Taking Health Companies
Global.
Nexiv Global connects health and wellness companies with former CFDA review experts, clinical nutrition scientists, and AI-powered compliance tools — to enter China, or take Chinese brands global.
Two Directions. One Platform.
Choose your direction — we handle the regulatory complexity on both sides.
Entering China
Navigate NMPA registration, Blue-hat compliance, and China market entry with a team that has worked inside China's regulatory review process for decades.
Going Global
Take your Chinese health brand to the US and international markets. FDA compliance, entity setup, and channel entry — guided by specialists on both sides.
Start Here.
No Commitment Required.
The lowest-barrier way to access our expertise — before committing to a full engagement.
1-on-1 Regulatory Strategy
Direct access to our specialist network. Bring your NMPA, FDA, or compliance questions and leave with a clear, actionable path forward.
- NMPA / FDA pathway clarification
- Product classification & registration strategy
- Go-to-market regulatory planning
- Written summary & action items after each session
- AI-prepared pre-session brief included
No minimum. Book only what you need.
Schedule a Session →
Health & Wellness Market Monitor
Monthly AI-monitored, expert-curated briefing on NMPA and FDA regulatory changes that affect health, nutrition, and medical device companies.
- China NMPA policy updates for your product category
- US FDA / FTC regulatory developments
- Cross-border compliance alerts
- Market opportunity signals
Find Your Track.
Select your direction. All pricing is transparent — click any service to enquire and we'll send you a service agreement within 24 hours.
- Device classification determination
- Registration vs. filing pathway
- Timeline & cost projection
- Technical documentation checklist
- 1 × expert strategy session (60 min)
- Technical file preparation
- Registration execution
- Everything in Tier 1
- Full technical file framework
- NMPA compliance gap analysis
- AI-assisted document review
- Authorized agent shortlist
- 3 × expert sessions
- Registration filing & submission
- End-to-end NMPA registration management
- Full dossier preparation & translation
- NMPA submission & direct liaison
- Testing lab selection & coordination
- Authorized agent coordination
- Unlimited expert access throughout
- Product classification (food / health food / drug)
- Regulatory pathway determination
- Import feasibility assessment
- Labeling requirements overview
- Label compliance review
- Registration support
- Everything in Tier 1
- Detailed label compliance review
- AI-powered ingredient compliance check
- Blue-hat (保健食品) registration pathway
- GACC registration assessment
- Marketing claims compliance review
- 2 × expert sessions
- Blue-hat application preparation
- NMPA food registration coordination
- Label design compliance sign-off
- Complete import documentation package
- Distributor vetting support (optional)
- Ongoing compliance monitoring
US Supplement Compliance Assessment
FDA dietary supplement compliance evaluation, cGMP gap analysis, and label & marketing claims review under FDA and FTC guidelines.
FDA Registration & cGMP Compliance
FDA facility registration coordination, cGMP compliance roadmap, and documentation preparation for dietary supplement manufacturers.
US Entity & Market Setup
Entity structure recommendation, state selection strategy, coordination with vetted US legal and accounting partners, and banking setup guidance.
US Channel Entry Briefing
Amazon, iHerb, and Thrive Market entry requirements, 3PL recommendations, and retailer compliance documentation overview.
Expanding soon
Practiced at the
Highest Levels.
"Access to this team is rare. Our advisors didn't study regulatory systems from the outside — they built and operated them."
Nexiv Global is a hand-selected advisory platform, not a generalist consulting firm. We assemble the right senior specialists for each engagement, drawing on careers spent at the apex of government regulatory bodies, world-class research institutions, and international health markets.
Every client receives direct access to principals — not analysts, not associates. The people who answer your questions are the same people who have spent decades evaluating the submissions you're preparing to file.
Our network includes US-based regulatory affairs specialists engaged on a per-project basis, ensuring both sides of every cross-border engagement are covered at the senior level.
Former CFDA Senior Review Specialists
Among our advisors are individuals who served as senior review specialists within China's national pharmaceutical and device regulatory authority — having personally evaluated thousands of NMPA submissions at the highest level of the review process. They know precisely what regulators scrutinize, and why applications succeed or fail.
Clinical Nutrition Scientists — 40+ Years in Practice
Our nutrition science advisors bring over four decades of combined clinical practice, supplement formulation expertise, and regulatory science experience. They have guided brands from pre-market development through post-market surveillance, across both Chinese and international health food regulatory frameworks.
