Australian medtech pioneers accelerate China market entry through fast-track channels

Australian healthcare innovators are rewriting the rules of cross-border medical collaboration under China’s market access fast-track channels.

Historically, sophisticated foreign pharmaceutical and medical device companies faced a lengthy approval process of over 3 years to enter the Chinese market via registration with the National Medical Products Administration (NMPA).

Now, under the Hong Kong-Macao Drug and Medical Device Connect (Connect) policy, approvals can be streamlined to as fast as 40 days, enabling rapid access to the world’s second largest healthcare market.

The Connect policy, launched in 2021, allows Hong Kong- or Macau-registered drugs and devices to enter designated hospitals in the Guangdong-Hong Kong-Macau Greater Bay Area (GBA) without undergoing the national approval process.

By the end of 2024, 97 products—including drugs and medical devices—had been approved under this policy, benefiting over 8,000 patients across 45 designated hospitals in the 9 cities of the GBA.

Austrade encourages Australian pharmaceutical and medtech companies to harness these unparallelled opportunities. Austrade can support businesses to leverage this policy to accelerate their entry into China and deliver life-changing innovations to patients.

CSL: Protecting Rh-negative women from pregnancy complications

CSL, a global leader in biotech therapies, entered the Chinese market in 1986. The company is dedicated to expanding access to its innovative medicines to improve the quality of life of Chinese patients with rare and serious diseases. It is the leading supplier of imported albumin in China.

In August 2023, CSL brought its anti-D immunoglobulin to Hong Kong University Shenzhen Hospital under the Connect policy. Made from blood plasma, the treatment helps protect Rh-negative women from complications during pregnancy if their baby is Rh-positive. Without it, there could be risks like miscarriage, ectopic pregnancy or bleeding. To date, the treatment has benefited more than 1,800 pregnant women. By May 2024, use of the treatment had expanded to the First Affiliated Hospital of Sun Yat-sen University.

CSL commented that the policy has ‘unlocked immense potential to serve Chinese patients in need with the highest standards of care.

‘CSL greatly appreciates the opportunities provided by the Connect policy,’ says Jean-Marc Morange, CSL’s SVP & GM of Asia Pacific Commercial Operations. ‘It has enabled us to bring our life-saving therapies to patients in the GBA more quickly, enhancing our ability to serve the Chinese market effectively.’

Cochlear: Helping people with hearing loss

Australian medtech pioneer Cochlear is a world leader in implantable hearing solutions. Since its establishment over 40 years ago, the company has provided nearly 850,000 hearing devices in more than 180 countries and regions, helping people with hearing loss return to the world of sound.

Cochlear has been active in China since 1995 and holds a significant share of the implantable hearing device market. China is one of Cochlear’s top 5 markets; its innovative solutions have transformed the lives more than 50,000 Chinese patients with hearing loss. The company’s market share has been steadily increasing, thanks to the growing demand for hearing implants and its strategic investments in local manufacturing and research and development. 

Australian medtech companies at a roundtable on the Connect policy hosted by Austrade.

Cochlear became the first cochlear implant company to enter the GBA under the Connect policy. The company has deployed its products across 10 local hospitals in the GBA since 2023. These strategic accelerations, enabled by the policy, have delivered solutions to Chinese patients years ahead of traditional approval timelines. So far nearly 1,000 hearing loss patients have benefited from its cochlear implant systems, including the CI632 cochlear implant and the N8 sound processor.  

‘The Connect program has been a game changer for us,’ says Xinyu Li, General Manager of Cochlear China. ‘It enables us to bring life-changing solutions to Chinese patients faster than the traditional pathway, providing them with quality healthcare resources, Cochlear’s globally synchronised advanced products, and world-class service.’

Hainan Boao Lecheng Pilot Zone 

Introduced in 2018, the Hainan Boao Lecheng International Medical Tourism Pilot Zone is another fast-track channel. It allows foreign medical products to be used in Hainan without prior national registration, significantly expediting access to the Chinese market. 

Australian firms, including Capricornia, Cochlear, Sirtex and Clinuvel, have successfully entered the Chinese market through this channel, meeting urgent clinical needs and saving thousands of lives.

‘Since 2018, Cochlear was among the first batch of enterprises stationed in Boao,' says Mr Li. 'Leveraging the policy advantages of the Pilot Zone, Cochlear has launched more than 10 internationally leading products including cochlear implants, bone conduction implantable hearing systems and brainstem auditory implant technologies. These innovations have empowered nearly 6,000 people with hearing loss to hear the world and enjoy a wonderful life.’

Cochlear has also conducted 3 real-world data research projects in cooperation with medical institutions and domestic clinical experts in the Pilot Zone. Two of the completed projects have helped the related products to obtain regulatory approval from the National Medical Products Administration (NMPA).

By 31 December 2024, the Pilot Zone has brought in more than 450 drugs and medical devices, benefiting more than 100,000 patients.

Seventeen of the products have received NMPA approval and registration with the assistance of Lecheng real-world clinical trial data. Two of those products are listed in the national catalogue of medicines covered by insurance. So far, 36 medical institutions have been established in Lecheng. The use of approved drugs and medical devices in Lecheng has reached 51,300 people, with a year-on-year increase of 79.18%.

Empowering Australian businesses 

The fast-track initiatives offer Australian companies a pathway to China’s rapidly evolving healthcare market. As China intensifies its focus on healthcare innovation, the GBA is a gateway to a market poised for exponential growth.

Austrade can support Australian companies to navigate the complexities of the Chinese market, capitalise on the fast-track policies and the opportunities in the GBA market, and bring cutting-edge solutions to Chinese patients.