Data | NMPA Approvals for Dental Implants Increased 30.8% YoY in 2025, Straumann Secured 12 Certificates

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Recently, GoodNews DataLab released the '2025 Oral Medical Device Registration Panoramic Report'. The data shows that the total number of oral medical device registrations in 2025 was 319, a year-over-year increase of only 1.3%. Meanwhile, the proportion of domestic registrations decreased by 2.5 percentage points to 71.2%, while the proportion of Class II devices among imported products jumped 7 percentage points to 48.9%. These changes collectively point to one judgment: the industry has shifted from 'incremental competition' to a more complex stage of 'stock competition'.

I. Adjustment of Import Strategy: Surge in Class II Proportion to Address Market Uncertainty

Against the backdrop of minimal total volume growth, changes in the structure of imported products are particularly noteworthy. In 2025, the number of imported Class II device registrations increased from 33 to 45, with the proportion jumping from 39.8% to 48.9%, nearly splitting evenly with Class III devices. This reflects that imported companies are adjusting their registration strategies in China, tilting toward Class II products with shorter approval cycles and higher market access certainty. This strategic downshift is closely related to companies' needs for cost control and flexible response to market changes in the volume-based procurement environment.

II. Differentiation of Track Performance: Dental Implants 'Intensely Competitive', Mature Categories Consolidating

The performance of subdivided tracks further confirms the intensity of 'stock competition'. The dental implant track has become a clear 'red ocean': registrations surged 30.8% to 51, with as many as 40 participating companies, indicating fierce competition. In sharp contrast, registrations for the traditional largest category abutments and accessories decreased 9.5%, with 10 fewer participating companies, as the market undergoes natural consolidation. Additionally, although oral burs/drills achieved a 250% ultra-high growth rate, all 14 registrations came from imports, revealing that technical barriers in specific fields remain solid.

III. Diverging Enterprise Paths: Differentiated Competition Between Local Supporting Products and Foreign Core Products

The investment maps of domestic and imported companies clearly show two different competitive paths. Domestic companies are fully strengthening their layouts in supporting fields such as orthodontic implant anchorage, oral X-ray machines, and implant auxiliary materials, leveraging supply chain and cost advantages to build moats. Imported companies continue to focus on core high-value consumables such as dental implants, etchants, and burs/drills, consolidating their technical brand advantages. This differentiation between 'supporting' and 'core' defines the two main survival logics in the current market.

IV. Increased Landscape Fluidity: Rise of New Forces Foreshadows Future Battles

Changes in the landscape of leading companies add greater suspense to future competition. Straumann (Shanghai), FIMS, Hiossen, and other companies that were not on the list last year or ranked lower have strongly entered the top ten in registrations in 2025. At the same time, registration numbers for some traditional leading companies have declined. This indicates that the market is far from consolidated, and new and old forces are re-competing on the same stage. Especially in the most crowded dental implant track, the combined registration volume of the TOP10 companies accounts for only 41.2%, foreshadowing that in the next 2-3 years, the risks of price wars and homogenization competition are accumulating, and industry consolidation may accelerate.