Whether you want to private-label existing products or develop entirely custom medical devices, Jieke Medical has the engineering team, manufacturing capacity, and regulatory know-how to make it happen — efficiently and affordably.
From government health ministries building local brand identity, to international distributors wanting exclusive product lines, to startups entering the medical market — we have served them all with the same commitment to quality and transparency.
Your logo, brand name and colors on ready-made products
Fully engineered to your specifications from scratch
CE, FDA, WHO, NMPA — we handle the paperwork
Trial orders from 50 units to government tenders of millions
Sea, air, express — with full export documentation
Choose the level of customization that matches your business goals — from simple private labeling to full custom device development.
Apply your brand identity to our existing, certified product range. Fastest path to market with lowest investment and full regulatory coverage already in place.
Customize existing platforms with your specific requirements — unique colors, modified features, different display interfaces or specific accessories bundles.
Complete product development from concept to certified device — for clients with specific performance requirements, unique form factors, or new market niches.
A structured, transparent process from initial inquiry to final delivery — managed by our dedicated OEM project team led by Mr. Jacob XU.
Contact Mr. Jacob XU with your requirements — product type, target markets, certifications needed, annual volume forecast, and timeline. We'll schedule a call or video meeting to discuss your project in detail and assess feasibility.
We prepare a detailed project proposal including: recommended product platform or development approach, pricing at different MOQ tiers, regulatory strategy, timeline and payment terms. No hidden costs.
We produce pre-production samples with your branding applied. You review and approve the samples, packaging, documentation and labeling. Any revisions are incorporated before mass production approval.
Our regulatory affairs team prepares the technical file, Declaration of Conformity, and all documentation required for registration in your target markets — CE, FDA, local ministry approvals — running in parallel with production prep.
Quality-controlled production run under ISO 13485 QMS with full traceability. In-process inspection reports shared at agreed milestones. We accommodate third-party pre-shipment inspection if required.
We manage export documentation (packing list, commercial invoice, COO, health certificate), arrange freight and provide tracking. Post-delivery, our technical team supports warranty claims, spare parts and operator training.
Our OEM/ODM program serves a diverse range of clients across the global healthcare value chain.
Build proprietary product lines that differentiate you from competitors, increase margins and create customer loyalty — without running a factory.
National health programs seeking branded, locally-labeled equipment at government tender volumes — with full WHO and regulatory compliance.
Bring your medical device concept to market with an experienced manufacturing partner handling the technical complexity while you focus on sales and go-to-market strategy.
Large hospital networks and healthcare groups procuring standardized, branded equipment for multi-facility deployment at volume pricing.
International medical equipment trading companies seeking reliable China manufacturing partners with proven quality systems and export experience.
Humanitarian organizations sourcing WHO-compliant medical equipment for emergency response, development programs and field hospitals.
Medical device registration is one of the biggest barriers for new market entrants. Our experienced regulatory affairs team guides you through the process for your target markets.
Technical file compilation, notified body liaison, Declaration of Conformity. Applicable to all EU + EEA countries.
Predicate device analysis, substantial equivalence documentation, and FDA establishment registration support.
NAFDAC (Nigeria), TMDA (Tanzania), PPB (Kenya), and other African regulatory authority submissions based on CE/WHO dossiers.
GCC countries, ASEAN markets, India CDSCO — we provide dossier preparation and can coordinate with local registration agents.
When you partner with Jieke Medical for OEM/ODM, regulatory support is not an add-on — it's built into our service. Here's what we provide as standard:
Our pricing scales with your volume — the more you order, the better your unit cost. Contact us for an exact quotation for your product and quantity.
Contact Mr. Jacob XU today to discuss your OEM/ODM project. We'll respond within 24 hours with a tailored proposal for your specific requirements.