Services

We help medical device companies meet registration requirements

in Japan and China markets.

One-Stop Service Solution

From the initial research & development stage right up to the final stage of obtaining approval from Japan PMDA and China NMPA, we see through your needs in providing consulting, ground work, coordination in supporting each step of the procedures of application.

Design input
Documentation preparation
Type testing
Clinical trail
PMDA/NMPA Evaluation
GMP Inspection
Approval/Labeling

Customized Consulting Service

On-site seminar
Technical support
Japan PMDA/China NMPA application path way
Gap analysis
QMS implementation
Negotiations with Japan PMDA/China NMPA
In-country representation
Clinical study compliance
Regulatory strategy

Annual Consulting Service

Basic Plan

Provide the latest information about Japan PMDA and China NMPA regulations each month
Analyzing the impact on your organization's products

Annual Consulting Service

Standard Plan

Provide the latest information about Japan PMDA and China NMPA regulations each month
Analyzing the impact on your organization's products
Conduct one hour/meetings two times a month

Annual Consulting Service

Premium Plan

Provide the latest information about Japan PMDA and China NMPA regulations each month
Analyzing the impact on your organization's products
Conduct one hour/meeting four times per month

Translation Service

Translation services in Chinese and Japanese

Satisfaction Guarantee

We guarantee customer satisfaction