MDACS Listing Requirements for Injectable and Infusible Medical Devices
Since 2004, the Department of Health (DH) has operated the Medical Device Administrative Control System (MDACS) as a voluntary listing system to help ensure the medical devices supplied in Hong Kong meet applicable safety, quality, and performance requirements.
Under the updated requirements, the use of injectable and infusible medical devices in licensed PHFs will be subject to mandatory MDACS listing from 1 March 2027. The requirement applies to all relevant injectable and infusible medical devices, including:
- Injectable dermal fillers; and
- Injectable mucous membrane fillers.
The DH has also specifically included injectable dermal fillers and injectable mucous membrane fillers within the medical device definition under [GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System.
What Does This Mean for Manufacturers and Traders?
The new requirement is particularly relevant to manufacturers and traders supplying injectable or infusible medical devices to licensed Private Healthcare Facilities (PHFs) in Hong Kong. Before the effective date, manufacturers and traders should review the MDACS listing status of relevant products and determine whether an MDACS listing application is required.
The DH strongly advises PHFs to liaise with their product suppliers to verify compliance and ensure that all applicable injectable and infusible medical devices used at their facilities are listed under MDACS by 1 March 2027. For traders, the DH recommends the following actions:
- Liaise with the product manufacturer promptly, where applicable, to make arrangements for an MDACS listing application; and
- Inform customers, particularly licensed PHFs, of the MDACS listing status of the relevant products and support their transition to compliant products before the effective date.
Updated Codes of Practice
The DH will also revise the Codes of Practice (CoPs) applicable to private hospitals, day procedure centers, and clinics to incorporate the updated requirements. The revised CoPs are intended to be published in the Gazette in Q4 2026. The revised CoPs, except for the sections concerning injectable and infusible medical devices, will take effect one month after publication.
The specific requirement for the use of injectable and infusible medical devices listed under MDACS will take effect on 1 March 2027. Compliance with the applicable CoP is a condition for the issuance and renewal of PHF licenses.
How to Prepare for the 1 March 2027 MDACS Requirement
Manufacturers and traders supplying injectable or infusible medical devices to Hong Kong should consider the following steps:
- Review the product portfolio to identify injectable and infusible medical devices supplied to licensed PHFs;
- Check the current MDACS listing status of each relevant product;
- Determine whether an MDACS listing application is required;
- Liaise with the Hong Kong Local Responsible Person (LRP), where applicable, to prepare the listing application;
- Confirm that the product information and supporting documentation are consistent with the MDACS requirements; and
- Communicate the MDACS status and upcoming requirements to relevant PHF customers before 1 March 2027.
Early assessment is recommended to allow sufficient time for manufacturers and PHFs to address any products that are not yet listed under MDACS.
Apply now!
By reviewing the MDACS listing status of injectable and infusible medical devices early and preparing the necessary documentation, manufacturers and traders can support a smoother transition to the new requirements in Hong Kong. Qualtech provides regulatory support for medical device manufacturers, including MDACS classification, registration planning, technical documentation review, and regulatory compliance strategy. As the implementation date approaches, contact us to keep up with the latest regulatory requirements and prepare for the changes ahead.