DH advises public that injection treatments ought to just be administered by authorized physicians or signed up dental professionals
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In action to media queries concerning the Department of Health’s (DH) strategy to modify the Codes of Practice (CoPs) for certified personal health care centers (PHFs) to upgrade regulative requirements on making use of injectable and infusible items in PHFs, the DH today (September 29) reacted as follows:
In 2013, the Government accepted the suggestions of the Working Group on Differentiation in between Medical Procedures and Beauty Services under the Steering Committee on Review of Regulation of Private Healthcare Facilities that treatments including injections need to be considered as medical treatments and just be carried out by authorized doctors or signed up dental practitioners. Products planned for human parenteral injection are high-risk items. Unless they fall within other regulative classifications (e.g. medical gadgets or exclusive Chinese medications), they are typically categorized as pharmaceutical items under the Pharmacy and Poisons Ordinance (Cap. 138) and should be signed up with the Pharmacy and Poisons Board of Hong Kong before they can be offered or dispersed in Hong Kong. The “Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System (GN-00) ” released by the DH likewise clearly specifies injectable dermal fillers are categorized as medical gadgets.
All signed up pharmaceutical items bring a Hong Kong registration number in the format of “HK-XXXXX” on their plans. Members of the general public can utilize the “Search Drug Database” function on the site of the Pharmacy and Poisons Board of Hong Kong to inspect details on private signed up pharmaceutical items by going into the item name or active ingredient; all noted medical gadgets bring a listing number in the format of “HKMD XXXXXX”Members of the general public might describe the “List of Medical Devices” at the Medical Device Division’s site for comprehensive details.
The DH manages properties where authorized physicians and signed up dental practitioners practise under the Private Healthcare Facilities Ordinance (Cap. 633) (the Ordinance). The Government established the Advisory Committee for Regulatory Standards for Private Healthcare Facilities (Advisory Committee) under the Ordinance. It consists of members from the Hong Kong Academy of Medicine, the Hospital Authority, the academic community, and agents from personal healthcare facilities, signed up physicians’ along with dental practitioners’ associations. The regards to recommendation of the Advisory Committee are to create, evaluate and upgrade the requirements of policy for PHFs and make suggestions on the CoPs released by the Director of Health from time to time.
Considering that injectable and infusible items meant for human are high-risk items, the Advisory Committee has actually backed upgraded regulative requirements and needed that all injectable and infusible items utilized in certified PHFs should fall within among the following classifications:
i) Pharmaceutical items signed up or excused from registration under the Pharmacy and Poisons Regulations (Cap. 138A);
ii) Human organ or human tissue items in compliance with the Human Organ Transplant Ordinance (Cap. 465); or
iii) Medical gadgets noted under the Medical Device Administrative Control System (MDACS).
Due to the Advisory Committee’s choice, the DH will likewise modify the CoPs for certified PHFs appropriately. The DH plans to release the modified CoPs in the Gazette in the 4th quarter of 2026. The modified CoPs, other than for the areas on medical gadgets, will work one month after publication in the Gazette. To enable certified PHFs enough time to recognize certified alternative items, the requirement for utilizing injectable and infusible medical gadgets noted under MDACS will work on March 1, 2027.
Relating to the aforesaid requirement on injectable and infusible items, the DH released a letter on September 9, 2026, to alert licensees of PHFs, licence candidates and the medical gadget market. This letter, in addition to often asked concerns, have actually likewise been submitted to the DH’s site for recommendation.
The Ordinance states that operators of PHFs need to get a licence or a letter of exemption before they can run the appropriate PHFs. The regulative programs for personal medical facilities and day treatment centres have actually been totally executed, while the Government has actually begun accepting applications for center licences and ask for letters of exemption for little practice centers because October 2025. Any facilities (consisting of facilities declaring to offer charm services) that supply medical services/carry out medical treatments need to get a pertinent licence or letter of exemption under the Ordinance according to the nature of the medical services/procedures. The Government anticipates that, as early as completion of December 2027, any facilities (consisting of properties declaring to offer charm services) that supply medical services or perform medical treatments will be needed to hold an appropriate licence or letter of exemption under the Ordinance according to the nature of the services or treatments. Since the other day (September 28), the DH has actually provided an overall of over 3 400 center licences or letters of exemption for little practice centers.
Compliance with the CoP is a condition for the issuance and renewal of licences. The DH checks certified PHFs from time to time and will take regulative action if any certified PHF is discovered to be in infraction of the CoPs.
From time to time, the DH gets alerts of cases in which members of the general public have actually established problems following injection treatments, such as a possible case of botulism after a botulinum contaminant injection revealed on September 21 this year.
The DH has actually regularly advised the general public through numerous channels that injection treatments are medical treatments which ought to just be carried out by in your area signed up doctors or signed up dental experts. Members of the general public need to initially determine the complete name of the medical practitioner/dentist and inspect the List of Registered Medical Practitioners kept by the Medical Council of Hong Kong or the List of Registered Dentists kept by the Dental Council of Hong Kong. The expert certifications and pertinent qualifications of the medical practitioner/dentist must likewise be validated. Before getting an injection, members of the general public ought to initially comprehend the information of the treatment, possible dangers and possible issues to make a notified choice. They ought to decline injections from unidentified sources, as their quality and effectiveness are not guaranteed.
Anyone who is not a signed up physician or signed up dental practitioner will not carry out medical treatments; otherwise the individual might be charged for breaching the Medical Registration Ordinance (Cap. 161) and the Dentists Registration Ordinance (Cap. 156).
The prohibited sale or ownership of unregistered pharmaceutical items is a criminal offense. The optimum charge for each offense upon conviction is a fine of $100,000 and 2 years’ jail time. If an individual is thought of unlawfully supplying unregistered pharmaceutical items, the DH will perform examinations and take enforcement actions. If doctor are included, the DH will refer the case to appropriate expert regulative bodies for follow-up actions.