Service Scope


Classification Identification

Entrusted Testing

Registration Consultation

Innovation Submission

Clinical Evaluation Reports (CER)

CER (Equivalent Devices)

CER (Overseas Clinical Data)

CER (Exemption from Clinical Evaluation)

Clinical Trials

Medical Writing

Safety Vigilance

Medical Monitoring

Clinical Monitoring

Project Management

Application for Human Genetic Resources

Imaging Core Lab

Data Management


Filling with Provincial Medical Products Adminstration

On-site Inspections


Regulatory Submissions

Registration Submission

Supplemental Submission Support

Renewal or Change of Registration Certificate

Post-Marketing Studies

Real-World Studies

Investigator-initiated Clinical Studies