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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
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
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
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.

Catalogue of Guiding Principles for Medical Device Registration Review released by the Equipment Review Center (as of the end of 2023)

2024年01月10日

In recent years, China has made significant strides in constructing its guiding principle system for medical devices. Both the quality and quantity of these guiding principles have notably improved, while their structural layout has been continuously refined. By the end of 2023, China had revised a total of 613 guidelines, offering comprehensive and multi-dimensional guidance for registration applications and technical evaluations.


Guiding Principles for Medical Device Registration Review (Excerpt)