An Employer of Record can help an EU MedTech company employ regulatory, commercial, technical, and customer-support personnel in China without first establishing its own local employing entity.
It cannot, by itself, make the overseas company eligible for a Chinese public tender.
An EOR also does not:
- Register a medical device automatically
- Convert an imported product into a domestically produced product
- Become the manufacturer’s Chinese subsidiary
- Give the overseas company a medical-device distribution license
- Authorize local invoicing or importation
- Satisfy every bidder qualification
- Remove country-of-origin restrictions
- Guarantee that a tender will be awarded
EOR should therefore be treated as one part of a broader China market-entry and procurement strategy.
What changed for EU medical-device procurement?
In June 2025, the European Union adopted an International Procurement Instrument measure affecting access by Chinese companies and Chinese-origin medical devices to certain EU public procurement procedures.
The European Commission’s official medical-device procurement summary explains that the measure applies to relevant EU medical-device tenders valued at €5 million or more.
China subsequently introduced reciprocal measures concerning certain government procurement projects involving EU medical devices.
According to the Chinese Ministry of Finance’s official policy explanation, the measures apply to covered medical-device government procurement projects with a budget of RMB 45 million or more.
The Ministry’s explanation states that, for those covered projects:
- EU enterprises are generally excluded after the applicable procedures, except qualifying EU-invested enterprises established in China.
- Where a non-EU supplier provides EU-imported medical devices, those devices generally cannot exceed 50% of the relevant contract value.
- Origin is determined using the country of origin shown in import customs documentation.
- EU-invested enterprises registered in China can participate, but EU-imported products included in their bids remain subject to the relevant 50% limit.
- Medical devices produced in China by an appropriately established EU-invested enterprise are not treated as restricted EU-imported devices under the measure.
- An exception may apply when only EU-imported medical devices can meet the procurement need and the required justification procedure is completed.
- The measure does not apply automatically to state-owned enterprise purchasing because such purchasing is not necessarily classified as government procurement under the notice.
The exact tender, product category, procurement authority, project budget, bidder identity, and product origin must still be reviewed. Procurement rules and tender documents can also change, so companies should verify the position at the time of each bid.
Why an EOR does not create tender eligibility
An EOR’s Chinese entity employs personnel. It does not become the MedTech company’s corporate subsidiary merely because those employees support the overseas business.
The following parties may all be different:
- Overseas manufacturer
- Medical-device registrant
- Chinese regulatory agent
- Importer
- Distributor
- Tender bidder
- Contracting supplier
- After-sales service provider
- EOR employing entity
- Client company managing the team
Each role carries different responsibilities.
For example, an EOR may employ a regulatory-affairs specialist who coordinates registration documents. That does not make the EOR the medical-device registrant, authorized distributor, importer, or tender bidder.
Likewise, hiring a sales employee through an EOR does not convert EU-made equipment into a Chinese-origin product.
What an EOR can do for a MedTech company
An EOR can help build the local team needed to research, prepare, and support a China market-entry strategy.
Suitable roles may include:
- Regulatory-affairs specialists
- Market-access managers
- Tender-intelligence analysts
- Key-account support personnel
- Clinical application specialists
- Technical-support coordinators
- Distributor-management personnel
- Quality and post-market support staff
- Supply-chain coordinators
- Finance or administrative employees
The scope of each role should be reviewed carefully. Employees should not be given authority to conduct activities that require a separate corporate, distribution, manufacturing, or medical-device license.
An EOR can normally support the employment layer by:
- Providing a local employing entity
- Issuing compliant labor contracts
- Processing payroll
- Withholding individual income tax
- Administering social insurance and housing fund
- Managing statutory leave
- Maintaining HR records
- Supporting onboarding and offboarding
- Coordinating work permits for eligible foreign employees
- Assisting with employment changes and disputes
Read our China Employer of Record guide for a detailed explanation of the employment model.
What an EOR cannot replace
A Chinese bidding or contracting entity
Many tenders require the bidder to meet specific legal, financial, licensing, experience, and product-authorization conditions.
An EOR arrangement does not give the overseas company a Chinese business license or make the EOR’s entity available as the bidder.
The parties must identify who will:
- Submit the bid
- Provide bid security
- Sign the supply contract
- Issue invoices
- Import or supply the equipment
- Receive payment
- Provide warranties
- Maintain the equipment
- Respond to product complaints
- Accept procurement liability
These responsibilities commonly rest with a qualified local subsidiary, distributor, or other authorized supplier—not the EOR.
Medical-device registration
Medical devices must follow China’s applicable filing or registration pathway before being marketed.
Under the National Medical Products Administration’s Provisions for Medical Device Registration and Filing:
- Class I devices are generally subject to filing.
