Alice

Interpretation of “Quality Management Standards for Clinical Trials of Medical Devices”

The “Quality Management Regulations for Clinical Trials of Medical Devices” (Announcement No. 28 of 2022, hereinafter referred to as “the Regulations”) has been released and will come into force on May 1, 2022. The revision background, main content and key revisions of the Specification are now interpreted as follows: 1. Amendment background In 2016, the …

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Interpretation of medical device registration self-inspection management regulations

Announcement / By Alice

The “Regulations on the Administration of Self-inspection of Medical Device Registration” organized by the State Drug Administration (National Drug Administration Announcement No. 126, which will come into force on the date of issuance, hereinafter referred to as the “Regulations”), has been issued on October 21, 2021. The background, main content and key issues of the …

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Attention should be paid to the production of products that have obtained the registration certificate of imported medical devices in enterprises in China

NMPA / By Alice

In order to further implement the State Council’s “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” and the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices” issued by the General Office of the Central Committee of the Communist Party …

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Explanation for the revision of “Class I Medical Device Product Catalogue”

Medical Device Catalogue / By Alice

In order to implement the requirements of the “Regulations on the Supervision and Administration of Medical Devices” (Decree No. 739 of the State Council) regarding the classified management of medical devices, deepen the reform of the medical device review and approval system, further guide the filing of Class I medical devices, and boost the development …

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14 Medical Device Product Registration Review Guidelines Released

Guidelines, Technical Review / By Alice

In order to further standardize the management of medical devices such as blood melting equipment, the Center for Device Evaluation of the State Food and Drug Administration organized and issued 14 guidelines for the registration and review of medical device products including the “Guidelines for the Registration and Review of Blood Melting Devices”: 1. Guidelines …

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Interpretation of “Administrative Measures for Medical Device Recall”

Others / By Alice

Paragraph 1 of Article 16 of the “Measures for the Administration of Medical Device Recall” stipulates that if a medical device manufacturer makes a decision to recall a medical device, it shall immediately submit a medical device recall event report form to the drug regulatory department of the province, autonomous region, or municipality directly under …

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Announcement of the NMPA on the release of documents such as the “Requirements for the File Review of Medical Device Product Registration Items”

Technical Review / By Alice

In order to further deepen the reform of the review and approval system and encourage the innovation of medical devices, in accordance with the “Administrative Measures for Registration and Filing of Medical Devices” (State Administration of Market Regulation Order No. 47), “Administrative Measures for Registration and Filing of Administration Order No. 48), “Announcement of the …

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2023 medical device industry standard formulation and revision plan

Standard / By Alice

2023 Medical device mandatory industry standard formulation and revision project plan serial number Standard Item Name standard nature revision was revised Standard adopt international Standard Responsible unit (Standard Committee/Technical Coordinator unit) 1 Medical Electrical Equipment Part 2-87: Particular Requirements for Basic Safety and Essential Performance of High Frequency Ventilators mandatory formulate / ISO 80601-2-87:2021 National …

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Non-Conformity of NMPA Unannounced Inspections

NMPA, NMPA News / By Alice

Recently, the State Food and Drug Administration organized an inspection team to conduct unannounced inspections on three companies including Tianjin Soma Technology Co., Ltd., and found defects in the quality management system of the companies. Details are as follows: 　1. Tianjin Soma Technology Co., Ltd. (1) Institutions and personnel Insufficient ability of inspectors to perform …

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Notice on Public Solicitation of Opinions on 3 Medical Device Registration Review Guidelines including “Guidelines for Clinical Evaluation and Review of the Same Type of Absorbable Surgical Sutures (Draft for Comment)”

Guidelines / By Alice

According to the relevant requirements of the State Drug Administration’s 2022 medical device registration review guidelines formulation and revision plan, the Center for Device Evaluation organized the compilation of 3 medical device registration reviews including the “Guidelines for the Clinical Evaluation and Registration Review of Absorbable Surgical Sutures of the Same Variety” The Guiding Principles …

Notice on Public Solicitation of Opinions on 3 Medical Device Registration Review Guidelines including “Guidelines for Clinical Evaluation and Review of the Same Type of Absorbable Surgical Sutures (Draft for Comment)” Read More »

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