Regulatory-compliant sourcing from China's ISO 13485-certified medical device manufacturers. Rigorous documentation, third-party testing, and verified supply chains.
China has become a dominant force in global medical device and PPE manufacturing — with Guangdong, Shandong, and Zhejiang provinces hosting hundreds of ISO 13485-certified facilities supplying hospitals, distributors, and government health agencies worldwide.
Our medical sourcing team includes former hospital procurement specialists and regulatory affairs consultants who understand the strict documentation requirements for medical device imports into the EU, US, UK, and GCC markets.
We work exclusively with factories holding the appropriate ISO 13485 certification, CE/MDR approval, or FDA registration relevant to their product category — and we verify these certificates directly with issuing bodies before placing orders.
From basic consumables to complex diagnostic equipment — our medical sourcing desk handles compliant procurement for hospitals, distributors, and NGOs.
ISO 13485 certificates, CE/MDR declarations of conformity, FDA registration numbers, test reports, and product technical files — all verified and assembled for your import process.
We coordinate independent testing at SGS, TÜV, Intertek, or Bureau Veritas — filtration efficiency, biocompatibility (ISO 10993), sterility, and shelf-life testing as required.
Full ISO 13485 QMS audit of production facilities — reviewing batch records, sterilization validation, change control, and CAPA systems before we place a single order.
Temperature-controlled logistics for biologics and diagnostic reagents — and sterile packaging integrity validation for disposable medical devices.
Factory non-disclosure agreements, device master file protection, and supply exclusivity arrangements for OEM medical device programs.
Simultaneous compliance management for EU (MDR 2017/745), US FDA, UK MHRA, and Gulf Health Council — for distributors operating across multiple regulated markets.
Medical products have the highest compliance bar of any product category — we manage every certificate, test report, and declaration required for legal importation.
The international quality management standard specific to medical devices — mandatory for factories supplying regulated markets globally.
EU Medical Device Regulation 2017/745 — replacing the old MDD, with stricter clinical evidence, UDI, and post-market surveillance requirements.
US FDA pre-market notification — required for Class II medical devices sold in the United States. We verify factory FDA establishment registration.
Biological evaluation of medical devices — biocompatibility testing standard covering cytotoxicity, sensitization, and systemic toxicity assessments.
A 12-hospital group in Germany required urgent PPE procurement during a period of peak demand — 2 million surgical masks, 500,000 KN95s, 300,000 medical gowns, and 1 million nitrile gloves — all requiring CE MDR documentation and EN 14683 / EN 149 test reports.
MHT identified 4 qualified factories within 48 hours, coordinated parallel production to meet the 6-week delivery window, arranged independent filtration efficiency testing at a German-accredited lab, and delivered all goods with complete regulatory documentation accepted by the hospital group's compliance team.
Get a Similar QuoteFactory identification and qualification for specific medical device and PPE categories.
Batch record review, sterility checks, and performance testing coordination for medical products.
Express air freight and cold chain logistics for urgent or temperature-sensitive medical shipments.
Share your product requirements and target market. We'll identify qualified, certified factories and prepare a full compliance documentation checklist for you.
Real footage from Yiwu market, our factory network, and sourcing operations. No stock videos.
The sourcing hub where MHT Trading operates — 75,000+ suppliers under one roof.
Factory negotiation, QC, shipping — why top buyers trust a boots-on-ground China agent.