Source: Siyu MedTech; Editor: Zhang YuqingReprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
On January 22, 2024, the Medical Device Technology Review Center of the National Medical Products Administration updatedPublic Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 1, 2024)AndPublic Notice of the Review Results for the Priority Approval Application of Medical Devices (No. 1, 2024)The original text is as follows:
# Innovation Approval Results
On January 22, 2024, the National Medical Products Administration (NMPA) released the "Announcement of the Review Results for Special Review Applications for Innovative Medical Devices (No. 1, 2024)." A total of seven devices are proposed to enter the special review process for innovative medical devices. The original text is as follows:
According to the requirements of the National Medical Products Administration's "Special Review Procedure for Innovative Medical Devices" (Announcement No. 83 of 2018 by the National Medical Products Administration), the Office for the Review of Innovative Medical Devices organized relevant experts to review the applications for special review of innovative medical devices, and proposed to approve the following application projects to enter the special review procedure, which are now being made public.1. Product Name: Cervical Artificial Intervertebral DiscApplicant: AK Medical Holdings Limited2. Product Name: Glaucoma Drainage DeviceApplicant: HSGD (Suzhou) Biomedical Technology Co., Ltd.3. Product Name: Cardiac Pulsed Field Ablation SystemApplicant: Insight Medtech Co., Ltd.4. Product Name: Interventional Ventricular Assist SystemApplicant: magAssist (Suzhou) Co., Ltd.5. Product Name: Ocular Muscle Nerve StimulatorApplicant: Super Vision Technology, Inc.6. Product Name: Endoscopic Single-Port Surgery SystemApplicant: Intuitive Medical Company7. Product Name: Nd:YAG Triple Frequency Laser Plaque Reduction DeviceApplicant: Shenzhen Zhongke Rongguang Medical Technology Co., Ltd.Publication Time:January 22, 2024 to February 4, 2024During the public announcement period, if any organization or individual has objections, they can be raised with the Comprehensive Business Department of our center via written communication, telephone, or email.Email:gcdivision@cmde.org.cnAddress:Building 1, No. 50 Meteorology Road, Haidian District, BeijingSpecial Note:Entering the innovative review process does not mean that the product has been recognized as having the safety and effectiveness required for registration. The applicant still needs to carry out research and development and submit a registration application according to relevant requirements. Drug regulatory authorities and related technical institutions will conduct evaluation and approval based on the principles of early intervention, dedicated personnel responsibility, and scientific review, without lowering standards or reducing procedures.#Priority Review Results
January 22, 2024Naslund Medical ABProduct "Soft Tissue Localization Gold Marker Kit"Obtained priority approval qualification for medical devices. It is reported that this product belongs to 'clinically urgently needed, and in China..."No medical device of the same type has been approved for registration.”。
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
