China Medical Device Group
China Med Device is a US-based regulatory and commercialization consulting firm that serves as a qualified NMPA legal agent, helping overseas medical device, IVD, CDx, and combination product manufacturers navigate China market entry across registration, clinical, and commercialization stages.
- Company typePrivate
- Founded2015
- HeadquartersNorth Andover, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What China Medical Device Group does
China Med Device, LLC, operating under the trade name China Medical Device Group, is a US-based regulatory and commercialization consulting firm headquartered in Cambridge, Massachusetts with offices in Boston, Beijing, and Hainan. The firm specializes in guiding overseas medical device, in vitro diagnostic (IVD), companion diagnostic (CDx), and combination product manufacturers through China market entry, operating as a qualified NMPA legal agent that provides in-country representation so foreign manufacturers can manage the full product lifecycle without establishing a local Chinese entity.
The service portfolio is structured across three integrated practice areas: Regulatory Affairs (RA strategy, NMPA classification, product registration, QMS/PMS, in-country representation, human factors/usability, and specialized pathways for IVD, CDx, SaMD, and cosmetics), CRO services (clinical trial management, overseas clinical data acceptance, clinical evaluation reports, and Real-World Data programs including the Hainan Boao Lecheng pilot), and Commercialization services (market assessments, reimbursement and partnership strategy, hospital and KOL network access, and distribution qualification). The firm also publishes the annual China NMPA Bluebook as a regulatory intelligence resource.
The business operates as a privately-held LLC led by CEO Grace Fu Palma, with a small team (1-10 employees) of bilingual, bicultural professionals. Revenue is generated through project-based professional services engagements sold directly to enterprise clients via consultative B2B sales, with no publicly disclosed pricing or fee structure. Marketing is content-driven, relying on webinars, white papers, newsletters, and industry conference participation to attract foreign medtech manufacturers seeking China market access.
China Medical Device Group firmographics
Firmographics- Name
- China Medical Device Group
- Legal name
- China Med Device, LLC
- Website
- https://chinameddevice.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- China Med Device is a US-based regulatory and commercialization consulting firm that serves as a qualified NMPA legal agent, helping overseas medical device, IVD, CDx, and combination product manufacturers navigate China market entry across registration, clinical, and commercialization stages.
- Ownership category
- akta.pro rank
China Medical Device Group industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Professional, Scientific, and Technical Services (54), Scientific Research and Development Services (5417)
- SIC
- Services-Health Services (8000)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industry
- Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)
Keywords
Where China Medical Device Group is headquartered
LocationHeadquarters
- HQ city
- North Andover
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
China Medical Device Group business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Regulatory Affairs Consulting Services: Provides turnkey regulatory solutions including RA strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS services for medical devices, IVDs, CDx and combination products entering China market.
- CRO Services: Complete China CRO solution including clinical pathway strategy, CER writing, clinical trial implementation, overseas clinical data utilization, and Real World Data (RWD) pathways including Hainan Real-World Data/Study program.
- Commercialization Services: Market assessments, reimbursement strategy, partnership strategy, and distribution qualification services for medtech companies entering China.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels6 records
China Medical Device Group product offering
Product offeringCore offering
China Med Device, LLC (operating as China Medical Device Group) provides regulatory affairs, clinical research organization (CRO), and commercialization consulting services to overseas medical device, IVD, CDx, and combination product manufacturers seeking to enter the China market. The firm serves as a qualified NMPA (China National Medical Products Administration) legal agent with offices in Boston, Beijing, and Hainan, enabling foreign manufacturers to register products, run local clinical trials, and commercialize in China without establishing their own local entity.
Product overview
China Med Device, LLC is a regulatory and commercialization consulting firm that provides turnkey solutions for medical device, IVD, companion diagnostics (CDx), and combination products entering the China market. The company operates as a qualified NMPA legal agent with offices in Boston, Beijing, and Hainan, enabling foreign manufacturers to represent their complete product lifecycle without establishing a local Chinese entity. The service portfolio centers on three integrated practice areas: Regulatory Affairs (RA) services including strategy, NMPA registration, QMS/PMS, classification, human factors/usability, and specialized pathways for IVD, CDx, SaMD, and cosmetics; CRO clinical services encompassing clinical trial management, overseas clinical data acceptance, CER preparation, and Real-World Data/Study programs including the Hainan RWD pilot; and Commercialization services covering market research, reimbursement strategy, partnership development, and distribution qualification. The company also publishes the annual China NMPA Bluebook as a regulatory intelligence resource. The offering is structured as a platform of interconnected consulting and agency services rather than a software product.
Differentiator
Problem solved
Functional benefit
Products and services
- NMPA Registration Services End-to-end China NMPA (formerly CFDA) registration service for foreign medical device, IVD, companion diagnostic, and combination product manufacturers. Includes regulatory strategy, dossier preparation, submission, and qualified legal agent representation in China, allowing overseas manufacturers to register products without establishing a local Chinese entity.
