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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.
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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.
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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.
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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.
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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.

Call for feedback on two standards for medical device industry

2023年09月05日

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Today, in line with the work plan of the National Medical Device Clinical Evaluation Standardization Technology Centralized Unit for standard formulation in 2023, the unit has finalized two industry standard solicitation drafts. These drafts are titled "Quality Technical Specifications for Clinical Trials of Medical Devices" and "Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents". The unit has commenced the public solicitation of feedback and opinions from the wider society.

Here's the information regarding the public solicitation of opinions for the two industry standard solicitation drafts:

Clinical Trials of Medical Devices - Quality Technical Specifications:


name
Proposed implementation date
Contact
Deadline for Feedback
Quality technical specifications for clinical trials of in vitro diagnostic reagentsImplemented 12 months after release

Liu Lu

Phone: 010-86452501

Email: liulu@cmde.org.cn

Before October 31, 2023
Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic ReagentsImplemented 12 months after releaseHe Jingyun

Phone: 010-86452544

Email: hejy@cmde.org.cn

Before October 31, 2023

If you have any comments or feedback on these drafts, please provide them via email before the specified deadline. Your input is valuable in ensuring the quality and effectiveness of these industry standards.