DH reminds public that injection procedures should only be administered by registered medical practitioners or registered dentists
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In 2013, the Government accepted the recommendations of the Working Group on Differentiation between Medical Procedures and Beauty Services under the Steering Committee on Review of Regulation of Private Healthcare Facilities that procedures involving injections should be regarded as medical procedures and only be performed by registered medical practitioners or registered dentists. Products intended for human parenteral injection are high-risk products. Unless they fall within other regulatory categories (e.g. medical devices or proprietary Chinese medicines), they are generally classified as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) and must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold or distributed in Hong Kong. The "Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System (GN-00) " published by the DH also explicitly stipulates injectable dermal fillers are classified as medical devices.
All registered pharmaceutical products carry a Hong Kong registration number in the format of "HK-XXXXX" on their packages. Members of the public can use the "Search Drug Database" function on the website of the Pharmacy and Poisons Board of Hong Kong to check information on individual registered pharmaceutical products by entering the product name or ingredient; all listed medical devices carry a listing number in the format of "HKMD XXXXXX". Members of the public may refer to the "List of Medical Devices" at the Medical Device Division's website for detailed information.
The DH regulates premises where registered medical practitioners and registered dentists practise under the Private Healthcare Facilities Ordinance (Cap. 633) (the Ordinance). The Government set up the Advisory Committee for Regulatory Standards for Private Healthcare Facilities (Advisory Committee) under the Ordinance. It comprises members from the Hong Kong Academy of Medicine, the Hospital Authority, the academia, and representatives from private hospitals, registered medical practitioners' as well as dentists' associations. The terms of reference of the Advisory Committee are to devise, review and update the standards of regulation for PHFs and make recommendations on the CoPs issued by the Director of Health from time to time.
Since injectable and infusible products intended for human are high-risk products, the Advisory Committee has endorsed updated regulatory requirements and required that all injectable and infusible products used in licensed PHFs must fall within one of the following categories:
i) Pharmaceutical products registered or exempted from registration under the Pharmacy and Poisons Regulations (Cap. 138A);
ii) Human organ or human tissue products in compliance with the Human Organ Transplant Ordinance (Cap. 465); or
iii) Medical devices listed under the Medical Device Administrative Control System (MDACS).
In light of the Advisory Committee's decision, the DH will also revise the CoPs for licensed PHFs accordingly. The DH intends to publish the revised CoPs in the Gazette in the fourth quarter of 2026. The revised CoPs, except for the sections on medical devices, will take effect one month after publication in the Gazette. To allow licensed PHFs sufficient time to identify compliant alternative products, the requirement for using injectable and infusible medical devices listed under MDACS will take effect on March 1, 2027.
Regarding the aforesaid requirement on injectable and infusible products, the DH issued a letter on September 9, 2026, to notify licensees of PHFs, licence applicants and the medical device industry. This letter, as well as frequently asked questions, have also been uploaded to the DH's website for reference.
The Ordinance stipulates that operators of PHFs must obtain a licence or a letter of exemption before they can operate the relevant PHFs. The regulatory regimes for private hospitals and day procedure centres have been fully implemented, while the Government has started accepting applications for clinic licences and requests for letters of exemption for small practice clinics since October 2025. Any premises (including premises claiming to provide beauty services) that provide medical services/carry out medical procedures must obtain a relevant licence or letter of exemption under the Ordinance according to the nature of the medical services/procedures. The Government expects that, as early as the end of December 2027, any premises (including premises claiming to provide beauty services) that provide medical services or carry out medical procedures will be required to hold a relevant licence or letter of exemption under the Ordinance according to the nature of the services or procedures. As of yesterday (September 28), the DH has issued a total of over 3 400 clinic licences or letters of exemption for small practice clinics.
Compliance with the CoP is a condition for the issuance and renewal of licences. The DH inspects licensed PHFs from time to time and will take regulatory action if any licensed PHF is found to be in violation of the CoPs.
From time to time, the DH receives notifications of cases in which members of the public have developed complications following injection procedures, such as a probable case of botulism after a botulinum toxin injection announced on September 21 this year.
The DH has consistently reminded the public through various channels that injection procedures are medical procedures which should only be performed by locally registered medical practitioners or registered dentists. Members of the public should first ascertain the full name of the medical practitioner/dentist and check the List of Registered Medical Practitioners maintained by the Medical Council of Hong Kong or the List of Registered Dentists maintained by the Dental Council of Hong Kong. The professional qualifications and relevant credentials of the medical practitioner/dentist should also be verified. Before receiving an injection, members of the public should first understand the details of the procedure, potential risks and possible complications to make an informed decision. They should refuse injections from unknown sources, as their quality and efficacy are not assured.
Any person who is not a registered medical practitioner or registered dentist shall not perform medical procedures; otherwise the person may be charged for violating the Medical Registration Ordinance (Cap. 161) and the Dentists Registration Ordinance (Cap. 156).
The illegal sale or possession of unregistered pharmaceutical products is a criminal offence. The maximum penalty for each offence upon conviction is a fine of $100,000 and two years' imprisonment. If a person is suspected of illegally providing unregistered pharmaceutical products, the DH will conduct investigations and take enforcement actions. If medical professionals are involved, the DH will refer the case to relevant professional regulatory bodies for follow-up actions.
Ends/Tuesday, September 29, 2026
Issued at HKT 21:51
Issued at HKT 21:51
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