Alice

Guidelines for Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III)

In order to further standardize the management of medical X-ray diagnostic equipment (Class III), the Center for Device Evaluation of the State Food and Drug Administration organized the formulation and release of the “Guidelines for Clinical Evaluation and Registration Review of the Same Type of Medical X-ray Diagnostic Equipment (Class III)”. Scope of application This …

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Update for medical device standard GB9706

Standard / By Alice

In accordance with the requirements of the “Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Work Plan for the Implementation of GB 9706.1-2020 and Supporting Parallel Standards and Special Standards”, in order to fully understand the bottom line, the China Inspection Institute has made statistics as …

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Summary of medical device technical review work in July 2023

NMPA, Technical Review / By Alice

The CMDE implements the decisions and deployments of the Party Central Committee, the State Council and the bureau’s party group, and conducts technical review, pre-review of supplementary materials, medical device technical consultation, approval of some administrative approval items, registration certificate number and data circulation, etc. in accordance with functions and procedures. various tasks. Status of …

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Medical Devices Compliance Q&A

Others / By Alice

Question: How to choose the extraction solvent in the study of the extraction performance of contact lens products? Answer: It is recommended to choose the solvents recommended in Table 2 in GB/T11417.7 “Test Methods for Physical and Chemical Properties of Contact Lenses”. It is recommended to choose different types of solvents, which are mild extraction …

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Medical Device Production Management – Supervision and Inspection Requirements

Guidelines, Others / By Alice

There are three scenarios for the key inspection contents when medical device manufacturers carry out supervision and inspection: For medical device registrants and filers who produce by themselves: 1. The implementation of laws and regulations, medical device production quality management regulations by medical device registrants and record holders; 2. Organize production in accordance with mandatory …

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Medical devices UDI implement of the second batch

NMPA, NMPA News / By Alice

The first batch: 69 varieties of 9 categories in the class III of high-risk medical devices have been implemented since January 1, 2021. The second batch: the rest of the class III medical devices (including in vitro diagnostic reagents). The second batch of unique identification (UDI) for medical devices has been implemented from June 1, …

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2022 Medical Device Registration Data in China

NMPA News / By Alice

Data statistics from January 1, 2022 to December 31, 2022 In 2022, the State Food and Drug Administration continue to focus on people’s health, continue to do a good job in the review and approval of epidemic prevention and control products, comprehensively deepen the reform of the medical device review and approval system, strengthen the …

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“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)”

Announcement, NMPA, NMPA News, Others / By Alice

In order to fully implement the main responsibility for the quality and safety of medical device registrants, prevent and control the hidden risks of medical device entrusted production, and strengthen the supervision of medical device entrusted production, the State Food and Drug Administration organized the drafting of “Opinions on Further Strengthening the Supervision of Medical …

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Interpretation of “Guiding Principles for Registration Review of Medical Device Animal Test Research”

Interpretation / By Alice

The State Food and Drug Administration issued the “Guidelines for the Registration and Review of Animal Experimental Research on Medical Devices Part I: Decision-Making Principles (2021 Revision)” and “The Second Part of the Guidelines for the Registration Review of Medical Device Animal Experimental Research: Experimental Design and Implementation Quality Assurance” (Notice No. 75 of 2021) …

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Interpretation of “Classification Rules for In Vitro Diagnostic Reagents”

Interpretation / By Alice

1. Drafting background The classification of medical devices (including in vitro diagnostic reagents) in my country implements the classification catalog system under the guidance of classification rules. Classification rules and classification catalogs coexist, and the classification catalog takes precedence. Different from the “Medical Device Classification Rules”, the Bureau did not issue the classification rules of …

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