Abbott's Alinity i Fully Automated Chemiluminescent Immunoassay Analyzer Receives Chinese Registration Certificate for Local Production

Sep 06, 2024 18:09 CST Updated 18:09

Abbott

Provider of Health Diagnostic Products and Health Diagnostic Management Solutions

Abogen

Nucleic Acid Drug Developer

Source:Hangzhou Market Supervision Administration

On September 3, 2024, Abogen BioMedical (Hangzhou) Co., Ltd. (hereinafter referred to as Hangzhou Abogen) received the "Alinity i Fully Automatic Chemiluminescence Immunoassay Analyzer Product Registration Certificate" delivered by the Zhejiang Provincial Drug Administration. This marks the successful implementation of Hangzhou's first imported medical device localized production project and signifies that the localization of a multi-sample fully automatic rapid testing platform in Hangzhou has become a reality.

The multi-sample fully automatic rapid testing platform has long been a market dominated by leading diagnostic companies such as "Abbott" and "Mindray." Since "Hangzhou Abogen" officially launched the localization project of Abbott's Alinity i fully automatic chemiluminescence immunoassay analyzer in December 2023, the Hangzhou authorities have organized precise对接services. Guided by the Zhejiang Provincial Drug Administration's "Guidelines for Simplifying the Registration Application Process for Class II Medical Devices Already Marketed Outside the Province (Trial)" (referred to as: 23 Measures for Medical Device Safety Development), the company has facilitated production line conversion, integration of domestic and international systems, and registration application. From the official launch of the project in December 2023 to receiving approval on September 2nd, it took only 9 months, with less than 3 months from entering the registration process to obtaining certification!

Next, the Hangzhou Bureau will continue to implement the device safety development policy, provide precise services, enforce strict supervision, optimize the development layout of Hangzhou-produced medical devices, and support the high-quality development of our city's medical device industry.

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