Global Registration Consultation - Zhejiang UE Medical Corp.

Full-Cycle Partner for Compliant Market Launch of Medical Devices
Fifteen Years of Deep Expertise, Dedicated to Your Compliance and Efficiency

With 15 years of deep experience in medical device registration, UE's Registration Team focuses on regulatory submission and approval. Leveraging extensive hands-on expertise, we provide full lifecycle registration solutions to ensure your products achieve compliant and efficient market launch.

Core Services

Full-Process Empowerment for Medical Device Registration
Professional Expertise to Support Your Compliance Journey

Registration Application

Regulatory Consulting

Device Classification & Definition Assessment

Registration Dossier Preparation

Registration/Filing Application

Manufacturing License Application

Registration Testing

Pre-Testing

Laboratory Selection

Documentation Preparation

Process Coordination

Report Acquisition

CCC Certification

Testing Lab Selection

Documentation Preparation

Process Coordination

Certificate Acquisition

Animal Studies

Facility Selection

Protocol Design

Documentation Review

Process Coordination

Report Acquisition

Quality Management System

System Establishment, Optimization & Compliance Review

Internal Auditor Training & System Operation Guidance

Audit Preparation & Non-Conformity Corrective Action Support

Medical Device Registration System Audit

Quality System Documentation Review

Pre-Audit & Mock Inspection for Registration System On-Site Review

Non-Conformity Correction & Compliance Enhancement

Medical Device Manufacturing License System Audit

Compliance Guidance for Manufacturing License (incl. Facility, Equipment, Process Validation)

Good Manufacturing Practice (GMP) Compliance Review

Audit Strategy & Key Issue Response

Medical Device Contract Manufacturing System Establishment

Quality Agreement Review Between Contract Giver & Contract Acceptor

Contract Manufacturing Quality Management System Setup

On-Site Audit & Compliance Assessment of Contract Manufacturer

Core Strengths

Leveraging a foundation of professional expertise and a specialized system
Efficient and Hassle-Free Medical Device Registration

Experience Advantages

15+ Years

Experience in the Medical Device Industry
50+ Cases

Medical Device Registration Experience
10+ Cases

CCC Certification Experience
76 Working Days

UE's Average First-Time Registration Cycle for Class II Medical Devices
56 Working Days

UE's Fastest Registration Cycle
Comprehensive Testing Support

Significantly Improves First-Pass Test Approval Rate
Shorter Testing Cycles

Average testing cycle significantly shortened, setting an industry benchmark

System Advantages

High-Frequency Audit Success

Passed all 20 audits in 2024
Zero-Defect Audits

Passed 4 audits with zero defects in 2024
System Establishment

Proficient in GMP and ISO 13485 Quality Management Systems
Internal Auditor Qualification

UE holds internal auditor qualifications for medical device registration