Hong Kong authorities have made 2 important announcements within a matter of days relating to Hong Kong medical device listings:
- A new online platform for listing medical devices in Hong Kong was announced on March 28, 2024.
- Singapore marketing approvals will now be accepted in addition to other globally recognised approvals.
New Hong Kong Medical Device Online Platform
On March 28, 2024, the Hong Kong Medical Device Division (MDD) announced the launch of the Medical Device Information System (MDIS), an online platform for listing medical devices under the Medical Device Administrative Control System (MDACS). This system also allows for reporting safety alerts and adverse events for listed medical devices. The phased rollout of MDIS e-services will commence with the opening of online account registrations on April 2, 2024. Various application types will be progressively integrated until the final phase on October 14, 2024, when paper-based submissions will cease and be replaced entirely by online submissions.
Phased Rollout of E-Services to Online Submissions
To ensure a smooth transition, MDIS will roll out its e-services in phases, with key dates as follows:
- April 2, 2024: Opening of account registration
- April 15, 2024: Application for MDACS listing of medical devices and traders
- July 15, 2024: Processing change, takeover, and renewal applications
- October 14, 2024: Last day for paper-based submissions
Cisema is committed to providing comprehensive support to medical device manufacturers navigating the transition to online submissions. Contact our specialized team for help with clarifying application requirements or obtaining technical assistance for either or both paper-base and online-based submissions for Hong Kong medical device listing.
Why opt for Hong Kong MDACS listing?
Since the MDD’s announcement on October 17, 2023, prioritizing MDACS listing in the procurement of medical devices for Hong Kong public hospitals, there has been a surge in Hong Kong listing applications. Overseas manufacturers are increasingly seeking MDACS listing to meet the requirements for exporting to the China Greater Bay Area (GBA) from Hong Kong. If devices are approved for use in designated GBA medical institutions, then manufacturers may be able to collect real-world data (RWD) on local Chinese patients. Such RWD can serve as valuable clinical data in support of future NMPA applications, reducing the time to market for China-wide sales.
Singapore market approvals now accepted in Hong Kong
The MDD has announced the acceptance of market approval documents issued by Singapore’s Health Sciences Authority (HSA). This move fosters international collaboration and expands access to healthcare solutions for patients in Hong Kong public hospitals.
In the dossier submission process for Hong Kong listing applications, the MDD now recognizes the Health Sciences Authority (HSA) of Singapore among other regulatory agencies for market approvals, including:
- Mainland China (National Medical Products Administration)
- Australia (The Therapeutic Goods Administration)
- Canada (Health Canada)
- Member countries of the European Union that have implemented the European Council Directives or Regulations on medical devices
- Japan (Ministry of Health, Labour and Welfare)
- United States of America (U.S. Food and Drug Administration)
- South Korea (Ministry of Food and Drug Safety
Hong Kong listing applications may also qualify for expedited approval by the Hong Kong MDD, subject to specific criteria:
- The application must be submitted by an existing Local Responsible Person (LRP).
- No reported deaths or serious injuries associated with the device (both locally and worldwide).
- No active recalls, field safety corrective actions, or adverse events (both locally and worldwide).
- The device holds two or more marketing approvals from the mentioned regulatory agencies.
The expedited approval scheme streamlines the process for qualifying applications, enabling quicker market access for medical devices in Hong Kong.
Further information
The new developments mark significant advancement in streamlining medical device application submissions in Hong Kong. Embracing these changes enable manufacturers to improve efficiency and compliance in the regulatory approval process. At Cisema, we stay updated on Hong Kong regulatory changes and serve as the Local Responsible Person (LRP) for overseas manufacturers. Discover how our services support MDACS listing or contact us via email for inquiries, including drug registration in Hong Kong.
