On 9 September 2026, the Office of Regulation of Private Healthcare Facilities (ORPHF) of the Department of Health issued a letter updating the regulatory requirements for the use of injectable and infusible products in licensed private healthcare facilities (PHFs) — including private hospitals, day medical centres and licensed clinics — under the Private Healthcare Facilities Ordinance (Cap. 633).
From 1 March 2027, all injectable and infusible medical devices used in licensed PHFs must be listed under the Medical Device Administrative Control System (MDACS).
Source: Department of Health, HKSAR — Update on Regulatory Requirements on the Use of Injectable and Infusible Products in Licensed Private Healthcare Facilities | www.orphf.gov.hk/files/letter/Use_of_Injectable_and_Infusible_Products.pdf
1. Three Product Categories Subject to Different Requirements
All injectable and infusible products used in licensed PHFs must fall within one of the following three categories.
| AS SET OUT IN THE DH LETTERAll injectable and infusible products used in licensed PHFs must fall within one of the following categories:1. Pharmaceutical products registered under Cap. 138A (or pharmaceutical products exempted from registration under Cap. 138A, for example, imported and used for treatment of a particular patient by a registered medical practitioner or a registered dentist covered by a valid import licence issued under Cap. 60);2. Human organ / human tissue products in compliance with Cap. 465; or3. Medical devices listed under MDACS. |
| Product Category | Compliance Requirement | Governing Provision |
| Pharmaceutical products | Registered under Cap. 138A, or eligible for an exemption from registration under Cap. 138A. | Cap. 138A |
| Human organ / human tissue products | In compliance with Cap. 465, or a written exemption has been obtained from the Department of Health. | Cap. 465 |
| Medical devices | Listed under the Medical Device Administrative Control System (MDACS). | MDACS |
Manufacturers should first determine, on the basis of the product composition, mode of action and intended use, whether a product is a medical device, a pharmaceutical product or a human tissue-related product in Hong Kong, so as to avoid selecting the wrong compliance pathway through an incorrect characterisation of the product.
2. Injectable and Infusible Medical Devices Must Be Listed Under MDACS
Under the Medical Device Administrative Control System, MDACS, introduced by the Department of Health in 2004, listing has historically been voluntary, and medical devices supplied in Hong Kong were required to meet the applicable safety, quality and performance requirements. The new requirement tightens this position from 1 March 2027: all injectable and infusible medical devices used in licensed PHFs must be listed under MDACS.
The requirement expressly covers:
• injectable dermal fillers;
• injectable mucous membrane fillers;
• all other injectable and infusible medical devices.
Practical effect. For manufacturers, MDACS listing moves from a commercial and procurement advantage to a condition for the product to be used in a licensed private healthcare facility.
3. Implications for the Medical Device Industry
Overall, the new requirement directly regulates the use of products in licensed private healthcare facilities and will have an indirect effect on the registration, procurement and supply of the relevant medical devices. Companies should use the transition period to complete their compliance preparation as early as possible.
| Stakeholder | Key Impact |
| Manufacturers and brand owners | Where an injectable or infusible medical device is intended for use in licensed private healthcare facilities in Hong Kong, MDACS listing should be completed as early as possible. |
| Importers and distributors | The listing status of each product must be verified, and valid evidence of listing provided to customers. |
| Licensed private healthcare facilities | Products in use should be reviewed to ensure that all relevant medical devices used from 1 March 2027 have completed listing. |
| Clinicians and procurement staff | Before use or procurement, the product name, model and manufacturer information should be checked for consistency with the MDACS listing information. |
| TRANSITIONThe requirement takes effect on 1 March 2027. The Department of Health advises licensed PHFs to liaise with product suppliers promptly to verify product compliance and to ensure that all injectable and infusible medical devices used in their facilities are listed under MDACS by the effective date. |