Eleven Innovative Medical Devices Enter China's Special Review Program Ahead of IPO Filings

Sep 25, 2023 19:01 CST Updated 19:01

Wei Qiang Medical

Vascular Interventional Device R&D and Manufacturer

Century Healthcare

Medical Device Manufacturer, R&D, and Distributor

SIEMENS Healthineers

Medical Device Manufacturing Enterprise

UNITED IMAGING

Artificial Intelligence Medical Product Developer

Vision Pro

High-end Ophthalmic Consumables Developer

▍Source: Medical Device Technology Review Center, National Medical Products Administration

In accordance with 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. The following application projects are proposed to be approved to enter the special review procedure, and are now being publicly announced.

1. Product Name: Prostate Cancer MRI Image-Assisted Diagnosis Software

Applicant: SIEMENS Healthineers

2. Product Name: PlasmaSubdermal Skin Therapy Device

Applicant: Hefei Branch Ion Medical Technology and Equipment Co., Ltd.

3. Product Name: Auxiliary Detection Software for CT Angiography Images of Head and Neck Aneurysms

Applicant: United Imaging Intelligence Co., Ltd.

4. Product Name: Disposable Coronary Rotablator Device

Applicant: Jiaxing JX Medical Technology Co., Ltd.

5. Product Name: Interventional Left Ventricular Assist System

Applicant: Anhui Tongling Biomimetic Technology Co., Ltd.

6. Product Name: Minimally Invasive Myocardial Rotary Cutting System

Applicant: Wuhan Microxin Tan Medical Technology Co., Ltd.

7. Product Name: Single-Use Silicone Catheter

Applicant: Taizhou Dubomai Medical Device Co., Ltd.

8. Product Name: Abdominal Aortic Stent Graft System

Applicant: Hangzhou Wei Qiang Medical Technology Co.,Ltd

9. Product Name: Multifocal Intraocular Lens

Applicant: Wuxi Vision Pro Ltd.

10. Product Name: Multifocal Intraocular Lens

Applicant: Tianjin Century Healthcare Biomedical Engineering Co., Ltd.

11. Product Name: Human DNA Methylation Detection Kit (Reversible Terminator Sequencing Method)

Applicant: Burning Rock Biotech Ltd

Special Note: Entering the innovative review process does not mean that the product has been deemed to have the safety and effectiveness required for registration. The applicant must still carry out research and development and submit a registration application in accordance with relevant requirements. The drug regulatory authorities and related technical institutions will adhere to the principles of early intervention, designated personnel responsibility, and scientific review, ensuring that standards are not lowered and procedures are not reduced during the evaluation and approval process.

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