Question and Answer for Registration of Medical Devices,IVDs

Others, Uncategorized / By

Q: What materials are included in the annex to the clinical trial report of in vitro diagnostic reagents? What are your requirements? According to the “Announcement on Publishing the Requirements for Registration Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents” (formerly China Food and Drug Administration Announcement No. 44 in …

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” Notice on the Implementation of GB 9706.1-2020 and Supporting Collateral Standards and Special Standards”

Standard / By

Recently, the State Food and Drug Administration issued the “Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards” (No. 14 of 2023, hereinafter referred to as the “Notice”). The background and relevant content of the announcement are hereby explained as follows: 1. Background GB 9706.1-2020 and supporting parallel standards …

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The second interpretation of the “Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards”

Standard / By

1. For products registered before the date of implementation of GB 9706.1-2020 and supporting parallel standards and special standards (hereinafter referred to as the new version of GB 9706 series standards), how to continue the registration? The “Notice on the Implementation of GB 9706.1-2020 and Supporting Collateral Standards and Special Standards” (No. 14 of 2023, …

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Guangdong Province held a research symposium on the construction of the medical device database

NMPA News / By

Event On June 20th, in order to comprehensively implement the Party Central Committee and Provincial Party Committee’s deployment requirements for carrying out thematic education on studying and implementing Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, as well as the Party Central Committee’s decision to promote investigation and research throughout the …

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Head and Neck X-ray Stereotactic Radiosurgery System Approved for Marketing

NMPA / By

On June 20, the NMPA approved the registration application for the innovative product “Head and Neck X-ray Stereotactic Radiosurgery Therapy System” produced by Ruipu Surgical Systems Co., Ltd. Product Information The product consists of 3MV medical linear accelerator, inclined axis and vertical axis frame, X-ray high voltage generator, X-ray tube assembly, X-ray detector, treatment bed, …

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How to effectively control the quality of medical device software

Medical Device Software / By

Medical Device Software Quality Control With the rapid development of information and communication technology, the application of software in medical devices is becoming more and more common and its role is becoming more and more important. The development forms are flexible and changeable, and new technologies emerge in an endless stream. However, the accompanying quality …

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Guidelines for filling in application materials for classification and definition of medical devices

Guidelines / By

1. Purpose In order to implement the relevant requirements of the State Food and Drug Administration for the management of medical device classification, guide the applicants for the classification and definition of medical devices to fill in the application materials and supplementary materials (hereinafter referred to as the application materials), according to the “General Office …

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Key Points of Technical Review of Laparoscopic Surgical System

Guidelines, Technical Review / By

In order to further standardize the management of laparoscopic surgery systems, the CMDE organized the revision of the “Key Points for Technical Review of Laparoscopic Surgery Systems” (2023 revision), which is hereby released: Key Points of Technical Review of Laparoscopic Surgical System(2023 revision) This review point is intended to guide registration applicants in the preparation …

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The 2023 medical device industry standard formulation and revision plan project release

Standard / By

On May 24, the General Department of the NMPA issued a notice on printing and distributing the 2023 medical device industry standard formulation and revision plan: In order to implement the “Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capabilities” issued by the General Office of the State Council and the relevant requirements …

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