Hong Kong Requires MDACS Listing for Injectable Dermal Fillers by March 1, 2027

On September 9, 2026, Hong Kong’s Department of Health (DH), through the Office for Regulation of Private Healthcare Facilities (ORPHF), issued an “Update on Regulatory Requirements on the Use of Injectable and Infusible Products in Licensed Private Healthcare Facilities.” Endorsed by the Advisory Committee for Regulatory Standards for Private Healthcare Facilities, the update introduces clearer compliance requirements for injectable and infusible products used in licensed private healthcare facilities (PHFs).

The change is particularly relevant for manufacturers and suppliers of injectable dermal fillers, injectable mucous membrane fillers, and other injectable or infusible medical devices. From March 1, 2027, these products must be listed under Hong Kong’s Medical Device Administrative Control System (MDACS) when used in licensed PHFs.

For companies supplying injectable products into Hong Kong, now is the time to confirm product classification, check MDACS status, and address any gaps before the new requirement takes effect.

At a Glance

• New MDACS requirement: Injectable and infusible medical devices used in licensed PHFs must be listed under MDACS by March 1, 2027.
• Dermal fillers included: The requirement expressly covers injectable dermal fillers and injectable mucous membrane fillers.
• Three compliant categories: Products used in licensed PHFs must qualify as registered pharmaceutical products, compliant human organ/tissue products, or MDACS-listed medical devices.
• Further changes ahead: Revised Codes of Practice (CoPs) are expected to be gazetted in Q4 2026.
• Need support? Cisema can help medical device manufacturers and suppliers assess product classification, MDACS requirements, and regulatory readiness.

Regulatory Context

As private healthcare facilities increasingly use injectable therapies, biologics, fillers, regenerative products, and other advanced technologies, regulators have sought to strengthen oversight and ensure that products administered to patients meet appropriate safety, quality, and performance standards.

These products are regulated under different frameworks depending on their classification:

• Pharmaceutical products: Regulated under the Pharmacy and Poisons Ordinance (Cap. 138).
• Human organ and tissue products intended for transplantation: Subject to the Human Organ Transplant Ordinance (Cap. 465).
• Medical devices: Currently overseen through the voluntary Medical Device Administrative Control System (MDACS).

The latest DH update brings these requirements into clearer focus for products used in licensed private healthcare facilities, with the most significant changes affecting injectable and infusible medical devices.

A Clearer Regulatory Framework for Injectable Products

Under the updated requirements, injectable and infusible products used in licensed PHFs must fall into one of three regulatory categories:

1. Medical Devices: MDACS Listing Required

The most significant change concerns injectable and infusible medical devices.

From March 1, 2027, all injectable and infusible medical devices used in licensed PHFs must be listed under MDACS. This specifically includes:

• Injectable dermal fillers
• Injectable mucous membrane fillers
• Other injectable or infusible medical devices administered within licensed facilities

Healthcare facilities are strongly encouraged to verify compliance with suppliers as soon as possible and ensure affected products are listed before March 1, 2027.

2. Pharmaceutical Products: Existing Registration Requirements Apply

Products classified as pharmaceutical products must generally be registered with the Pharmacy and Poisons Board of Hong Kong before being supplied or used in Hong Kong.

Where an unregistered pharmaceutical product is imported for the treatment of a specific patient by a registered medical practitioner or dentist, the product may be exempt from registration requirements, provided that:

• The importation is supported by a valid import licence under the Import and Export Ordinance (Cap. 60)
• Appropriate procurement and import records are maintained by the healthcare facility

3. Human Organ and Tissue Products: Separate Controls Apply

Products containing processed human organs or tissues intended for transplantation purposes, such as certain skin graft or bone graft products, are regulated under the Human Organ Transplant Ordinance (Cap. 465).

Before clinical use, these products must either receive an exemption from the Director of Health or comply fully with the requirements of Cap. 465.

The DH also reminded stakeholders that transplantation procedures involving cells, tissues, or organs are subject to restrictions under the Private Healthcare Facilities Ordinance (Cap. 633), meaning certain procedures cannot be performed in clinics.

What Manufacturers and Healthcare Facilities Should Do Before March 2027

With revised CoPs expected in Q4 2026 and the MDACS deadline approaching on March 1, 2027, affected companies and healthcare facilities should begin reviewing their portfolios and compliance processes now.

Healthcare Facilities: Conduct Product Compliance Reviews

Licensed PHFs should review all injectable and infusible products currently in use to determine whether each product is regulated as:

• A pharmaceutical product
• A human organ/tissue product
• A medical device

Early product classification assessments will help identify potential compliance gaps before implementation.

PHFs should also strengthen procedures for:

• Supplier qualification
• Product verification
• Procurement documentation
• Import licence management
• Regulatory compliance monitoring

Maintaining comprehensive and traceable records will be important for demonstrating compliance during regulatory inspections and licence applications or renewals. Because compliance with the revised CoPs will be a condition for the issuance and renewal of PHF licences, gaps in product compliance could create operational and regulatory risks for healthcare providers.

Medical Device Manufacturers: Confirm MDACS Status

Manufacturers and local responsible persons supplying injectable medical devices should determine whether affected products are already listed under MDACS.

For products not yet listed, companies should consider initiating MDACS applications as early as possible to avoid potential market access disruptions before the March 2027 deadline.

Aesthetic Medicine and Dermal Filler Suppliers: Prepare for MDACS Listing

The explicit inclusion of dermal fillers and mucous membrane fillers signals increased regulatory scrutiny for aesthetic products used in healthcare settings.

Manufacturers and distributors should ensure technical documentation, quality management certifications, labelling, and supporting evidence are sufficient to support MDACS listing requirements.

Final Thoughts

The DH’s latest update marks an important step toward enhanced oversight of injectable and infusible products used in Hong Kong's private healthcare sector. While many of the pharmaceutical and human tissue requirements formalize existing legal obligations, the future requirement for all injectable and infusible medical devices to be listed under MDACS represents a significant development that manufacturers, suppliers, and healthcare facilities should prepare for now.

The transition to MDACS-listed injectable medical devices presents both a compliance challenge and an opportunity for manufacturers seeking long-term access to Hong Kong's healthcare market. Cisema's regulatory experts can help manufacturers, local responsible persons, distributors, and healthcare providers evaluate product classification, prepare MDACS submissions, and develop compliance strategies ahead of the March 1, 2027 deadline.

To assess your injectable medical device portfolio and prepare for the March 2027 MDACS deadline, contact Cisema today.

Further Information

• Explore Cisema’s Hong Kong Medical Device Listing Advisory Services

Reference

Update on Regulatory Requirements on the Use ofInjectable and Infusible Products in Licensed Private Healthcare Facilities