Zi-Medical Overview

We are dedicated to helping you

See Our Recent Blop Posts

Zi Medical provides services globally to medical device, IVD and pharma companies including:  See our company overview.

  • Pre-submission Consultations and Fillings
  • International Regulatory Strategy for One or Multiple Markets or Products
  • International Product Registration and License Renewal
  • GMP/QSD Registrations
  • Regulatory Management Development
  • Quality Compliance
  • Regulatory Staff Training
  • Process Improvement, Six Sigma
  • Regulatory Information Technology Strategy

Major Regions covered include: 

US, EU, China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, Mexico, Argentina, Brazil.

Importing medical devices into China requires a Medical Device Registration Certificate (MDRC) issued by the China Food and Drug Administration (CFDA). This document is technically owned by the foreign manufacturer, but is controlled by the Legal Agent listed on the certificate who is responsible for the registration application. Products must have...