Author: Jenny Lin
In June 2019, China accepted a new initiative proposed by the Hong Kong Special Administration Region (SAR) to allow the sale of Hong Kong-registered medical devices and drugs to Hong Kong-owned medical institutions within the Greater Bay Area (GBA) without prior NMPA registration.
The GBA consists of the two Special Administration Regions of Hong Kong and Macao, and the nine municipalities of Guangdong Province: Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing.
In November 2020, this initiative was put into action through announcement (No. 159, 2020) of the State Administration for Market Regulation (SAMR). With a GDP of over US $1,670 billion and a population of more than 72 million in the GBA, which is close to the size of Germany, this plan forms an expedited and cost-effective market entry opportunity for biotech companies who are seeking to expand their business to the Mainland China.
China requires Class II and Class III devices to be tested in an NMPA accredited laboratory in China prior to product registration. Most Class II and Class III devices (Class III being the highest risk) also require local clinical study data to be part of the submission dossier (unless the product is on the NMPA clinical trial exemption list). These two unique requirements often translate to high costs and a lengthy process, typically two to three years when a clinical trial is involved.
Hong Kong registration
Hong Kong currently has a voluntary registration system called “Medical Device Administrative Control System (MDACS)”, where the registration only requires a set of minimum documents, such as MDACS form, ISO 13485 certificate, Instructions for Use, testing reports generated in the home country, and a summary of available clinical data. As neither local type testing nor clinical trials are required, both the preparation and assessment period are much shorter than what would be expected for a Chinese NMPA application.
Benefits for manufacturers
As the new policy allows foreign manufacturers to sell Hong-Kong registered products to eligible medical institutions in the GBA, manufacturers can benefit from a much faster and simplified regulatory process for market access to one of the fast-growing regions in China.
In addition, NMPA published draft guidance in accepting real-world data which, if not changed significantly prior to implementation could allow clinical data generated for devices used in the GBA to be leveraged for a later NMPA registration.
As per the SAMR action plan (No.159, 2020), the eligible applicants will be designated medical institutions in the GBA. As such, manufacturers that are interested in this new policy need to work with local hospitals on their application:
- The GBA medical institution must be a healthcare service provider from Hong Kong or Macao in the form of a sole proprietorship, joint venture or cooperation in the GBA, and they must be designated by the Guangdong Health Commission.
- The University of Hong Kong Shenzhen Hospital is the first designated site to run the pilot test. The policy will extend to more medical institutes in the GBA. Refer to the list of medical institutes owned or managed by Hong Kong entities in the GBA.
Upon receipt of an application, the Guangdong Health Commission and the Guangdong FDA will jointly assess the device eligibility based on whether:
- the device meets a clinically urgent need and there is no alternative treatment method;
- there are currently available devices in China which can achieve the same treatment efficacy (technological advancement in clinical applications); and
- the device has been procured and used in Hong Kong (or Macao) public hospitals.