October 12, 2020 — Hainan Province, China. This real-world data study of China clinical evaluation in the Hainan pilot zone will help urgent need medical devices.
For example, it allows the sale of certain imported medical devices and IVDs in China prior to national approval. This enables U.S. and European manufacturers more affordable and faster ways to access the 19% annual growth rate of the China MedTech market.
Conventional approval under China’s National Medical Products Administration (NMPA) can take years with clinical evaluation trials. But now, this new Hainan pathway can reduce time-to-market for initial clinical use to just months.
China Med Device
The program offers the most dramatic benefits for manufacturers of high-value and innovative devices, according to China Med Device (CMD), a consulting firm that helps companies gain access to the program.
“The Hainan Program provides significantly less burdensome alternative to the traditional clinical trials,” says CEO Grace Fu Palma of CMD.
Ms Li is the vice director of Hainan’s Lecheng NMPA office. She commented, “Qualified overseas manufactures can shorten the initial clinical use in clinical setting in China from years to just months. Manufacturers can quickly offer their products in real world clinical settings. They can also charge their normal service fees, and generate real-world data (RWD). That RWD serves as clinical evidence to later support national approval under NMPA.”
To qualify for the program, devices must be unapproved NMPA devices and show improvement over available devices or have no predicates in China. CMD works closely with manufacturers to determine which of their products meet the program’s qualifications and navigate the best approach.
Recent sessions at AdvaMed’s MedTech Conference and the RAPS Convergence, both chaired by Ms. Fu Palma, generated additional interest in the program.
The distinguished panel included Professor Sun Xin, the key advisor on RWD to NMPA. She spoke on the growing importance of real-world evidence, such as that generated from the Hainan Program.
Hainan Pilot Zone
CMD has set up a local office to best position itself to serve clients in the Hainan program.
“Just this year, we set up an office in Hainan to further strengthen relationships with local agencies and accelerate collaboration,” says COO Tony Liu of CMD. “My team has visited the latest pilot sites, met with local officials, and connected with key opinion leaders. Our goal is to network with experts and build unparalleled internal expertise, so we can give our clients the greatest chance to benefit under this program.”
Along with gaining quick market access while generating RWD, manufacturers under the Hainan program benefit from duty-free imports. In addition, they also gain access to sell directly into hospitals, and the ability to market products throughout China.
Mr. Gang Fu is the Chief of the Hainan Lecheng Pilot Zone Bureau. He said, “To accelerate Chinese patients benefit from using NMPA unapproved devices faster, overseas doctors can also practice in Hainan.”
To see if you are qualified for Hainan program, please call or email us at (978) 390-4453 or info@chinameddevice.com
About China Med Device, LLC (CMD)
CMD partners with medical device and IVD manufacturers at all stages of the product life cycle. We can help craft optimal regulatory, clinical, quality, and PMS solutions for products. For more information on this Hainan program: Hainan Real-World Data/Study
