About Us
Drawing on the unique characteristics of our customers' medical device products, we offer a tailored and personalized integrated service model that spans from preclinical to clinical research and registration consultation. Our aim is to provide comprehensive support throughout the product development lifecycle, ensuring the delivery of essential preclinical research data, conducting rigorous clinical research, and facilitating seamless registration declaration processes.
Business
Business
Drawing on the unique characteristics of our customers' medical device products, we offer a tailored and personalized integrated service model that spans from preclinical to clinical research and registration consultation. Our aim is to provide comprehensive support throughout the product development lifecycle, ensuring the delivery of essential preclinical research data, conducting rigorous clinical research, and facilitating seamless registration declaration processes.
Business Acceptance
Business Acceptance
Drawing on the unique characteristics of our customers' medical device products, we offer a tailored and personalized integrated service model that spans from preclinical to clinical research and registration consultation. Our aim is to provide comprehensive support throughout the product development lifecycle, ensuring the delivery of essential preclinical research data, conducting rigorous clinical research.
News Center
News Center
To best serve our customers' needs, we offer a personalized integrated service model tailored to the characteristics of their medical device products. This model encompasses a comprehensive range of services from preclinical to clinical research and registration consultation, ensuring the provision of essential preclinical research data, conducting robust clinical research, and facilitating seamless registration declaration processes.
Team Introduction
Team Introduction
Based on the unique features of the customer's medical device products, we tailor a personalized integrated service model spanning from preclinical to clinical research and registration consultation. This enables us to better assist customers by providing comprehensive support, including basic preclinical research data, clinical research, and assistance with registration declaration for the product.
In the first half of 2023, the Medical Device Registration Review Center undertook significant efforts to enhance the oversight and direction of medical device product registration processes. A comprehensive set of 30 guiding principles for medical device registration review was developed between January and June 2023. These guidelines were crafted with the aim of enhancing the quality of registration application materials and improving the efficiency of evaluation procedures.
Guidelines have been released in the first half of 2023
