From NMPA registration to omni-channel e-commerce and 3,000+ O2O stores — we deliver a complete go-to-market engine for overseas medical device brands entering China.
Numbers we deliver month after month for our partners.
Two tightly integrated practice areas that let you move from regulatory approval to revenue without juggling multiple vendors.
We handle the full NMPA lifecycle — so you don't have to.
Turn an approved product into a China-wide revenue stream — fast.
Client names are confidential under NDA. Below are representative, fully anonymized engagements across our core practices.
* Brand names protected under non-disclosure agreements.
Listed Nordic medical device manufacturer, 40+ years in diabetes care
Family-owned German precision manufacturer, 25+ years in implantology, CE-marked, FDA 510(k) cleared
Japanese listed rehabilitation equipment brand, #2 market share domestically in Japan
US-based Silicon Valley beauty-tech startup, Series B funded, already sold in 18 countries via direct-to-consumer
Fresh regulatory and market intelligence from China's medical device landscape — updated daily by our team.
China's Center for Medical Device Evaluation (CMDE) released updated technical guidance for Class II medical device registration, introducing a streamlined documentation pathway expected to reduce average review timelines by 20-30%.
New industry data shows China's medical device online-to-offline (O2O) retail channel reached ¥18.4B in H1 2026, with the Xiaoxiang platform network expanding to over 12,000 connected retail pharmacies nationwide.
We built our practice specifically to solve the two hardest problems for foreign medical-device brands in China.
A 50+ in-house regulatory team with former NMPA reviewers and hospital medical-affairs staff.
Direct integration with 3,000+ retail pharmacies and specialty stores — most agencies can't match this reach.
¥40M+ monthly GMV across our operated portfolios. Our financials are auditable for partner due diligence.
In-house medical copy, short-video and KOL teams — every output passes a compliance reviewer.
From first NMPA meeting to 10M RMB monthly SKU sales — one team, one P&L, no hand-off loss.
Transparent, milestone-based. No black boxes.
We review your product dossier, category and goals — deliver a no-obligation feasibility report within 5 business days.
Phased roadmap with clear milestones, timelines and fees. Regulatory and distribution modules can start independently.
Dedicated project manager, weekly reports, client portal. You always know exactly where things stand.
After launch, continuous A/B testing, channel expansion and revenue optimization. We grow as you grow.
“We had tried two other CROs before Okeyplus and wasted 14 months. They got us through NMPA Class II registration in 7.5 months and launched on Tmall within the same quarter.”
“Their Xiaoxiang O2O network is real. In month 3 we were already seeing more revenue from offline retail than from our flagship JD store. Nobody else pitched us that channel.”
“The content team understands medical compliance. Every script, every KOL brief is medically reviewed before it goes out. That alone saved us from at least three platform takedowns.”
Tell us a bit about your product and goals. We'll reply within 1 business day with a concrete next step.