Every ZHOBAI product is manufactured to meet the regulatory requirements of your destination market. CE, ISO 13485, FDA, and SGS documentation is prepared in parallel with production — ready for customs clearance on arrival.
CE marking confirms our products meet EU health, safety, and environmental protection requirements under the Medical Device Regulation (MDR 2017/745). Required for all medical furniture sold in European Economic Area markets.
ISO 13485 is the international standard for quality management systems specific to medical device manufacturers. It governs our design controls, production processes, traceability, and post-market surveillance — the highest QMS standard for the healthcare sector.
ISO 9001 certification covers our end-to-end quality management system — from incoming material inspection to final product release. It underpins every production process and is the baseline quality standard accepted by procurement authorities worldwide.
Our facility is registered with the U.S. FDA under 21 CFR Part 807. FDA registration is required for medical devices and healthcare furniture sold into U.S. hospitals and clinics, and is increasingly requested by procurement teams in Latin America and Canada.
SGS is the world's leading inspection and certification company. Our pre-shipment inspections are conducted by SGS inspectors at our factory — providing independent, third-party verification of product quality, quantity, and specification compliance before your cargo leaves China.
Individual product categories are tested and certified against relevant EN standards including EN 1335 (office seating), EN 13761 (visitor seating), and EN 527 (work surfaces) — plus custom testing for clinical-specific durability and infection-control surface requirements.
You don't wait for production to finish before paperwork starts. Our compliance team prepares destination-specific documentation as your order moves through production — so your folder is ready before your container is sealed.
We confirm your destination country's regulatory requirements at order confirmation — EU, GCC, U.S., Southeast Asia, or other markets each have specific requirements we map in advance.
CE Declaration, ISO certificates, test reports, FDA registration documentation, and SGS inspection booking are initiated at production start — running in parallel, not after.
SGS or your nominated third-party inspector verifies specification compliance, quantity, and quality at our factory before loading. Inspection reports issued within 48 hours.
A full compliance folder — certificates, test reports, packing lists, bill of lading, and country-specific declarations — is provided digitally and in hard copy with every shipment.
| Product Category | CE | ISO 13485 | ISO 9001 | FDA | SGS (on request) |
|---|---|---|---|---|---|
| Hospital / Care Beds | ✓ | ✓ | ✓ | ✓ | ✓ |
| Medical Trolleys & Carts | ✓ | ✓ | ✓ | ✓ | ✓ |
| Nurse Stations | ✓ | ✓ | ✓ | — | ✓ |
| Patient & IV Chairs | ✓ | ✓ | ✓ | ✓ | ✓ |
| Medical Cabinets & Storage | ✓ | ✓ | ✓ | — | ✓ |
| Waiting Room & Visitor Seating | ✓ | — | ✓ | — | ✓ |
| Wash Basins & Sanitiser Units | ✓ | ✓ | ✓ | — | ✓ |
| Custom OEM / ODM Products | ✓ | ✓ | ✓ | On request | ✓ |
Share your destination country and product requirements. Our compliance team will confirm which certificates apply and send copies within one business day.