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Medical Devices

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Consulting
Pre-market
China Product Regulations and Technical Path Consultation
QMS(Quality Management System)
China QMS Counselling
China Medical Device Distribution QMS Counselling
Training and Other Consulting Services
China Domestic Agent Service for Imported Medical Devices
Perennial Regulatory Consultant for Medical Devices in China
Entrusted R&D and production services
Medical Device R&D Support
Master Files Submission
Master Files Submission of Raw Materials in China
Master Files Submission of Pharmaceutical Excipients in China
Master Files Submission of Pharmaceutical Packaging Materials in China
Technical Support for R&D
Safety Evaluation of Leachable Substances in China
Technical Support for Product Pre-test and Rectification in China
Risk Evaluation and Management
Medical Device Registration
Product Classification
Product Classification Determination Request
Medical Device Filing/Recording and Registration
Class I Medical Device Filing/Recording
Class II/III Medical Device Initial Registration
Class II/III Medical Device Registration Change
Technical Files Compilation
Testing
Product Testing Rectification Technical Support
Other Services
Medical Device Registration Under the MAH System
Registration of Imported-to-domestic Products
Follow-up and Correction of Medical Device Registration Technical Review
Clinical Evaluation & Clinical Trial
Clinical Evaluation (Non-trial Method)
Clinical Evaluation Report for Products that are Exempt from Clinical Trials
Clinical Evaluation Report for Adopting Clinical Trials or Clinical Application Data of the Same Variety Products
Clinical Evaluation Report for Adopting Overseas Clinical Trials Data
Clinical Evaluation Report for Adopting Real-world Data
Clinical Trial
Clinical Trial Documentation Preparation
Clinical Trial Audit
Clinical Trial Statistical Analysis
Clinical Trial Data Management
Implementation and Management of Clinical Research Projects
Pre-clinical Animal Experiment
Pre-clinical Animal Experiment
FDA
FDA Medical Device Certification
Medical Device Safety Evaluation and Testing
Chemical Characterization of Materials
Chemical Characterization of Materials
Safety Evaluation for Extractables & Leachable Substances
Safety Evaluation for Extractables & Leachable Substances
Biocompatibility Testing
Biocompatibility Testing
Microbiological Testing
Microbiological Testing
Validation of Cleaning,Disinfection, Sterilization
Validation of Cleaning, Disinfection, Sterilization
Restricted Substance Testing
Restricted Substance Testing
Cleaning Room Environment Validation and Process Water Testing
Cleaning Room Environment Validation and Process Water Testing