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In the height of summer, on Lüdao Island, guests feel right at home. On June 30, against the backdrop of deepening medical cooperation between China and Indonesia under the Belt and Road Initiative and the RCEP framework, a medical delegation from the Indonesian government visited Xiamen. As a leading enterprise deeply rooted in the fields of medical devices, medical consumables, medical equipment, diagnostic reagents, and the global healthcare supply chain, our company was invited to engage in in-depth exchanges and discussions with the delegation, jointly exploring new avenues for industry collaboration.
When the epidemic struck, government and enterprises joined forces, demonstrating their sense of responsibility through mutual support and solidarity; we delved deeply into fertile ground to usher in a new chapter. Looking back at the critical period of epidemic prevention and control, Dehua County faced an urgent shortage of防疫 supplies, leaving many medical companies unable to provide adequate support. In this moment of crisis, our company stepped forward, proactively reaching out to the Dehua County government. With a strong sense of social responsibility and highly efficient supply-chain integration capabilities, we fully committed ourselves to ensuring the supply of防疫 materials.
In 2023, many areas in Gansu Province were hit by severe flooding. The raging floods not only destroyed homes but also created hidden public health risks by spreading bacteria and viruses after the disaster. Though disasters are merciless, humanity remains compassionate. At this critical moment when epidemic prevention efforts in the affected areas are urgently needed, our company, guided by our original commitment to "medical care for the people and a sense of responsibility," proactively responded to the epidemic prevention needs of the disaster zone. We promptly allocated supplies and donated a batch of specialized protective suits to the flood-hit regions in Gansu, thereby establishing a strong safety barrier for frontline epidemic prevention workers in the aftermath of the disaster.
From June 8 to June 10, 2023, the Shenzhen International High-Performance Medical Device Exhibition was held with great success. ThinkMed Medical participated in several thematic seminars and forums at the exhibition, joining industry peers to discuss trends in the AI-driven healthcare sector and sharing its own innovative product applications as well as achievements in international expansion.
A Review of the Latest Globally Approved Medical Devices in May
Release time:
2023-06-08
(1) U.S. FDA Approval Status
As of June 8, 2023, the FDA approved a total of 267 products via the 510(k) pathway in May, including 15 Class I devices, 246 Class II devices, and 6 unclassified devices.
By categorizing devices submitted via 510(k) premarket notifications according to their intended medical use in the United States, we found that, in May, the device types with the highest number of approvals were orthopedic devices, radiology devices, general and plastic surgery devices, cardiovascular devices, and devices for general hospital and personal use—see Figure 4.
Figure 4: Distribution of Product Types Approved for Market Launch via the FDA 510(k) Pathway in May 2023
Source: U.S. Food and Drug Administration
In May 2023, three products were first launched via the Pre-Market Approval (PMA) pathway.
Table 4: Devices First Approved by the PMA in May 2023
Source: U.S. Food and Drug Administration
(2) Approval Status within China
As of June 8, 2023, in May 2023, the National Medical Products Administration announced that four Class III medical devices had been granted access to the innovative approval green channel, as shown in Table 5.
Table 5: Three Categories of Innovative Devices That Entered the Green Channel in May 2023
Source: National Medical Device Review Center
As of June 8, 2023, the National Medical Products Administration announced in May 2023 the approval for market launch of three Class III innovative medical devices, as shown in Table 6.
Table 6: Class III Innovative Medical Devices Approved for Market Launch in May 2023
Source: National Medical Device Review Center
As of June 8, 2023, in May 2023, the National Medical Products Administration approved a total of 185 first-time registrations for Class III medical devices, including 156 domestically produced and 29 imported devices. In May, provincial drug regulatory authorities approved a total of 771 registrations for domestically produced Class II medical devices and 2,143 filings for Class I medical devices.
Statistical data show that in vitro diagnostic reagents account for the largest number of items, totaling 1,040, or 33.56%. Virtually all of these reagents—1,027 items—are domestically produced. Aside from in vitro diagnostic reagents, the top three categories approved for registration are infusion and injection devices, nursing and protective devices, passive surgical instruments, and dental instruments.
Table 7: Distribution of the Number of Approved and Registered Categories for Domestic and Imported Medical Devices in May
Source: National Medical Device Review Center
In terms of geographical distribution, in May 2023, the regions with the highest number of approved domestic Class II and Class III registered products were, in order: Jiangsu Province (168 cases), Guangdong Province (139 cases), and Beijing Municipality (94 cases), as shown in Figure 5.
YESING (Xiamen) Biotechnology Co., Ltd.
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