Navigate Global Regulations with Confidence
The regulatory landscape for medical devices is complex and continuously evolving. SGO Medical's regulatory affairs team provides comprehensive consulting services to help manufacturers achieve market clearance in major global markets efficiently and compliantly.
Services by Market
- United States (FDA): 510(k) premarket notification, De Novo classification, PMA submissions, establishment registration, and MDR/MAUDE reporting
- European Union (CE): MDR 2017/745 compliance, technical file preparation, clinical evaluation reports, post-market surveillance plans, and Notified Body liaison
- China (NMPA): Class I/II/III device registration, clinical trial management, type testing coordination, and annual reporting
- Other Markets: Health Canada, TGA (Australia), PMDA (Japan), ANVISA (Brazil), KFDA (South Korea)
End-to-End Support
From initial product classification and regulatory strategy development through submission preparation, agency correspondence, and post-market compliance, our team guides you through every step of the regulatory journey. Our average 510(k) clearance timeline is 4.5 months from submission — well below the industry average of 7+ months.