Over the past year, concerns about fair access to public tenders for medical devices have intensified.

The European Commission launched the first investigation under EU International Procurement Instrument (IPI) to assess China’s public procurement landscape.

The investigation took 9 months. It focused on whether EU-based manufacturers are placed at a competitive disadvantage in China’s hospital tenders.

One of the findings indicates that the Chinese Policy heavily promotes the domestic medical devices industry.

This doesn’t sound bad, right? It is understandable why the country encourages domestic growth.

The prominent example is the ‘Made in China 2025’ Strategy.

The initiative specifies that the local hospital shall procure high-end medical devices domestically. The local procurement should reach 50% by 2020, 70% by 2025 and 95% by 2030.

But, foreign companies will have a harder time competing in China. This adds to the existing complex regulatory regime.

It has a HUGE impact.

Global public procurement is worth over €11 trillion per year! This is a golden business opportunity for medtech manufacturers.

There has been dialogue between Brussels and Beijing. But it didn’t seem to go so well…

On June 20th, the European Commission published a press release to restrict the participation of Chinese companies in the EU’s medical device procurement.

This escalates the situation.

🍜 EU-China Trade Relationship At Risk

The Chinese Ministry of Commerce (MOFCOM) has issued a notice to limit the participation of EU-imported medical devices in Chinese public procurement activities.

The restrictions apply to procurements that (i) involve imported medical devices and (ii) exceed RMB 45 million (≈ €5 million) in contract value.

This is equivalent to the restrictions imposed by the European Commission.

In such cases, EU companies must be excluded from the bidding. But, European-funded entities established in China are not affected.

50 types of medical devices, in-vitro diagnostics, and veterinary products (see grouped list below) will be affected by the notice.

🍜Implications for Others

Non-EU bidders must now limit the value of EU-origin devices at 50% of the total contract when participating in Chinese public tenders.

MOFCOM has included a narrow “clinical-necessity” exemption due to the possible shortage of supply of certain medical devices.

The notice does not apply when EU-manufactured devices are the only source that meets the tender’s requirements.

This prevents China from shooting itself in the foot.

The policy took effect on 6 July 2025, just three days after its release.

The EU-China trade relationship is under intense pressure, as retaliatory restrictions are now in force on both sides.

There will be less price pressure on suppliers in the EU. But hospitals lose a low-cost source for consumables.

Hospitals may soon face supply gaps in affected medical devices. It puts patients at risk of delayed or reduced access to medical treatment.

🍜How Can Foreign Manufacturers Respond?

Localization is the best way to safeguard the Chinese market share. Having a presence in a country does make a difference.

There are two ways to do so:

Transfer an existing approval of an imported medical device to a China-based site

• This may work if you already hold Chinese registration for a device and have a suitable site in China.

• This pathway has been introduced to encourage foreign manufacturers to take part in “Made-In-China 2025”.

• Check out my previous newsletter to evaluate whether you are eligible.

Build or partner for local production

• This option applies if you do not have any existing registration.

• Establish your own facility compliant with China’s GMP and Quality Management System requirements.

• Or engage a Contract Development and Manufacturing Organization already licensed in China as an alternative.

This will strengthen your chances of winning tenders and expand your reach to local customers across China.

Need a second opinion on the best path forward? Book a complimentary strategy call here.

 🍜 List of Affected Products

Radiotherapy and Medical Imaging Devices

• Medical radiation therapy equipment

• Medical X-ray monitoring equipment and tools

• MRI equipment and accessories

• X-ray diagnostic equipment and accessories

• Medical optical instruments

• Medical ultrasonic instruments and equipment

• Medical endoscopes

• Nuclear medicine diagnostic equipment and assisted accessories

Medical diagnostic and monitoring devices

• General examination instruments (e.g. thermometer, stethoscope, etc)

• Medical electronic physiological-parameter monitors

• Medical radiation monitoring equipment and tools

• Psychological instruments (for medical use)

Surgical Devices

• Medical laser instruments and equipment

• Operating-room equipment and accessories

• Surgical instruments

Physiotherapy Devices

• Equipment for physiotherapy/ rehabilitation/ sports therapy

• Medical cryogenic and cold therapy equipment

Implantable Devices

• Artificial organs and functional assistive devices

• Interventional/implantable diagnostic and therapeutic devices

• Orthopaedic implants

Nursing and Protection Equipment

• Medical radiation protection equipment

• Epidemic-prevention/ protective hygiene equipment and tools

• General and medical rubber products (for medical use)

• Medical uniforms

Medical Rehabilitation Devices

• Prosthetic devices and components

• Assistive devices for disabled persons

Other Medical Devices

• Emergency and life-support equipment (defibrillators, ventilators, etc.)

• Dental equipment and instruments

• Extracorporeal circulation equipment

• Disinfection and sterilization equipment and instruments

• Clinical laboratory equipment

• Medical device components

• Pharmacy equipment and tools

• Ward-care and general hospital equipment (beds, stretchers, wheelchairs)

• Other IVD and veterinary products

🍜 Bonus Reading

• Notice of the China’s Ministry of Commerce on taking measures on medical devices imported from the EU in government procurement.

• The role of EU International Procurement Instrument (IPI) Regulation in controlling the EU public procurement procedures.

• How EU Regulation ensures the access of third-country economic operators, goods and services to the Union’s public procurement according to (EU) 2022/1031.

• MD+DI shared great insight on the emerging EU–China procurement tensions.

Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.