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Batch of Innovative Medical Devices Undergoes Special Review Process

Announcement, CMDE, Latest News / By Alice

Document Number: No. 1 of 2024 On January 22, 2024, the China CMDE announced that seven innovative medical devices, including the cardiac pulse electric field ablation system of Insight Lifetech Co., Ltd., and the interventional ventricular assist system of Xinqing Medical (Suzhou) Co., Ltd., have entered the special review process. Special Instruction: Entry into the …

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China NMPA issued an announcement

Announcement, NMPA, NMPA News / By Alice

Document Number: No. 150, 2023 On December 15, 2023, NMPA released an announcement regarding the trial implementation of emergency use management regulations for medical devices. These regulations were formulated by NMPA to address major public health emergencies and other serious crises, providing guidance on the emergency use of medical devices. In the event of significant …

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The China CMDE has released a draft of the Guideline for the Registration review of Monkeypox Virus Nucleic Acid Detection Reagents

CMDE, Draft for Comments, Guidelines, Latest News / By Alice

Date Issued: January 18, 2024 This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the …

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The China CMDE issued guideline for real-world research design and statistical analysis of medical devices

Announcement, CMDE, Guidelines, Latest News / By Alice

Document Number：No. 3, 2024 Date Issued: January 15, 2024 To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics）. …

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China CMDE has issued 613 guidelines for medical device registration review

CMDE, Guiding Principles / By Alice

Release date:2024-01-09 The Guiding Principles for Medical Device Registration Review (hereinafter referred to as the Guiding Principles), as a new tool, method, and standard for medical device technical evaluation, play an important role in improving scientific evaluation capabilities and promoting the high-quality development of the industry. CMDE adheres to the principle of scientificity and constructs a …

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Proton therapy system approved by China NMPA

NMPA, NMPA News / By Alice

Release date:2023-12-28 Recently, the innovative product Proton Therapy System of Varian Medical Systems Inc. is approved by China NMPA. This product is composed of proton accelerator subsystem and treatment subsystem. The proton accelerator subsystem consists of 3 major components: main proton accelerator system, energy selection system and beam transport system. The treatment subsystem contains 3 …

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Transcatheter mitral valve clamp system approved for marketing

Announcement, NMPA News / By Alice

Release date: 2023-11-30 Recently, the China NMPA approved the innovative product registration application for the “Transcatheter Mitral Valve Clamp System” of Hangzhou Dejin Medical Technology Co., Ltd. This product consists of two components: the guiding sheath and the mitral valve clamp system. Among them, the mitral valve clamp system includes a mitral valve clamp and …

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China NMPA Update the Quality Management Specifications for Medical Device Operations

Announcement, NMPA, NMPA News / By Alice

Release date: 2023-12-07 In order to strengthen the quality management of medical device operations, standardize medical device operations, promote the development of industry standards, and ensure the safety and effectiveness of medical devices used by the public, in accordance with relevant laws and regulations, the China NMPA has revised the “Quality Management Specifications for Medical …

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Cryoablation equipment and balloon cryoablation catheters approved by China NMPA

Announcement, NMPA, NMPA News / By Alice

Release date: 2023-12-05 Recently, the China NMPA approved the registration application for innovative products “cryoablation equipment” and “balloon cryoablation catheter” produced by Kangfeng Biotechnology (Shanghai) Co., Ltd. “Cryogenic ablation equipment” consists of a freezing device, a vacuum system, a low-temperature fluid delivery circuit and a control system. The “balloon cryoablation catheter” consists of equipment connection …

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Notice on the classification definition of “degradable expandable hemostatic sponge” products

Announcement, NMPA, NMPA News / By Alice

Release date: 2023.12.06 In order to further clarify the management attributes and categories of “degradable expandable hemostatic sponge” products, the China NMPA notice as follows: 1. “degradable expanding hemostatic sponge” products are polyether-type polyurethane sponges, which are composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer and are disposable. Products have been sterilized by irradiation and should be sterile. …

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