- Class II and Class III devices are generally subject to registration.
- Imported Class I devices are filed with the NMPA.
- Imported Class II and Class III devices are reviewed by the NMPA.
- An overseas applicant or filing entity must designate a Chinese enterprise legal person to act as its agent.
- Registration materials must meet Chinese requirements.
- The applicant remains responsible for product safety, effectiveness, quality, and supporting information.
The domestic regulatory agent is not automatically the same party as the EOR, importer, distributor, or bidder.
Importation and distribution
Medical-device importation and distribution can require appropriate qualifications, product documentation, customs processes, quality controls, and storage or transportation capabilities.
An EOR does not automatically provide:
- Importer-of-record capability
- Medical-device distribution permission
- Warehousing
- Customs clearance
- Cold-chain management
- Product traceability
- Local invoicing
- Warranty infrastructure
Those activities require separate operational and regulatory planning.
Domestic production status
Employing local sales or regulatory personnel does not make a medical device domestically manufactured.
If a company is considering manufacturing in China, it must separately evaluate:
- Establishing or using an appropriate Chinese entity
- Product-registration changes
- Manufacturing licensing
- Quality-management systems
- Manufacturing-site requirements
- Contract manufacturing
- Technology transfer
- Intellectual property
- Supplier qualification
- Product-origin rules
NMPA requirements should be reviewed before assuming that a localized production arrangement will change procurement treatment.
Practical market-entry structures
1. Overseas manufacturer with a Chinese agent and distributor
An EU manufacturer may keep production outside China while appointing the necessary Chinese regulatory agent and commercial distributor.
The distributor may handle importing, sales, invoicing, delivery, or tender participation where appropriately qualified.
An EOR can employ a small local team to support the manufacturer’s:
- Distributor relationship
- Market research
- Product training
- Regulatory coordination
- Technical communication
- Customer feedback
The company must still assess how the 2025 procurement measures affect EU enterprises and EU-origin products in each covered tender.
2. EU-invested Chinese subsidiary
A longer-term strategy may involve forming a subsidiary in China.
The subsidiary may eventually support:
- Direct employment
- Local contracting
- Invoicing
- Distribution activities
- Regulatory responsibilities
- Tender participation
- Local manufacturing
The entity still needs the appropriate business scope, licenses, capital, personnel, systems, and regulatory approvals. Entity formation alone does not make every activity permissible.
An EOR may support employees before the entity is ready, followed by a planned transfer to the subsidiary.
3. Local manufacturing
Domestic manufacturing may affect product origin and procurement treatment, but it involves much more than hiring employees.
The company must evaluate registration, manufacturing approvals, facilities, quality systems, technology, suppliers, and post-market obligations.
An EOR cannot create domestic product status.
4. Distributor-led market entry
For some companies, a qualified distributor may remain the most practical bidder and contracting supplier.
The manufacturer should review:
- Territorial rights
- Tender authority
- Pricing control
- Product-registration ownership
- Customer and tender data
- Minimum purchase obligations
- Sub-distributors
- Anti-bribery controls
- After-sales responsibilities
- Termination rights
- Transfer of registrations and customer relationships
A local EOR team can help oversee the distributor, but it does not replace distributor due diligence.
Roles an EOR team can perform safely
The employee’s authority should be documented before hiring.
Regulatory support
A locally employed regulatory specialist may:
- Coordinate Chinese documentation
- Communicate with an appointed regulatory agent
- Track registration milestones
- Maintain submission records
- Support post-market processes
- Monitor regulatory changes
The employee should not be described as the official regulatory agent unless the relevant legal entity has formally assumed that role.
Tender intelligence
A tender specialist may:
- Monitor procurement notices
- Summarize eligibility requirements
- Maintain a tender calendar
- Coordinate documents
- Track questions and deadlines
- Support the authorized bidder
- Maintain internal approval records
The employee should not submit bids or bind the overseas company unless the authority and legal structure have been reviewed.
Distributor management
A local employee may:
- Monitor distributor performance
- Coordinate training
- Review forecasts
- Collect market feedback
- Escalate compliance concerns
- Support channel communication
Contracts and commercial authority should remain aligned with the approved operating structure.
Clinical and technical support
Clinical application and technical employees may train users or coordinate product support, subject to product rules, hospital requirements, professional qualifications, and the approved scope of the device.
Their responsibilities should not expand informally into regulated services.
Public-tender readiness checklist
Before pursuing a tender, confirm:
Bidder
- Who is legally submitting the bid?
- Is the bidder eligible under the tender documents?
- Does it hold the required licenses?
- Does it meet financial and experience requirements?
- Can it issue compliant invoices?
