New regulations for medical devices are here
Favorable policies for innovative medical devices to enter hospitals and for medical devices to go global have arrived.
01
Innovative drugs and medical devices are included in the catalog
Hospitals “should allocate as much as possible”
On September 10th, the Guangxi Department of Industry and Information Technology issued the “Several Policy Measures on Promoting the High-Quality Development of Guangxi’s Biomedical Industry (Draft for Comments)” (hereinafter referred to as the “Draft for Comments”), which clearly specifies several measures to support innovative medical devices.
Among them, newly approved products and products that have entered the innovation channel will be supported with real money.
The “Draft for Comment” proposes that enterprises that newly obtain national drug or medical device registration certificates and achieve industrialized production will be supported in proportion to their registration classification and industrialization scale.
For innovative medical devices, after being approved for market launch, entering hospitals is a major challenge.
The “Draft for Comment” states that a “Catalogue of New and High-Quality Drugs and Medical Devices” will be formulated, which will include innovative drugs and medical devices, those that have achieved industrialization of key core technologies, and those with a certain level of advancement.
In addition, admission of “new and high-quality drugs and medical devices” to hospitals shall not be restricted on the grounds of the quantity of drugs used, the proportion of drugs/consumables, etc.
For innovative medical devices with high clinical value, supportive policies in the aspects of hospital admission and payment are of great significance, and it is expected that new technologies and products will be promoted at an accelerated pace.
02
Financial support to encourage equipment to go global
In addition to the supportive policies for innovative medical devices, the aforementioned documents in Guangxi also clearly put forward measures to encourage medical devices to go global.
The “Draft for Comment” proposes to encourage the exploration of foreign markets. For pharmaceuticals and medical devices that have obtained approval from institutions such as the FDA, EMA, and WHO, newly acquired overseas marketing qualifications, and are sold on a large scale in foreign markets, each registration document will be supported with no more than 300,000 yuan.
In addition, enterprises are encouraged to participate in well-known overseas exhibitions in the biomedical field, and support will be provided for the actual booth fees, exhibit transportation fees, personnel fees, etc. incurred by enterprises for participating in the exhibitions.
This year, cities such as Beijing and Shenzhen have also introduced similar measures to encourage Chinese medical device enterprises to go global.
“Several Opinions of Beijing Economic and Technological Development Zone on Promoting the High-Quality Development of the Pharmaceutical and Health Industry” proposes to support enterprises in applying for foreign registration and certification. For medical devices that obtain approval from institutions such as the FDA, EMA, CE, and PMDA for the first time, acquire overseas marketing qualifications, and achieve sales in relevant foreign markets, a one-time support will be given at a 1:1 ratio based on the actual sales volume.
Measures for Comprehensive Support for the Development of Pharmaceuticals and Medical Devices in Shenzhen proposes that preferential support will be given to medical device products that have been approved for marketing by the FDA, EMA, CE, etc., and have achieved sales. It supports key pharmaceutical and medical device enterprises in expanding their overseas businesses and encourages enterprises to establish overseas subsidiaries or carry out cross-border investment, financing, and mergers and acquisitions.
In recent years, there has been an upsurge in the export of medical devices. Many enterprises have identified overseas markets as an important source of growth and increased their investment and layout there.
According to a report by China Medical News, in the first half of this year, the total number of medical devices in China that obtained FDA certification reached 264, with the most products in fields such as general and plastic surgery, physical therapy, digestive and urinary, radiology, and cardiovascular.
Overall, the proportion of overseas business of leading medical device companies is continuously increasing, and the international influence of Chinese medical device companies is on the rise.
In the first half of this year, Mindray Medical’s international business grew by 5.39% year-on-year, and the proportion of international revenue has now increased to approximately 50%; United Imaging Healthcare’s overseas market revenue increased by 22.48%, with overseas revenue accounting for 18.99%; MicroPort’s overseas business revenue was 59.8 million US dollars, a year-on-year increase of 57.3%.
Some enterprises adopt differentiated overseas market strategies to promote the development of international business.
Yuwell Medical’s export revenue was 607 million yuan, a year-on-year increase of 26.63%, accounting for 13.03% of the total revenue.
The development of overseas markets has not been smooth sailing.
Previously, the glove business suffered a severe setback in the U.S. market. In terms of overseas business, INTCO Medical is rapidly advancing the layout of market diversification, deeply cultivating non-U.S. regions. In the first half of 2025, the sales revenue in overseas non-U.S. markets increased by approximately 45% year-on-year.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
By Dongtai
Source：Saibolan Equiradyknown
Translated & edited：Bradyknown
