NMPA

Guidelines – Clinical Evaluation of the Powered Laser Surgical Instrument

The guidance document was released on July 26, 2023. It’s the NMPA current thinking about the clinical evaluation of the Powered Laser Surgical Instrument. This guideline applies to powered laser surgical instruments intended to reduce human hair and wrinkles, treat hyperpigmented skin diseases and skin vascular diseases, and treat scars (Product Code 09-03-01, Class III). …

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Update! Medical Devices Clinical Evaluation Exemption Catalogue

Announcement / By Alice

On July 24, the NMPA issued the catalog of medical devices exempt from clinical evaluation: In order to do a good job in the management of medical device registration, according to the “Measures for the Administration of Medical Device Registration and Filing” (State Administration of Market Regulation No. Circular No. 71 of 2021), which is …

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

NMPA / By Alice

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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