Service

深耕中国 · 卓越全球

China’s changing regulatory environment and increasingly competitive landscape require medical device companies to develop a localized strategy to enter the Chinese market. As China's leading medical device CRO (including IVD), our expertise and enriched project experiences can help our clients to navigate cultural differences, monitor regulatory changes, and marketize our clients’ products in the most efficient and cost-effective way. Since 2000, we have collaborated with top 20 global medical device companies and worked with more than 600 clients overseas to successfully launch their products in China.


Globally, Tigermed-Jyton have established long-term cooperation with more than 1900 medical device R&D and manufacturing enterprises from more than 30 countries, and have set up more than 180 global offices worldwide. With our SOPs and QMS complying with global standards, we offer regulatory affairs and clinical trial services in all major markets. We have global teams of specialists and professionals expertizing in local regulations. With a solid team based in China, Tigermed-Jyton has cost advantages, offering top-tier services such as global study clinical operation, data management & biostatistics, medical affairs, and more. 


30 +

Country

1900 +

Medical device enterprises

180 +

Global offices

Our Service Advantages and Features
Covering 50+ Countries and Regions for Client Product R&D Globally

We have extensive coverage in the key markets of medical devices and can provide comprehensive end-to-end services.

Asia Pacific

  • China
    • Services that we offer

    • •Product development strategy

    • •Medical device testing

    • •GMP system counselling

    • •Clinical evaluation report

    • •Clinical study

    • •Regulatory affairs

    • •Invitro diagnostic product (IVD)

  • China Taiwan
    • Services that we offer

    • •Product Classification Consultation

    • •TFDA Application

    • •Clinical Study

  • China Hong Kong
    • Services that we offer

    • •Product Assessment and Classification Consultation

    • •Local Responsible Person (LRP) Agent

    • •Voluntary Product Listing Requirements

    • •Clinical Study

  • Australia
    • Services that we offer

    • •Product Classification Consultation

    • •GMDN Code Research

    • •TGA Application

    • •Agent Service

    • •Clinical Study

  • Singapore
    • Services that we offer

    • •Product registration

    • •Clinical Study

    • •Product Amendments

    • •License holding capability and Import clearance(except electromedical)

    • •PMS reporting (Complaints, Field actions)

    • •Distributor management (optional)

  • Indonesia
    • Services that we offer

    • •Product registration

    • •Clinical Study

    • •Product Amendments

    • •License holding capability and Import clearance(except electromedical)

    • •Stock holding in Warehouse, Labelling, Translations

    • •PMS reporting (Complaints, Field actions)

    • •Distributor management (optional)

  • Vietnam
    • Services that we offer

    • •Product registration

    • •Clinical Study

    • •Product Amendments

    • •License holding capability and Import clearance(optional)

    • •Stock holding in Warehouse, Labelling, Translations

    • •PMS reporting (Complaints, Field actions)

    • •Distributor management (optional)

  • Thailand
    • Services that we offer:

    • •Product registration

    • •Clinical Study

    • •Product Amendments

    • •License holding capability and Import clearance(optional)

    • •Stock holding in Warehouse, Labelling, Translations

    • •PMS reporting (Complaints, Field actions)

    • •Distributor management (optional)

  • India
    • Services that we offer:

    • •Product registration

    • •License holding capability and Import clearance

    • •Product Amendments

    • •PMS reporting (Complaints, Field actions)

    • •Distributor management (optional)

    • •Clinical Study

  • Japan
    • Services that we offer:

    • •Product Classification Consultation

    • •JMDN Code Research

    • •RCB Application

    • •PMDA Application

    • •Clinical Consultation

    • •Clinical Study

  • South Korea
    • Services that we offer:

    • •Quality System Consultation

    • •Regulatory Affairs

    • •Local Agent

    • •KGMP Application

    • •Clinical Study

    • •Product Import and Export Consultation

    • •Post-Market Surveillance

    • •Vigilance

    • •Product Full Lifecycle Management

    • •Medical Insurance Application

    • •Logistics Compliance

North America

  • United States
    • Services that we offer:

    • •U.S. Agent

    • •FDA Registration Pathway Planning

    • •FDA Submission and Communication

    • •Breakthrough Device Designation

    • •513(g) Classification

    • •510(k) Application

    • •De Novo Application

    • •RFD | Pre-RFD Application

    • •IDE Application

    • •PMA Application

    • •HUD | HDE Application

    • •Medical Insurance Application

  • Canada
    • Services that we offer:

    • •Product Classification Consultation

    • •MDSAP and CMDER Consultation

    • •MDL Application

    • •MDEL Application

    • •Clinical Study

European Union

  • European Union
    • Services that we offer:

    • •CE Regulation Consultation

    • •Clinical Study

    • •MDR/IVDR Compliance

    • •Clinical Evaluation Report

    • •Vigilance

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