Quality & Regulatory
Consultations & Services

Regulatory Compliance Services

• Design documentations, DHF, traceability.
• Supporting documentations creation related to NMPA,CE Mark, FDA application
• Coordination for 3rd party type testing with dedicated engineering support
• Support customer during product registration process
• Supporting customer to apply MAH contract manufacturing with proven experience
• Get approval for 1st MAH trail in Jiangsu Province for a sterilize disposable product
• Obtained 41 NMPA products via MAH pathway