MDACS Listing: Key to Hong Kong Public Procurement and GBA Market Entry

Hong Kong is increasingly recognized as a critical gateway for MedTech products entering the Chinese market. Since its introduction in November 2004, the Medical Device Administrative Control System (MDACS) has been a cornerstone in promoting safe medical device use and preparing traders for future regulatory requirements. Recent regulatory updates in Hong Kong have heightened its importance, making MDACS listing even more crucial for public procurement.

New Regulations for Public Procurement

Here is an overview of the Hong Kong regulatory updates changing the public procurement processes:

Since June 21, 2023: Priority is given to MDACS-listed devices in public
From November 1, 2024: Preference will be granted to MDACS-listed devices for all quotations and tenders. All quotation exercises in the Department of Health (DH) will require that medical devices be either MDACS-listed or have a submitted listing application with an assigned number by the quotation closing time.
Estimated by 2025: All procured devices by the DH must be MDACS-listed.

Early application for MDACS listing is advisable to avoid potential application peaks expected until 2026.

Importance of MDACS Listing for GBA Market Entry

To enter the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) market successfully, obtaining a Hong Kong MDACS listing is increasingly essential. The GBA Connected Scheme, introduced by the National Medical Products Administration (NMPA) in November 2020, enables the use of Hong Kong-registered medical devices in the GBA.Devices that are already used or procured in Hong Kong public hospitals can be utilized in the GBA with Guangdong Province's approval. The Hong Kong Special Administrative Region (HKSAR) Government, in collaboration with the Guangdong Provincial Medical Products Administration (GDMPA), has implemented this policy. The initial trial at the University of Hong Kong-Shenzhen Hospital (HKU-SZH) ran from January to July 2021, and the policy was later expanded to include 18 other GBA healthcare institutions.For companies looking to enter the GBA market, securing an MDACS listing in Hong Kong is crucial. It not only meets regulatory requirements but also aligns with new procurement standards that prioritize devices listed in Hong Kong.

Further information:

Read the original announcement on Hong Kong Department of Health to implement a new strategy on procurement of medical devices.For companies aiming to enter the Hong Kong market, understanding and complying with MDACS is crucial. Cisema’s experienced team is ready to assist with these regulatory changes and support your market entry strategy. For inquiries or further assistance, please contact our expert team.