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 National Medical Products Administration (NMPA) has approved 51 innovative medical devices year-to-date in 2026 and pledged to further accelerate review pathways for emerging technologies including brain-computer interfaces. In parallel, the National Healthcare Security Administration (NHSA) launched a nationwide pre-pricing pilot that initiates pricing evaluation before market authorization, aiming to compress the lag between NMPA approval and clinical reimbursement for innovative medical technologies.
In mid-September 2026, China's Center for Medical Device Evaluation (CMDE) opened public consultation on the revised Artificial Intelligence Medical Device Registration Review Guidance and a new clinical evaluation guidance for AI multi-disease assisted decision devices. Separately, the NMPA published YY/T 2029-2026, the world's first industry standard for AI-processed EEG datasets used in brain-computer interface (BCI) medical devices, effective September 1, 2027.
On September 20, 2026, NMPA Deputy Director Yang Sheng announced the 15th Five-Year Plan roadmap for innovative medical devices at a State Council Information Office press conference, revealing that 51 innovative medical devices have been approved year-to-date. The plan expands the 'Spring Rain Action' clinical-transformation program into frontier fields such as brain-computer interfaces, establishes market exclusivity for pediatric and rare-disease products, and explicitly encourages foreign manufacturers to produce high-end medical equipment domestically.
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.