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.
Country
Medical device enterprises
Global offices
Our experienced global project management team, coupled with localized clinical operations teams, possess excellent cross-departmental, cross-regional, and cross-functional coordination abilities. As the primary point of contact for sponsors, project manager will ensure seamless coordination among all functional stakeholders throughout the project lifecycle.
Our clinical operation teams span across five continents, equipped with abundant and highly experienced local PD/PM/CRA professionals. They offer comprehensive strategic consultation for global regulatory pathways and clinical development plans tailored to local clinical operations and registration application.
We adhere to global unified SOP processes and budget management, compliance with ICH-GCP, local GCP, and all other applicable regulations. With experienced experts in NMPA, FDA, and EU regulations, we provide product development strategies that align with the requirements of multiple countries.
Establishing consolidated service centers in China enhances our cost advantage. Our service centers in China cover medical writing, registration, biostatistics, safety vigilance, central imaging, and more.
We have extensive coverage in the key markets of medical devices and can provide comprehensive end-to-end services.
Services that we offer
•Product development strategy
•Medical device testing
•GMP system counselling
•Clinical evaluation report
•Clinical study
•Regulatory affairs
•Invitro diagnostic product (IVD)
Services that we offer
•Product Classification Consultation
•TFDA Application
•Clinical Study
Services that we offer
•Product Assessment and Classification Consultation
•Local Responsible Person (LRP) Agent
•Voluntary Product Listing Requirements
•Clinical Study
Services that we offer
•Product Classification Consultation
•GMDN Code Research
•TGA Application
•Agent Service
•Clinical Study
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)
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)
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)
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)
Services that we offer:
•Product registration
•License holding capability and Import clearance
•Product Amendments
•PMS reporting (Complaints, Field actions)
•Distributor management (optional)
•Clinical Study
Services that we offer:
•Product Classification Consultation
•JMDN Code Research
•RCB Application
•PMDA Application
•Clinical Consultation
•Clinical Study
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
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
Services that we offer:
•Product Classification Consultation
•MDSAP and CMDER Consultation
•MDL Application
•MDEL Application
•Clinical Study
Services that we offer:
•CE Regulation Consultation
•Clinical Study
•MDR/IVDR Compliance
•Clinical Evaluation Report
•Vigilance
Obtain the latest industry and regulatory updates on a monthly basis.
Tel：+86-400-0739-391
Email：consult@tigermedgrp.com
Add：Suite 808, Union Plaza, Chaowai Street, Chaoyang District, Beijing
China Postal Code：100020
Copyright © 2017-2023 Tigermed-Jyton All Rights Reserved.
京ICP备2021039767号