CDMO & Cross-Border Contract Manufacturing in China
CDMO (Contract Development and Manufacturing Organization) partnerships let international medical device companies manufacture in China using pre-qualified facilities — without the capital burden of building their own factory.
How CDMO Works
MTL facilitates cross-border contract manufacturing for international medical device companies through a four-step process:
Partner Selection
MTL identifies suitable Chinese CDMO partners based on your product specifications, manufacturing capacity, certifications, and compliance history.
Contractual Arrangement
We negotiate and establish manufacturing agreements compliant with Chinese law, IP protection, and quality standards.
NMPA License Application
MTL guides the application for China manufacturing licenses and supports regulatory documentation throughout the process — see also NMPA Registration & Licensing.
Quality Oversight
Ongoing production monitoring, process validation, and regulatory compliance verification.
Why Manufacturers Choose CDMO in China
The core advantage of the CDMO model is speed and reduced capital exposure: manufacturers reach the Chinese market in an estimated 6–12 months, compared with 18–24 months for building a new facility, while gaining access to pre-certified manufacturers and maintaining full regulatory compliance throughout.
Frequently Asked Questions
What is CDMO facilitation, and how can MTL help international companies?
CDMO (Contract Development and Manufacturing Organization) is a strategic partnership that allows international medical device companies to manufacture products using pre-qualified facilities in China, without the capital burden of building their own factory. MTL identifies suitable partners, negotiates manufacturing agreements, guides the NMPA manufacturing license application, and provides ongoing quality oversight. Typical cost range is $50K–$200K for contract setup and license facilitation, and time-to-market runs 6–12 months versus 18–24 months for a new facility.
Does my product need NMPA registration before starting CDMO manufacturing?
Manufacturing licensing and product registration are related but distinct workstreams that MTL typically coordinates in parallel — see NMPA Registration & Licensing for how the registration pathway works.
What happens after manufacturing is set up?
Once your CDMO partnership and manufacturing license are in place, products typically move into Megalith's nationwide distribution network covering hospitals, clinics, universities, and regional distributors across China.
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