202601 | Decline in Dental Medical Device Registrations, Polymer Material Products Become Popular

Preface

Medical Device Registration data for oral care serves as a crucial reference point for observing the progress of domestic production and shifts in clinical demand structures. In January 2026, a total of 15 oral Medical Device Registrations were completed nationwide, representing a year-on-year decrease of 54.5% and a month-on-month decrease of 34.8%, placing the figure within a low range since January 2025. Influenced by the Spring Festival holiday and a periodic slowdown in approval pace at the beginning of the year, the overall decline in registration volume carries certain seasonal characteristics, making the structural data potentially more indicative of underlying trends.

Domestic products accounted for 12 registrations, representing 80.0% of the total, while imported products accounted for 3 registrations, or 20.0%. Analyzing the categories of imported registrations, all three imported products this month were concentrated in light-curing composite resins and basic dental burs. No registrations for Dental Implant systems or large-scale Digital Equipment were observed, indicating that imported registrations were primarily for mature restorative materials and basic surgical Consumables.

From a product structure perspective, bone filling and repair materials topped the registration list this month with 5 items, covering various bone substitute material systems such as calcium-silicate bioceramics and bioglass. Abutments and attachments followed with 3 registrations, spanning three levels: standard, composite, and Custom Abutment. Additionally, one registration was completed for an oral implant surgical navigation system, making it one of the relatively unique product categories on this month's list, belonging to the active device category integrating software and hardware.

Overall, the registration structure for January 2026 was dominated by products supporting implant restoration and bone repair materials, with Consumables-type products holding a relatively high proportion. A preliminary assessment based on this month's data structure suggests continuity with the overall trend observed in historical months.

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