NMPA Announces Five Innovative Medical Devices Selected for Special Review (2026 No.11)

Pursuant to the "Special Examination Procedures for Innovative Medical Devices" (Announcement No. 83 of 2018 issued by the National Medical Products Administration), the Office for the Special Examination of Innovative Medical Devices has organized relevant experts to review applications for special examination. It is proposed that the following application projects be admitted into the special examination procedure, and this is hereby announced for public notice. The public notice period is from June 30, 2026, to July 14, 2026.

1. Product Name: Artificial Blood Vessel

Applicant: CAREVITA

2. Product Name: Ophthalmic Surgical Assistance System

Applicant: Guangzhou Oculotronics Medical Instrument Co., Ltd.

3. Product Name: Digestive System DNA Fragment Characteristic Detection Kit (Combined Probe Anchored Polymerase Sequencing Method)

Applicant: Geneseeq Medical Device and Diagnostic Inc

4. Product Name: Puncture Surgery Navigation and Positioning System

Applicant: Beijing Yiru Jingzhi Medical Technology Co., Ltd.

5. Product Name: Abdominal Aortic Stent Graft System

Applicant: Lombard Medical Co., Ltd.

During the public notice period, any entity or individual with objections may submit written comments to our center’s email address: gcdivision@cmde.org.cn.

Special Note:

1. This public notice does not serve as the basis for the aforementioned medical devices to enter the innovative review procedure; whether they enter shall be determined by the final review conclusion.

2. Entry into the innovative review process does not constitute a determination that the product has been found safe and effective for registration approval. Applicants are still required to conduct research and development and submit registration applications in accordance with relevant requirements. The 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, under the premise that standards are not lowered and procedures are not reduced.