements for licenced PHFs to, among other things:

(a) have a chief medical executive who is a medical practitioner (or for a facility with a dental practice only, a dentist) registered for not less than 4 years in Hong Kong at all times, and to hold the the chief medical executive accountable for the clinical management of the facility;

(b) require all staff involved in clinical care to be appropriately trained, including training in the safe and proper use of any medical equipment present in the facility;

(c) require clinical assistants to work under the supervision of a healthcare professional;

(d) require the physical design, size, layout and condition of the facility to be appropriate for the safe and effective delivery of services and the needs of its patients;

(e) require facilities to establish written policies and procedures for patient identification and to protect the rights of its patients, including without limitation patients having the right to:

(i) know the name and rank of the staff providing services;

(ii) be informed of the treatment planned for them and give informed consent of their treatment; and

(iii) access their own medical records;

(f) maintain accurate and up-to-date medical records that must include various details of the patient, such as name, gender, date of birth, contact telephone number, drug allergy history, relevant consultation notes, investigations and treatments;

(g) ensuring a written incident management and reporting system outlining the procedures to follow in the case of an incident or adverse event; and

(h) ensuring that all staff observe up-to-date infection control and preventive measures.

As licenced clinics will be required to comply with the COP and many of the requirements will take time to implement, it is advisable for clinic operators to consider commencing the compliance process earlier rather than later to avoid any delays or disruptions to their operations after the PHFO amendments become effective.

Edmond Leung and John Lee

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Disclaimer: This publication is general in nature and is not intended to constitute legal advice. You should seek professional advice before taking any action in relation to the matters dealt with in this publication. This article was last reviewed on 29 May 2025.