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Major New Regulations for Hong Kong Aesthetic Medicine! Mandatory Listing for Injectable Products!

Time：2026-09-14 10:54:47

On 9 September 2026, the Department of Health of Hong Kong issued an updated regulatory circular to all licensed private healthcare facilities (PHFs), including private hospitals, day procedure centres and clinics, as well as licence applicants. It sets unified compliance standards for all injectable and infusible products. Injectable dermal fillers for aesthetic use are brought under key regulatory control. The mandatory listing requirements for medical devices will take effect on 1 March 2027, exerting a direct impact on Hong Kong aesthetic clinics, product distributors and registered medical practitioners. Moving forward, injectable and infusible products used in licensed private healthcare facilities will be prohibited unless they fall into one of the following three categories.

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https://www.orphf.gov.hk/files/letter/Use_of_Injectable_and_Infusible_Products.pdf

一、Overview of Core New Rules

The new regulations have been vetted by the Advisory Committee on Standards for Private Healthcare Facilities Regulation. They cover three major product categories: Pharmaceutical Products, Human Organ/Tissue Products and Medical Devices, each governed by separate ordinances.

（一）Pharmaceutical Products (PPs) | Governed by Cap.138

Under the Pharmacy and Poisons Ordinance (Cap.138), pharmaceutical products must in principle be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold, distributed or used locally in Hong Kong.

Limited Exemption： A registered medical practitioner / registered dentist may prescribe unregistered pharmaceutical products for treatment of a specific individual patient. Import of such products must be covered by a valid import licence under the Import and Export Ordinance (Cap.60).

Obligations for Facilities：Retain complete procurement records. For unregistered pharmaceutical products imported under exemption, full documentation including import licences must be filed for inspection.

（二）Human Organ / Human Tissue Products | Governed by Cap.465

This applies to processed human organ and tissue products for transplantation purposes, such as skin grafts and bone graft materials, regulated under the Human Organ Transplant Ordinance (Cap.465).

Prerequisite for Use：Either obtain exemption from the Director of Health, or fully comply with all requirements under Cap.465.

Critical Red Line for Aesthetic Facilities (Effective Immediately): Procedures involving transplantation of cells, tissues or organs are designated medical procedures listed in Schedule 3 of the Private Healthcare Facilities Ordinance (Cap.633). Save for a few exceptions specified in Column 3 of Schedule 3, ordinary clinics are NOT permitted to perform injection or infusion operations involving human organ/tissue products. Such procedures may only be carried out in private hospitals and day procedure centres.

（三）Medical Devices (MDs) | MDACS Listing, Mandatory from 01/03/2027

The Medical Device Administrative Control System (MDACS), established in 2004, was previously a voluntary listing regime. The new rules clarify that starting from 1 March 2027, all injectable and infusible medical devices used by licensed private healthcare facilities must complete MDACS listing registration prior to use.

Aesthetic Products Explicitly Included in Mandatory Scope：Injectable dermal fillers (including hyaluronic acid and other aesthetic filler injections), injectable mucosal fillers.

Timeline for Revised Code of Practice：The Department of Health plans to publish the revised Code of Practice in the Hong Kong Gazette in Q4 2026. Except for medical device-related clauses, other provisions will take effect one month after gazettal. The mandatory MDACS requirement for medical devices is separately deferred to 1 March 2027. Licence issuance and renewal for facilities are conditional upon compliance with the Code of Practice; licensed facilities bear full compliance responsibility for all operational aspects.

二、Breakdown of Business Impacts on Stakeholders in the Aesthetic Industry

（一）For Practitioners at Clinics & Aesthetic Facilities

After 1 March 2027, all injectable filler products (for skin and mucosal filling), classified as medical devices, must have verifiable MDACS listing records before procurement and clinical use by facilities. Products without listing records are prohibited from clinical application.

If a product is classified as a pharmaceutical product, full pharmaceutical registration is required. Unregistered pharmaceutical products may only be used for specific patients with prescriptions from registered practitioners and valid import licences. Bulk procurement of unregistered pharmaceutical products for general customers is not allowed.

Human Tissue Injection Projects: Banned for most scenarios in general clinics. Non-compliant operations will breach Cap.633.

Maintain Complete Documentation: Retain product purchase invoices, import documents, registration / exemption / MDACS listing verification records. Regulators will focus on reviewing such files during licence renewal; non-compliance may directly affect licence renewal.

Reminder for Facilities：Do not wait until close to the effective date to start product replacement and document rectification. It is recommended to immediately sort out the inventory of existing injectable and infusible products on-site, verify compliance attributes one by one, classify products into pharmaceutical products, medical devices or human tissue products, phase out non-compliant stock in advance, and avoid risks such as shortage of compliant products or licence inspection non-conformities.

（二）For Product Agents & Traders

Engage with manufacturers promptly to initiate MDACS listing applications for the Hong Kong market and reserve sufficient review lead time.

Proactively share the MDACS listing status of each product with downstream partner clinics and medical institutions, to assist them in switching to compliant products by 1 March 2027.

Before each batch delivery, verify the product’s listing status in the official database to mitigate commercial and compliance risks.

三、Conclusion

This new regulation marks a major regulatory upgrade in Hong Kong for private healthcare and aesthetic injection sectors. MDACS was previously a voluntary registration system, but will become mandatory after 1 March 2027, directly governing all licensed aesthetic clinics, day centres and private hospitals across Hong Kong.For further enquiries, please contact Wiselink Group!

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