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  Published Paper Details:

  Paper Title

CLINICAL EXAMINATION OF MEDICAL DEVICES AND THEIR APPROVAL PROCESS IN CHINA

  Authors

  Waseem Khan,  Dr. K.S. Salunkhe,  Atul Bhombe

  Keywords

Medical device, Clinical examination of medical device, medical device regulation, regulatory frameworks

  Abstract


To deploy innovative medical devices for the treatment and diagnosis of a variety of ailments, the safety of the global population is the top priority. Industry innovation and regulations collaborate to create devices for a variety of global markets while also improving the quality and safety of existing devices on the market. The most important factor for devices is to categorize the real regulatory pathway that guarantees that safety protocols and other regulatory criteria are met in a given jurisdiction. We conduct clinical studies for medical devices that are significantly different from those conducted for drug testing. The new NMPA regulation requires manufacturers of high-risk devices to submit a comprehensive overview of their data. The clinical trials regulation makes clinical trial data more transparent. In China, medical devices are regulated by China food drug, and administration. The Chinese medical device business, like the Chinese economy, is growing rapidly. For the best chance of making educated judgments about new medical devices, complete transparency is necessary.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2205403

  Paper ID - 219900

  Page Number(s) - d583-d594

  Pubished in - Volume 10 | Issue 5 | May 2022

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Waseem Khan,  Dr. K.S. Salunkhe,  Atul Bhombe,   "CLINICAL EXAMINATION OF MEDICAL DEVICES AND THEIR APPROVAL PROCESS IN CHINA", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.10, Issue 5, pp.d583-d594, May 2022, Available at :http://www.ijcrt.org/papers/IJCRT2205403.pdf

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ISSN: 2320-2882
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Journal Starting Year (ESTD) : 2013
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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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