The entry threshold for orthopedic forceps industry has been raised, and NMPA has strengthened registration review and supervision-Jiangsu Bazheng Medical Technology Co., Ltd.

The entry threshold for orthopedic forceps industry has been raised, and NMPA has strengthened registration review and supervision

Mar 30,2026

Summary: It is reported that by 2025, the entry threshold for the orthopedic forceps industry in China will significantly increase. The National Medical Products Administration (NMPA) will further strengthen the registration review and supervision of orthopedic forceps products. Only 19 new Class III orthopedic forceps registration certificates were added throughout the year, a decrease of 38.7% from 31 in 2024. This regulatory tightening mainly focuses on product safety, effectiveness, and clinical suitability, requiring companies to provide more comprehensive clinical evidence-based data and quality control system certification.

The entry threshold for orthopedic forceps industry has been raised, and NMPA has strengthened registration review and supervision
It is reported that by 2025, the entry threshold for the orthopedic forceps industry in China will significantly increase. The National Medical Products Administration (NMPA) will further strengthen the registration review and supervision of orthopedic forceps products. Only 19 new Class III orthopedic forceps registration certificates were added throughout the year, a decrease of 38.7% from 31 in 2024. This regulatory tightening mainly focuses on product safety, effectiveness, and clinical suitability, requiring companies to provide more comprehensive clinical evidence-based data and quality control system certification.
According to the "Classification Catalogue of Medical Devices" released by NMPA, orthopedic forceps cover multiple categories such as cervical bone biting forceps, nucleus pulposus forceps, and vertebral plate bone biting forceps, all of which must strictly comply with ISO13485 quality system certification and GB/T16886 series biological evaluation requirements. The regulatory authorities have made it clear that products that do not meet safety standards or have incomplete clinical data will not be approved. At the same time, they will increase the sampling intensity of products already on the market to regulate industry development.
Industry analysis points out that stricter regulation will accelerate industry reshuffle, and small and medium-sized enterprises without large-scale manufacturing capabilities and core technologies will face elimination. Top enterprises with independent research and development capabilities and compliant operations will gain more market share, promoting the industry's transformation towards high-quality development.

Technological innovation breakthrough, domestic intelligent orthopedic forceps achieve force feedback function in clinical trials

In 2025, the Chinese dual joint bone biting forceps market will experience steady growth, and the process of domestic substitution will accelerate

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