Hong Kong Medical Device Listing

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HONG KONG MEDICAL DEVICE LISTING

Hong Kong is a separate jurisdiction for the purposes of medical device and IVD market approvals and has its own unique regulatory system, the MDACS (Medical Device Administrative Control System). Unlike the mandatory registration requirements in China mainland, the listing of medical devices in Hong Kong is currently voluntary.

WHAT IS HONG KONG MDACS?

MDACS, established by the Hong Kong Government to enhance medical device safety and effectiveness, allows manufacturers and importers to list products and report adverse events. Both medical devices and In Vitro Diagnostic (IVD) products are classified into four risk levels under MDACS.

The Department of Health (DH) has implemented a procurement strategy effective June 21, 2023, prioritizing listed medical devices for procurement across all public hospitals in Hong Kong. Also, medical device products with listing approval opens opportunities for overseas medical device manufacturers to participate in the China Greater Bay Area "connect scheme".

WHAT ORGANIZATIONS ARE RESPONSIBLE FOR MDACS LISTING?

On 26.11.2004, the MDACS system was introduced by the Medical Device Division (MDD), formerly known as the Medical Device Control Office (MDCO), to raise public awareness on the safe use of medical devices and enable traders to familiarize themselves with the future mandatory requirements. The MDD operates under the Department of Health to develop a long-term statutory regulatory framework for medical devices based on the principles classified by the International Medical Device Regulators Forum (IMDRF).

The IMDRF, previously known as the Global Harmonization Task Force (GHTF), is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence. IMDRF members include Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea and the United States of America.

Greater Bay Area (GBA) Connect Scheme

Since November 6, 2019, this voluntary listing in Hong Kong has become much more attractive to overseas medical device manufacturers because with the Hong Kong listing, manufacturers may seek to take advantage of the Greater Bay Area “connect scheme”. This scheme permits products (medical devices, IVDs or drugs) that are urgently needed for clinical use and with no other similar product already for sale in China to be sold into certain hospitals within the southern China Greater Bay Area including Shenzhen, Guangdong, Zhuhai and a number of other large cities. The GBA region has a population size of around 80 million people.

As of January 2024, there are 19 Hong Kong-owned healthcare institutions participating in the connect scheme:

1. University of Hong Kong-Shenzhen Hospital
2. Modern Hospital Guangzhou
3. Guangzhou United Family Hospital
4. C-MER (Zhuhai) Dennis Lam Eye Hospital
5. Zhongshan Chenxinghai Hospital
6. The First Affiliated Hospital, Sun Yat-sen University
7. Sun Yat-sen Memorial Hospital, Sun Yat-sen University
8. Nanfang Hospital of Southern Medical University
9. Guangdong Provincial People's Hospital
10. Guangzhou First People’s Hospital
11. Clifford Hospital
12. C-MER (Guangzhou) Dennis Lam Eye Hospital
13. Shenzhen Qianhai Shekou Free Trade Zone Hospital
14. Shenzhen Hyzen Hospital
15. C-MER (Shenzhen) Dennis Lam Eye Hospital
16. The First Affiliated Hospital of Guangzhou Medical University Hengqin Hospital (former Zhuhai Hengqin Hospital)
17. Foshan Fosun Chancheng Hospital
18. Dongguan Songshan Lake Tungwah Hospital
19. Dongguan Guangming Ophthalmic Hospital

The Greater Bay Area consists of two SARs (Hong Kong and Macao) and nine Pearl River Delta municipalities in the Guangdong Province. China aims to build the Greater Bay Area into a hub of global technological innovation and an important source of emerging industries. For the past years, more and more medical institutions owned or managed by Hong Kong enterprises have been providing healthcare services in the Greater Bay Area.

Cisema can support you through the process of obtaining Hong Kong listing of your medical device or IVD through to pre-submission at Guangdong MPA to prepare for accessing the GBA connect scheme.

... and what added value does Cisema create for you?

Legal representation in Hong Kong as MDACS Local Responsible Person for registration and regulatory affairs
Application for listing medical devices under the MDACS
Avoid mistakes during your application process for MDACS listing, and benefit from our extensive years of experience and large client network.
With office locations worldwide, we are always at your disposal, mitigating effects of timezones and business hours.
Avoid unneccesary setbacks due to language barriers and cultural differences.
We maintain healthy long standing relationships with the Hong Kong authorities within the framework of our Code of Conduct.
We support you with our technical know-how and strive for seamless project progression within your timeline.
We will constantly keep you updated regarding changes to regulations, so you can stay one step ahead.