What is the typical lead time for international bulk procurement orders?

Standard catalog items with available inventory are typically dispatched within 7–14 working days. Custom OEM/ODM manufacturing or large bulk contract orders are completed within 30–45 days depending on exact specification and compliance requirements.

Does CareFix support international distributor authorization and regulatory document registration?

Yes. CareFix provides comprehensive technical dossiers, ISO 13485 certification packages, Certificates of Free Sale (CFS), material test reports, and technical data sheets required for local Ministry of Health registration.

Can CareFix fulfill custom OEM/ODM medical device manufacturing requests?

Yes. Operating from our self-owned facility in Shanghai Songjiang Economic Development Zone with over ¥70M investment, our engineering team handles precision CNC machining, custom surface treatments, cleanroom packaging, and private label OEM/ODM services.

Contact Shanghai CareFix Medical | Orthopedic Implants & Systems Manufacturer

Global Procurement & Support Hub

Connect directly with Orthopedic Device Engineers

Whether you are an international medical device distributor, hospital procurement director, or OEM partner, our specialized export teams offer direct technical consultation and commercial support.

Shanghai CareFix Medical Instrument Co., Ltd.

ISO 13485 Certified Manufacturer | Established 2009 | State-Level Industrial Zone

Manufacturing & R&D Plant Address

No. 31, Lane 1515, Rongle East Road, Songjiang District, Shanghai, 201600, P.R. China

Shanghai Songjiang Economic & Technological Development Zone

Global Hotlines & Direct Messaging

Toll-Free Hotline: +86 400 098 2859

WhatsApp Support: +86 189 1869 2517

Official Business Email Contacts

Global Trade & Sales: [email protected]

Technical & OEM Support: [email protected]

Overseas Business Dept.

International distribution contracts, territory exclusivity, and bulk hospital tender support.

OEM / ODM Technical Dept.

Custom titanium implant machining, drawing review, rapid prototyping, and private labeling.

Regulatory Affairs (RA)

ISO 13485 compliance dossiers, CFS documentation, free sale certificates & MOH registration support.

Logistics & Fulfillment

Worldwide air express, temperature-controlled shipping, customs handling, and stock tracking.

Verified E-E-A-T Quality Assurance

CareFix operates strictly under internationally recognized medical device manufacturing standards to safeguard surgical safety and regulatory compliance.

ISO 13485:2016 Certified full-process Quality System.

16+ Years Experience specializing in orthopedic external & internal fixation.

30+ Invention & Utility Patents in orthopedic instrumentation & ring fixators.

Trusted by 365+ Hospitals across 32+ countries and regions.

¥70 Million Capital Investment in 5-axis DMG MORI CNC equipment & 100,000-class cleanrooms.

Operating & Response Hours

Our dedicated export team operates on extended hours to align with international time zones across North America, Europe, the Middle East, and Latin America.

Monday – Friday: 08:30 – 17:30 (GMT+8)
24/7 Digital Inquiry Support: Instant assistance for urgent hospital emergency orders.

Procurement Guidance

Frequently Asked Questions for International Buyers

Key details regarding minimum order quantities, custom manufacturing capabilities, and registration documentation.

What is the lead time for standard product orders?

Catalog orthopedic implants (e.g., standard Kirschner wires, locking plates, external fixator components) are maintained in safety stock and shipped within 7 business days. Custom configurations or high-volume orders require 30 to 45 days.

Can CareFix provide registration support for local Health Authorities?

Yes. We assist authorized global distributors by preparing comprehensive technical files, ISO 13485 certificates, material biocompatibility test reports, and Free Sale Certificates (CFS) for national health authority registrations.

What materials are utilized in CareFix medical implants?

We exclusively utilize medical-grade Implant-Class Titanium Alloys (TC4 / Ti-6Al-4V ELI) and Stainless Steel (316L) conforming strictly to ASTM F136 and ISO 5832 standards for biological safety and high mechanical strength.

Does CareFix offer OEM / ODM contract manufacturing services?

Yes. We partner with international medical device brands to offer OEM and ODM solutions, including precision CNC machining, custom laser marking, surface anodization, and sterile cleanroom packaging.

Shanghai Manufacturing Facility Location Map

Located 35 minutes from Shanghai Hongqiao International Airport & High-Speed Railway Hub.

Ready to Partner with CareFix Medical?

Connect with our technical sales engineers for competitive factory-direct pricing, product samples, or customized orthopedic manufacturing proposals.

Get a Quote Get a Quote