FDA Breakthrough Device v.s. NMPA Innovative Medical Device

Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

Cumulative inclusion of 760 models but only approved 62 for marketing, FDA set up lenient entry and strict exit for "breakthrough devices"

From 2015 until December 31, 2022 (devices previously included by EAP program are also counted by FDA), a total of 760 medical devices have been included on the list of breakthrough devices. Of these, all but 8 were approved by the CBER (Center for Biologics Evaluation and Research), which oversees biologics, and the remaining 752 were approved by the CDRH, which oversees medical devices and digital health.

Breakthrough devices can be divided into 20 fields. The largest number of breakthrough devices is in the cardiovascular field, with 171 devices over the years. The next largest number of breakthrough devices is in the neurological field, with 137 devices. This was followed by orthopedics (87), gastroenterology (60) and orthopedics (53).

The cumulative number of breakthrough devices in these five fields reached 508, accounting for 66.8% of the total. This represents the main direction and top trend of worldwide medical device innovations.

However, although the list of selected devices seems to be long, but only a few of them were actually approved for marketing. From 2015 to date, 62 breakthrough devices have been approved for marketing by FDA, with a pass rate of only 8.9%.

China's medical device innovation still has room for improvement when compared to the global advanced level

From the approval of innovative medical devices in both countries, it is easy to see that China's medical device innovation still has room for improvement, but the rapid development momentum in recent years is also an indisputable fact.

Compared with the approvals of FDA's breakthrough devices and NMPA's innovative medical devices, FDA is more "lenient in and strict out". Although the number of devices included on the list over the years is very large, but only 8.9% came to the final market application.

In contrast, China's innovative medical device approval is different. According to the summary statistics over the years, the percentage of adoption in this step of being approved to enter the innovative medical device program is about 21%, but the percentage of successfully getting the medical device certificate after entering the innovative medical device approval process is as high as 51%. If combined with the local bureaus of the 2 types of innovative medical devices, the adoption rate may be even higher.

It also reflects the gap between China's medical device innovation and the global top level one, including the investment in R&D, scientific research transformation, strengthening of basic science and even the subsequent further productization and commercialization. China's medical device innovation still has quite a long way to go.