- Clinical Trial CRO Services Contract Research Organization (CRO) services supporting clinical trials required for NMPA registration of medical devices in China. Targets overseas manufacturers needing compliant local clinical evidence to support their China market entry.
- Commercialization Services Post-approval commercialization support for overseas medical device manufacturers in China, including hospital White Paper / Key Opinion Leader development, channel and distribution partner sourcing, and sales strategy execution.
- Quality Management System (QMS) Compliance Quality Management System compliance and consulting aligned with NMPA requirements for overseas medical device manufacturers, supporting GMP compliance and ongoing quality obligations in China.
- Post-Market Surveillance (PMS) Services
Companies that use China Medical Device Group
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles1 record
China Medical Device Group technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
China Medical Device Group partnerships and signals
Strategic signalScale indicators3 records
Recent moves6 records
Expansion highlights5 records
China Medical Device Group competitors and assessment
Company assessmentDirect peers
- Asia Actual: Specialized medical device regulatory and CRO consultancy focused on Asia-Pacific market entry (China, Japan, Korea, Taiwan). Directly competes with China Med Device in the same niche of helping overseas device manufacturers secure Asian regulatory approvals.
- Pacific Bridge Medical: US-based Asia regulatory and commercialization consultancy for medical devices and IVDs, with deep China expertise. Overlaps directly with CMD's regulatory strategy, registration, and clinical services for medtech manufacturers.
- NAMSA: Global medical device-focused CRO offering regulatory, clinical, and laboratory services. NAMSA's medical device specialization and full-lifecycle model closely mirror CMD's RA + CRO service architecture.
- R&Q Solutions: Medical device regulatory and quality consulting firm serving manufacturers globally with RA, quality systems, and clinical strategy. A direct competitor in the medical device regulatory services niche.
Broad incumbents
- Parexel International: Large global CRO offering comprehensive regulatory, clinical, and commercialization services across pharma and medical devices, with established China operations. Represents the incumbent scale player CMD competes against on enterprise accounts.
- IQVIA: Largest global CRO with integrated real-world evidence, regulatory affairs, and commercialization services. China presence and bundled offerings compete with CMD's full-stack value proposition for enterprise medtech.
- ICON plc: Global CRO and clinical research services provider with extensive medical device and Asia-Pacific operations. Provides overlapping regulatory and clinical trial services to medtech manufacturers entering China.
- NSF International (Health Sciences): Global health sciences regulatory, quality, and compliance services organization with medical device expertise. Competes with CMD in regulatory affairs and QMS consulting for medtech manufacturers.
Regional players
- Hangzhou Tigermed: Leading China-based CRO providing clinical research and regulatory services across pharmaceuticals and medical devices. Serves as the dominant domestic counterweight that overseas-focused consultancies like CMD must differentiate against.
- WuXi AppTec: China-headquartered CRO/CDMO with comprehensive preclinical, clinical, and regulatory services for global biopharma and medtech. Represents the largest local competitor with scale, capital, and integrated delivery capabilities.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
China Medical Device Group social profiles
Digital presenceChina Medical Device Group financial estimates
Financial estimateRevenue estimate
Valuation estimate
China Medical Device Group leadership team
Management profileNumber of profiles
Profiles1 record
China Medical Device Group funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
China Medical Device Group M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about China Medical Device Group
What does China Medical Device Group do?
China Med Device, LLC (operating as China Medical Device Group) provides regulatory affairs, clinical research organization (CRO), and commercialization consulting services to overseas medical device, IVD, CDx, and combination product manufacturers seeking to enter the China market. The firm serves as a qualified NMPA (China National Medical Products Administration) legal agent with offices in Boston, Beijing, and Hainan, enabling foreign manufacturers to register products, run local clinical trials, and commercialize in China without establishing their own local entity.
Is China Medical Device Group a public or private company?
China Medical Device Group is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was China Medical Device Group founded?
China Medical Device Group was founded in 2015. It employs 1 to 10 people.
Where is China Medical Device Group based?
China Medical Device Group is headquartered in North Andover, United States, in the North America region.
How does China Medical Device Group make money?
Three revenue lines are on record. Regulatory Affairs Consulting Services are the primary driver. The others are CRO Services and commercialization Services.
Who are China Medical Device Group's main competitors?
Direct peers on record are Asia Actual, Pacific Bridge Medical, NAMSA and R&Q Solutions. Broad incumbents are Parexel International, IQVIA, ICON plc and NSF International (Health Sciences). Regional players are Hangzhou Tigermed and WuXi AppTec.
Does China Medical Device Group have an API?
No public API is recorded for China Medical Device Group.
What industry is China Medical Device Group in?
China Medical Device Group's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of BPADANAJ, Health, Pharmaceuticals & Medical Devices Regulatory Cooperation. Its NAICS code is 54 and its SIC code is 8000.