Efforts to cut review time for medical equipment pay off

  • 2023-01-03

Shanghai has had nine innovative medical apparatus and instrument products approved and on the market this year.

These include heavyweights such as a laparoscopic surgery robot and a domestic-made proton therapy system, both the first of their kind in their fields in the nation, the Shanghai Drug Administration has announced.

So far, Shanghai has 33 registration licenses obtained in terms of innovative medical apparatus and instruments, according to the administration.

The latest is a medical X-ray angiography equipment developed and produced by Shanghai United Imaging Healthcare Co Ltd, which has been approved by National Medical Products Administration, China's top drug administrator.

The equipment is applied for angiography and provides fluoroscopy, vascular subtraction image and tomography. It can significantly amplify cone-beam CT reconstruction visual fields, cut operation procedures, duration and radiation dosage of cone-beam CT scan, thus improving surgery efficiency.

In recent years, the city's drug regulation authorities have taken a raft of measures to fuel innovation momentum in the medical apparatus and instruments area and help innovation products hit the market.

Efforts are made to tackle difficulties in innovative medical apparatus and instruments' registration, clinical tests and report.

Under combined efforts, the review time of registration has been significantly cut for medical apparatus and instruments registered in Shanghai.

(Source: SHINE   Editor: Yang Meiping)

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