Practitioners from Leading AI Research Institutions
Our technology advisors bring experience from frontier AI research environments, applying rigorous methodologies to compliance document analysis, regulatory monitoring, and process acceleration — making our engagements faster and more defensible than traditional approaches.
US Regulatory Affairs & Market Specialists
FDA, FTC, and channel specialists based in the US ensure our clients receive locally calibrated, senior-level guidance on the American side of every engagement — not advice filtered through intermediaries unfamiliar with the US regulatory environment.
China Outbound & Globalization Specialists
Our globalization advisors have guided Chinese health and wellness brands through the full arc of international expansion — from entity setup and supply chain localization to retail channel entry, Amazon launch, and brand positioning in Western markets. They bridge the cultural and commercial gap that pure regulatory expertise cannot cover.
Smarter Compliance.
Coming Soon.
We're building AI tools to make regulatory compliance faster and more accessible. Join the waitlist for early access.
AI Compliance Scanner
Upload product specs. Receive an instant preliminary compliance assessment for China NMPA or US FDA requirements.
AI Label Review
Submit your product label draft. Receive a compliance-marked version with specific corrections for NMPA or FDA requirements.
Regulatory Change Alerts
AI monitors NMPA and FDA continuously. Get notified the moment a regulation changes for your specific product category.
Common Questions.
Answers to the questions we hear most often — from brands entering China and Chinese companies expanding internationally.
How long does NMPA medical device registration take in China?
It depends on device class. Class I (lowest risk) takes 3–6 months via filing. Class II typically 12–24 months. Class III (implantables etc.) can take 24–48+ months. A complete, compliant dossier is essential — incomplete submissions are the most common cause of delay and re-submission cycles.
Do I need a Chinese legal entity to register a medical device with NMPA?
No. Foreign manufacturers must appoint a China-based Authorized Agent (授权代理人) — you do not need your own Chinese entity. The agent acts as legal representative for the registration. We help clients identify and coordinate with vetted authorized agents as part of our service.
What is Blue-hat (保健食品) registration — and do I need it?
Blue-hat (蓝帽子) is China's certification for dietary supplements and functional foods making health claims (e.g. immunity, bone health). If your product makes any health function claim, Blue-hat registration is mandatory before sale in China. The process takes 24–36 months for imported products. Products with no health claims may qualify for import under GACC registration as general food instead.
What FDA requirements must Chinese supplement brands meet when entering the US?
Key requirements: (1) Manufacture under cGMP standards (21 CFR Part 111); (2) Submit a New Dietary Ingredient notification if any ingredient was introduced post-1994; (3) Ensure all label claims comply with FDA and FTC guidelines — structure/function claims permitted, disease claims prohibited; (4) Register the manufacturing facility with FDA. Chinese facilities must also meet US FDA inspection standards separately from GACC registration.
How much does NMPA medical device registration cost?
Two cost components: (1) Government fees — Class II ~$29K USD, Class III ~$43K USD, passed through at cost. (2) Consulting fees — strategy and dossier preparation from $4,500; full end-to-end registration execution from $28,000. Total cost varies significantly by device type, existing documentation quality, and whether clinical data is required.
What is GACC registration and when is it required?
GACC (General Administration of Customs of China) registration is mandatory for all overseas manufacturers exporting food, beverages, and supplements to China — required since 2022. It is separate from Blue-hat registration: a product may need both. GACC registration covers the manufacturing facility and typically takes 3–6 months.
Can a foreign company sell health products in China without NMPA registration?
Medical devices cannot — NMPA registration is a legal prerequisite, no exceptions. For supplements, cross-border e-commerce (CBEC) platforms like Tmall Global offer a limited pathway that bypasses full registration, but with strict claim restrictions and limited product scope. This route carries compliance risk and is not appropriate for all products. We advise clients on which pathway is right for their specific product and market goals.
Let's Talk.
Whether you have a specific project in mind or just want to understand your options, we're here.
Reach Our Team Directly
We respond to all enquiries within 1 business day. For project-specific questions, book a free 20-minute discovery call — we'll listen carefully and tell you exactly what you need, and whether we're the right fit.
Send Us a Message
We'll get back to you within 1 business day.
Not Sure Where to Begin?
Book a free 20-minute discovery call. We'll listen, tell you exactly what you need, and be honest about whether we're the right fit.