Table 6.
Global regulatory pathways for AI-navigated shoulder injection systems.
| Regulatory authority | Certification category | Core requirements | Approved cases | References |
|---|---|---|---|---|
| NMPA (China) | Class III Medical Device | Accuracy (success rate ≥90%); 3-center clinical validation (≥100 cases); data security (GB/T 35273–2023) | Joint VTS (Reg. No. 20243010705); Tianzhihang System | Xu et al. (2025) |
| FDA (USA) | SaMD (510(k)/De Novo) | Substantial equivalence; real-world surveillance (12 months); AI/ML change control plan | ExactechGPS® (510(k) cleared) | Xu et al. (2025) and Velasquez Garcia and Abdo (2023) |
| EU MDR (EU) | Class IIb Medical Device | MDR 2017/745 compliance; risk management; periodic revalidation (2–5 years); predictable learning for adaptive AI | Tianzhihang System (CE marked) | Xu et al. (2025) |
| MHRA (UK) | Class IIb Medical Device | UKCA marking; MDR-aligned risk management; AI update triggers; MRA with US/FDA | ExactechGPS® (MRA-recognized) | Xu et al. (2025) |