- Can it provide bid and performance security?
Product
- Is the device properly registered or filed in China?
- Who holds or supports the registration?
- What is the product’s documented country of origin?
- Does the tender require domestic production?
- Are technical specifications and certificates current?
- Are labeling and instructions compliant?
Procurement restrictions
- Is the procurement covered by government procurement rules?
- Is the project budget at or above RMB 45 million?
- Is the bidder an EU enterprise, an EU-invested Chinese enterprise, or another entity?
- What percentage of the proposed contract consists of EU-imported devices?
- Does an exception apply?
- Has the purchaser completed any required import-product review?
- Are special national, provincial, hospital, or centralized procurement rules relevant?
Delivery and after-sales service
- Who imports and delivers the equipment?
- Who installs and commissions it?
- Who provides training?
- Who holds spare parts?
- Who handles maintenance?
- Who reports adverse events?
- Who manages recalls and complaints?
- Who accepts warranty liability?
Employment
- Who employs the local team?
- Are job duties and authority documented?
- Are payroll and statutory benefits administered locally?
- Are working hours and travel controlled?
- Are confidentiality and intellectual property protected?
- Are employee interactions with hospitals and officials governed by compliance policies?
Anti-bribery and tender-integrity controls
Public healthcare procurement creates heightened corruption and conflict-of-interest risks.
EU MedTech companies should establish controls covering:
- Gifts and hospitality
- Hospital sponsorships
- Clinical education
- Conference support
- Distributor commissions
- Tender consultants
- Success fees
- Charitable donations
- Travel expenses
- Interactions with healthcare professionals
- Government and state-owned institution contacts
- Documentation and approval requirements
The company should conduct due diligence on distributors, tender agents, consultants, and other intermediaries.
An EOR can administer employment policies, but the client must design and enforce an appropriate commercial compliance program.
A phased market-entry plan
Phase 1: Feasibility
- Classify the medical device
- Assess the NMPA pathway
- Review procurement restrictions
- Identify the likely bidder and distributor
- Map importation and after-sales responsibilities
- Define the local roles required
Phase 2: Local team
- Select the employment structure
- Hire regulatory and market-access personnel
- Establish payroll and benefits
- Limit employee authority appropriately
- Implement confidentiality and compliance policies
Phase 3: Regulatory and commercial setup
- Complete registration or filing work
- Appoint and review the domestic agent
- Qualify distributors
- Build tender-monitoring processes
- Establish quality and post-market procedures
Phase 4: Tender readiness
- Review the individual tender
- Confirm bidder eligibility
- Verify product origin and restrictions
- Prepare technical and commercial documents
- Complete legal and compliance approval
- Confirm delivery and warranty capacity
Phase 5: Long-term structure
If tender volume, headcount, local revenue, or manufacturing plans increase, consider whether the company needs its own Chinese entity.
The EOR team may then be transferred through an appropriately planned employment process.
Frequently asked questions
Can an EOR help an EU MedTech company win a Chinese public tender?
An EOR can employ the team that supports market research, registration coordination, distributor management, technical work, and tender preparation. It cannot guarantee a win or make an otherwise ineligible overseas company a qualified bidder.
Does an EOR make an EU company a local Chinese enterprise?
No. The EOR is the employee’s legal employer. It does not become the EU company’s subsidiary, manufacturer, distributor, or bidding entity.
Does hiring Chinese employees change the origin of an EU medical device?
No. Product origin depends on the applicable origin rules and manufacturing facts, not the nationality or location of the sales team.
Can an EU-invested company established in China participate?
China’s Ministry of Finance guidance states that qualifying EU-invested enterprises established under Chinese law can participate in covered projects. However, EU-imported devices included in their bids remain subject to the applicable imported-product limit. Each tender and corporate structure must be reviewed separately.
Can an EOR act as the medical-device regulatory agent?
Only if the relevant entity separately satisfies the applicable requirements and formally accepts that role. EOR employment services do not automatically include medical-device regulatory representation.
Final takeaway
An EOR can give an EU MedTech company a practical way to employ a local China team before establishing its own entity.
That can improve market intelligence, regulatory coordination, distributor oversight, technical support, and tender preparation.
It does not bypass public procurement restrictions. Nor does it replace medical-device registration, a qualified bidder, a distributor, importing capability, local manufacturing, or required licenses.
Companies should design the regulatory, procurement, commercial, and employment structures together before making local hires.
Learn more about HROne’s China Employer of Record service or contact HROne to discuss the employment requirements for a China-based MedTech team.
This article provides general information and does not constitute procurement, regulatory, legal, tax, medical-device, or employment advice. Rules and tender conditions can change, so obtain case-specific advice before bidding or entering the Chinese market.
