Jieke Medical holds multiple international certifications, enabling our products to be distributed and registered in regulated markets worldwide.
CE marking certifies that Jieke Medical products conform to EU health, safety, and environmental protection standards, granting unrestricted access to all EU and EEA markets. Our product technical files are maintained and regularly updated.
Our Quality Management System is certified to ISO 13485:2016 — the international standard specifically designed for medical device manufacturing. This certification covers design, development, production, installation and servicing of medical devices.
Key Jieke Medical product lines are registered with the U.S. FDA as medical devices under 21 CFR Part 807. FDA listing enables legal importation and commercial distribution in the United States and facilitates regulatory acceptance in FDA-harmonized markets.
Our manufacturing facility complies with WHO Good Manufacturing Practice guidelines, which is a prerequisite for supplying to government health programs, UN procurement agencies, and development organization tenders (UNICEF, ICRC, MSF).
ISO 9001:2015 certification validates our systematic approach to quality management across all business functions — from supplier qualification and incoming inspection to production, delivery and after-sales service.
Products registered with China's National Medical Products Administration (NMPA), formerly CFDA, confirming compliance with Chinese medical device regulations and enabling legal manufacturing and domestic market distribution.
Our ISO 13485-certified QMS governs every step of the product lifecycle — from supplier selection to post-market surveillance — ensuring consistent quality and regulatory compliance.
All raw material and component suppliers are evaluated, approved and regularly audited against our supplier quality requirements.
100% inspection of critical components and statistical sampling of raw materials per AQL standards before production entry.
Continuous quality checks at each production stage with real-time non-conformance detection and corrective action protocols.
Full functional testing of every finished product against approved specifications before packing and shipping approval.
Systematic collection and analysis of field performance data to support continuous product improvement and regulatory reporting.
Annual internal and external audits ensure our QMS remains compliant, effective and continuously improving. Last external audit: 2024 — Zero Major Non-Conformities
Every Jieke Medical product goes through a rigorous 4-stage quality-controlled manufacturing process.
Design validation, risk analysis (ISO 14971), and regulatory review before any production begins.
Cleanroom assembly where required, step-by-step IPQC verification and traceability throughout.
Electrical safety (IEC 60601), EMC, performance and aging tests by our in-house laboratory.
Compliant labeling, complete technical documentation, and third-party test reports issued with every order.
Our fully equipped testing laboratory ensures products meet all applicable international standards before they leave our facility.
Comprehensive electrical safety testing per IEC 60601-1 and relevant particular standards for all active medical devices.
Electromagnetic compatibility testing to IEC 60601-1-2 ensuring devices do not interfere with or are affected by other equipment.
Temperature cycling, humidity, vibration and drop tests to verify product reliability under real-world transport and use conditions.
Functional and accuracy testing against product specifications and relevant particular standards for each device category.
Biocompatibility assessment per ISO 10993 for all patient-contact materials — including cytotoxicity and sensitization testing.
Sterility assurance level (SAL 10⁻⁶) testing and package integrity validation for all sterile medical consumables.
Our certifications provide market access across all major regions. We can also assist clients in obtaining local market registration for their specific country.
CE Mark / MDR 2017/745
FDA 510(k) / De Novo
WHO GMP / CE accepted
CE / ISO 13485 accepted
CE / FDA accepted
ANVISA, INVIMA, DIGEMID
NMPA Registered
WHO GMP / Prequalification
We provide full quality documentation packages including CE certificates, ISO 13485 certificate, FDA listing confirmations, test reports, and Declaration of Conformity for all product lines.