Warranty Coverage
Provide standard-setting warranty and flexible extension plans to safeguard hospital assets.
Expert Maintenance
Deliver expert calibration and preventive maintenance to empower healthcare services.
Genuine Spare Parts
Supply genuine parts with strict quality testing to ensure perfect compatibility.
Global Service Excellence
Setting the Standard in Surgical Support
We’re more than a manufacturer—we’re your reliable partner in the OR, ensuring device precision, seamless delivery, and uninterrupted clinical performance.
Quality Management & Regulatory Compliance
Operating under strict global medical device regulatory frameworks, Xishan Technology delivers fully certified surgical solutions, empowering our international distribution partners with comprehensive regulatory dossier support for rapid local market access.
Q1: Which international quality systems and regulatory certificates do Xishan products hold?
Xishan strictly complies with global medical regulatory standards. We hold ISO 13485, ISO 9001, MDSAP, and GMP quality management certifications. Our core surgical power systems and single-use sterile consumables are certified with CE marks (EU MDR), and we hold 6 National Class III and over 40 Class II medical device registrations in China.
Q2: Can Xishan assist local distributors with localized Ministry of Health (MOH) registration?
Yes. Our specialized Regulatory Affairs (RA) team provides end-to-end documentation support, including Free Sales Certificates (FSC/CFS), Certificates of Origin (CO), notarized/apostilled dossiers, technical files, and type-testing reports tailored to your regional MOH import requirements.
Q3: What is Xishan's role in surgical device industry standards?
Recognized as a National Intellectual Property Model Enterprise with over 1,300 approved patents, Xishan is the primary drafting organization of China’s National Industry Standard for Electric Bone Tissue Surgical Equipment (YY/T 0752-2016) and has led or participated in drafting 8 national and industry medical device standards.
Technical Support & Operating Room Assurance
Patient safety and surgical continuity are our highest priorities. We provide rapid technical response, structured warranty coverage, and an emergency standby unit policy to minimize downtime and ensure seamless OR workflow.
Q1: What international clinical training centers has Xishan established?
Xishan has established 7 international clinical training centers, including specialized facilities in Russia (Moscow and St. Petersburg), Brazil (IRCAD ENT Training Center and Neurosurgery Mobile Program), and Uzbekistan, alongside ongoing clinical collaboration with leading Class-A tertiary hospitals across China.
Q2: What surgical simulation and wet-lab facilities does Xishan offer?
Xishan’s 25,800 m² industrial base is equipped with a standardized large-animal laboratory featuring surgical anesthesia machines, ventilators, operating tables, and full 4K endoscopy suites, supporting live-tissue surgical training, procedural demonstrations, and hands-on masterclasses.
Q3: What official partnerships does Xishan maintain with global medical societies?
Shipping, Global Delivery & Traceability
Q1: Which shipping methods and Incoterms do you primarily support?
Q2: What is the procedure if a shipment arrives with damaged packaging?
Q3: How does Xishan guarantee end-to-end product quality traceability?
Global Distribution & Partnership Support
Q1: How can our company apply to become an authorized Xishan distributor?
You can submit an inquiry via our Contact Us form or email us directly at sales@xishanmed.com. Our dedicated regional business development manager will contact you within 24 hours to review market qualifications and tailor a partnership proposal.
