Hong Kong Regulatory Updates: Additional Leveraged Country Authorizations and a Digital Platform

By Megan Gottlieb, Amber Baade and Evangeline Loh

The Hong Kong (HK) medical device regulatory system

Medical device makers who want to access the Hong Kong market must be aware of the latest regulatory requirements in this special administrative region of China. New developments in Hong Kong’s medical device market include additional leveraged country authorizations and a new digital platform.

The HK Medical Device Division (MDD) and the Medical Device Administrative Control System (MDACS) were established in July and November 2004, respectively. The MDACS is voluntary and modeled on the former Global Harmonization Task Force (GHTF), and now the International Medical Device Regulators Forum (IMDRF), and consists of a “collection of requirements designed to ensure the safety, efficacy and quality” of medical devices.

Although registration is voluntary, the HK Department of Health has a procurement policy that prefers registered devices. Only medium- and high-risk medical devices (Class II, III, and IV) and IVDs (Class B, C, and D) may be registered under the MDACS. Low-risk devices (Class I and Class A) cannot be registered even voluntarily. Authorization in a former GHTF member demonstrates compliance with some of these requirements. One aspect is compliance with the Essential Principles of Safety and Performance (GN-01).  

The HK MDD now accepts additional countries

Until recently, the U.S., EU, Canada, Australia and Japan were the only authorizations that could be used to demonstrate compliance with the Essential Principles of Safety and Performance and avoid the requirement for review by a Conformity Assessment Body in HK (GN-04).

At the start of 2024, the HK MDD announced (January 1) that effective on that date, marketing approvals from the China National Medical Products Administration (NMPA) and South Korea Ministry of Food and Drug Safety (MFDS) could also be used. Three months later, the MDD announced (March 28) acceptance of authorizations from the Singapore Health Sciences Authority (HSA).

New digital application system

The HK MDD launched (April 2) the Medical Device Information System (MDIS). The MDIS permits digital submissions of medical device and IVD applications and vigilance reports (safety alerts and adverse events). These features have a phased roll-in and a corresponding phase-out of paper submissions.  

The last date to submit medical device and IVD paper submissions is June 17. The complete phase-out for all paper submissions is October 14.  

Concluding remarks

With the addition of the NMPA, MFDS, and HSA, the MDD expands leveraged authorizations beyond the original GHTF founding members. This is aligned with the IMDRF 25^th annual meeting workshop on regulatory reliance.

Additionally, the MDIS is an exciting development and further facilitates digital initiatives, including global vigilance. As a Local Responsible Person, Emergo HK has already begun to access the system and is poised to use it as prescribed by the deadlines.