Foundational Collaboration
Core Focus Areas of Greatest Concern to Clients
Our factory does not produce its own brand; we focus exclusively on R&D and manufacturing. We have an R&D team composed of PhDs, as well as Class 10,000 GMP cleanrooms and laboratories. We provide contract manufacturing and private labeling services exclusively to brand owners, distributors, and medical institutions. We sign formal cooperation agreements and never compete with our clients for market share, ensuring the exclusivity of their distribution channels.
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Our factory holds all necessary certifications and can provide a complete set of compliance documents. Core certifications include: Medical Device Manufacturing License, Class II Medical Device Registration Certificate, ISO 13485 Medical Quality Management System Certification, and FDA Certification (for the U.S. market). We can provide original documents for verification and retain copies, fully meeting the requirements for domestic sales and export contract manufacturing.
3. What is your factory’s core production capacity? Can you meet the demands of large-volume orders?
Our facility features a 6,000-square-meter GMP cleanroom production workshop compliant with Class 100,000 standards, a 1,000-square-meter laboratory compliant with Class 10,000 standards, and automated production lines. We specialize in the production of kaolin hemostatic gauze, with a daily production capacity of 50,000 pieces and a monthly capacity of 1.5 million pieces. We can handle small-batch trial orders (scalable to mass production after prototyping) as well as large-volume orders. During peak seasons, we can flexibly adjust production capacity to ensure stable delivery schedules.
OEM & ODM Service
Our Key Service Details
We offer full-service private label manufacturing with a simple and efficient process:
- The client provides the brand logo, packaging design, and relevant authorization documents;
- Our factory reviews the design for compliance (ensuring it meets medical product packaging standards);
- Sample approval (production of packaging bags);
- Signing of the private label agreement and non-disclosure agreement; 5. Mass production, printing of the private label, quality inspection, and bagging.
We offer comprehensive customization to meet client needs:
• Product Customization: Gauze dimensions, thickness, kaolin coating content, hemostatic performance parameters, sterilization method (ethylene oxide/irradiation);
• Packaging Customization: Packaging box material, dimensions, printed graphics (logo, product description, certification marks), individual packaging style, and carton specifications;
• Additional Customization: Customized instruction manuals (multilingual versions for domestic and international markets), and printing of product traceability codes.
Three core documents are required: 1. The brand owner’s business license and Medical Device Operating License (if the client is a distributor); 2. Brand logo authorization documents and packaging design drafts; 3. For exports, relevant compliance documents for the target market (e.g., U.S. FDA registration documents, EU CE Declaration of Conformity). All customization must comply with the Regulations on the Supervision and Administration of Medical Devices; our factory will assist with review to avoid compliance risks.
Collaboration Processes & Details
Reducing Communication Costs for Clients
Complete process: Initial consultation → Sample provision → Customer sample approval → Signing of cooperation contract + payment of deposit (50%) → Custom prototyping (several days) → Mass production → Quality inspection → Payment of balance → Shipment; The total lead time is estimated at 7–20 days depending on order volume, with expedited service available for small-batch orders.
To accommodate customer trial order needs, the MOQ is flexible: the standard MOQ is 10,000 pieces, while the minimum for small-batch trial orders is 1,000 pieces. Trial order prices differ slightly from bulk order prices; upon successful trial, subsequent bulk orders will qualify for corresponding discounts.
Samples are provided for a fee, which will be refunded upon formal order placement. Our kaolin hemostatic gauze is a finished product developed through extensive testing by our professional R&D team; we do not recommend modifying specifications or parameters on your own. For special customization (e.g., custom sizes, specific coating content), the sample lead time will vary depending on the situation.
Standard payment terms: A 50% deposit is required upon signing the contract. After production is complete, quality inspection is passed, and the customer confirms the goods are in good order, the remaining balance is paid, and our factory ships the goods immediately.
Quality & After-sales Service
Addressing Customer Concerns About Collaboration
Our factory has established a comprehensive quality control system covering the entire production process. From raw material procurement (kaolin, medical gauze) to manufacturing, sterilization, and final product inspection, every step is documented and traceable. Before finished products are shipped, we conduct random sampling tests (hemostatic efficacy, sterility, and appearance) to ensure compliance with national medical device standards. If quality issues arise that are not caused by improper storage or transportation by the customer, our factory will unconditionally accept returns or exchanges and cover the corresponding shipping costs. We will also optimize our production processes to prevent similar issues from recurring.
We provide a product quality inspection report (bearing our official seal) for every batch of orders. If the customer requires third-party testing, we can provide samples and assist in coordinating with third-party testing agencies (such as SGS or Puni Testing). Testing fees are the customer’s responsibility, and any products that fail testing will be handled in accordance with our after-sales policy.
Export & Confidentiality
For International Distributors
We support global exports and can provide the full set of compliance documents required for export, including: commercial invoices, packing lists, bills of lading, product quality inspection reports, FDA/CE certification documents, ISO 13485 certification documents, medical device registration certificates (translated copies), and certificates of origin. We can also coordinate with professional medical freight forwarders to handle cold chain transportation and customs registration, ensuring smooth customs clearance for the products.
We will maintain strict confidentiality. A formal Non-Disclosure Agreement (NDA) will be signed at the start of the partnership, explicitly stipulating that our factory shall not disclose the client’s brand information, packaging design, order quantities, customization parameters, pricing, or other core information; nor shall we use the client’s customized products or packaging designs for other clients or our own promotional purposes;
Other Frequently Asked Questions
On-site tours are available. Customers must contact us at least 3 days in advance, and we will arrange for a dedicated representative to host the tour and answer any questions on-site.
We provide nationwide and global logistics and delivery services: For domestic shipments, we use logistics providers such as SF Express, ZTO Express, and Deppon Express, with standard orders delivered within 2–4 days; For details regarding exports and customs clearance, please contact us for further discussion.
Long-term partners are eligible for three major benefits: 1. Volume discounts (the larger the order, the lower the unit price); 2. Priority scheduling and expedited production to ensure on-time delivery; 3. Free consultation on packaging design optimization and product upgrade solutions to help enhance your product’s competitiveness.
