Hong Kong Introduces Measures for Priority Approval of Innovative Medical Devices

On June 12 2026, Hong Kong's Medical Device Division (MDD) updated Guidance Note "GN-02" for Class II, III, and IV General Medical Devices, as well as Guidance Note "GN-06" for Class B, C, and D In Vitro Diagnostic Medical Devices (IVDMDs). Effective immediately, the revised guidance added new Section "E001", allowing applicants to request priority consideration for qualifying "innovative medical devices" under the Medical Device Administrative Control System (MDACS).

The update signals Hong Kong's continued commitment to supporting innovation in healthcare and provides manufacturers with a new opportunity to accelerate market access for eligible technologies. It also reinforces Hong Kong's position as an increasingly important gateway for advanced medical technologies entering the Greater Bay Area and broader Asia-Pacific region.

At a Glance:

• Updated Guidance Notes "GN-02" and "GN-06" introduce priority consideration for qualifying innovative medical devices
• New Section "E001" establishes four eligibility pathways for innovative medical devices
• Revised application requirements require additional information and supporting evidence
• Priority consideration is available for both general medical devices and in vitro diagnostic medical devices
• Existing regulatory approvals, AI-enabled technologies and recently granted patents may support eligibility

The Regulatory Shift Toward Innovation

In recent years, regulatory authorities globally have sought to encourage innovation through dedicated review programs and innovation pathways. Examples include the FDA's De Novo pathway in the United States and China's innovative medical device pathway managed by the National Medical Products Administration (NMPA).

Hong Kong is aligning with this global momentum. By recognizing breakthrough technologies, prioritizing their review under MDACS, and explicitly accommodating AI-based devices, the region is accelerating regulatory acceptance of digital healthcare innovations and signaling a modernized framework for health tech.

Although MDACS remains a voluntary registration framework administered by the MDD under the Department of Health, obtaining MDACS listing is widely recognized as an important market access step. Healthcare institutions, procurement organizations, and business partners often consider MDACS listing a key factor when evaluating medical device suppliers.

Four Pathways to Priority Consideration

The revised guidance allows manufacturers to request priority consideration as part of an MDACS listing application. To qualify, a device must satisfy at least one of four innovation criteria:

1. First-of-Its-Kind Technology: The device incorporates a unique technological feature for which no equivalent product currently exists on the market.
2. Approval Through Recognized Innovation Channels: Secured marketing authorization within the past five years via programs such as the NMPA Innovative Medical Device Program (創新器械名錄), the U.S. FDA De Novo pathway, or other MDD-recognized channels.
3. AI-Enabled Medical Devices: Devices incorporating artificial intelligence (AI) functionality may qualify if they have received market authorization within the previous five years.
4. Recently Patented Core Technology: Devices whose core technology is protected by a patent granted within the previous five years may also qualify for priority consideration.

Demonstrating Eligibility

Manufacturers requesting priority consideration must provide sufficient information and supporting evidence to demonstrate that their device meets the relevant innovation criteria.

Applicants must:

• Select the relevant qualifying criterion or criteria within the application form
• Provide a comprehensive description of the innovative features
• Submit supplementary supporting information and documentary evidence consistent with information submitted in Parts C and D of the listing application

Supporting documentation may include comparative technology assessments, patent documentation, regulatory approvals obtained through recognized innovation programs, and AI-related regulatory clearances.

Key Implications for Manufacturers

A key advantage under the revised guidance is the recognition of innovation credentials established in other major markets. By acknowledging existing innovation credentials, the MDD enables companies to capitalize on prior regulatory and R&D investments rather than developing entirely new evidence to demonstrate innovation. This approach may reduce duplication, improve submission efficiency, and strengthen the overall business case for entering the Hong Kong market.

Beyond the immediate regulatory benefits, these changes also influence broader regional market access strategies. As Hong Kong continues positioning itself as a regional hub for healthcare innovation, alignment with internationally recognized regulatory pathways enhances the strategic value of an MDACS listing. Companies may use MDACS registration as part of a coordinated market access strategy targeting the Greater Bay Area and the wider Asia-Pacific region.

To make the most of this opportunity, manufacturers should assess their product portfolios to determine whether existing innovation credentials may support eligibility before preparing an MDACS submission.

Final Thoughts

The addition of innovative medical device criteria to MDACS Guidance Notes GN-02 and GN-06 represents a meaningful advancement in Hong Kong's medical device regulatory framework. By providing priority consideration for first-of-its-kind technologies, AI-enabled devices, products approved through recognized innovation pathways, and recently patented technologies, the Medical Device Division is creating incentives for manufacturers to bring innovative healthcare solutions to the Hong Kong market.

For medical device manufacturers, the opportunity lies in leveraging innovation credentials to potentially streamline regulatory review. Cisema can help assess eligibility, develop supporting justification packages, prepare MDACS listing submissions, and navigate regulatory interactions to maximize the benefits of this new pathway.

Interested in bringing innovative medical technologies to Hong Kong? Contact Cisema today to discuss your MDACS listing strategy and regulatory pathway.

Further Information

• Explore Cisema’s Hong Kong Medical Device MDACS Listing Services
• Explore Cisema’s Hong Kong IVD MDACS Listing Services

References

• Hong Kong Medical Device Division, Guidance Notes for Listing Class II/III/IV General Medical Devices (GN-02), updated June 12 2026
• Hong Kong Medical Device Division, Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices (GN-06), updated June 12 2026