Service Platform
One-stop service platform
Professional and reliable, with heartfelt service.
ODM/OEM one-stop service
Technology transfer, registration support, physical examination support, production support, agency-based contract manufacturing, OEM contract manufacturing
One-stop service (CDMO)
Technology Transfer & Partnership
Pangu Medical can provide a comprehensive R&D documentation package tailored to market and client requirements. Our end-to-end technical support is designed to accelerate your product development cycle and expedite the regulatory registration process.
Registration Support
Leveraging the Medical Device Marketing Authorization Holder (MAH) system, we provide end-to-end registration services for Class II and III medical devices on behalf of our clients.
Regulatory Audit Support
We provide GMP compliance pre-audit and corrective action services to assist clients in preparing for and successfully passing the on-site quality system inspections conducted by the National Medical Products Administration (NMPA).
Production Support
Our GMP-certified Class 100,000 cleanroom and automated production lines enable us to provide closed-loop services spanning from pilot production to full-scale mass production.
MAH Commissioned Production
Under this model, the client acts as the Marketing Authorization Holder (MAH), responsible for product design, registration, and sales, and commissions the production. Pangu Medical, as the commissioned manufacturer, carries out the full-process manufacturing of the product.
OEM Contract Manufacturing
We offer comprehensive OEM mass production (private-label) services and can also serve as a component supplier. All manufacturing is strictly conducted in compliance with the client’s specified Quality Agreement for Contract Manufacturing.
Service Content
ODM/OEM One-Stop Service: Technology Transfer, Registration Support, Physical Examination Support, Production Support, Agency-Based Contract Manufacturing, OEM Contract Manufacturing