China has recently confirmed human-to-human transmission of a novel Wuhan coronavirus strain (2019-nCoV). As in January 24th, more than 850 cases of pneumonia-linked coronavirus have been confirmed in China, rising the death toll  to 26 people. Chinese authorities have locked down 13 cities across China and suspended the majority of transportation lines in several cities at the heart of the coronavirus outbreak. 

OSMUNDA Group successfully assisted Guangzhou Anjie Biomedical Technology Co., Ltd. in acquiring medical device approval for a respiratory infection isolation and control equipment (Medical isolation bed) to react to a major shortage of medical supplies and quarantine facilities. The application was filed through 'NMPA Review Procedure for Urgently Needed Medical Device', and approval was being granted on the same day of application submission.

Medical device supplies such as protective masks and new test kits for pneumonia are highly deficient, therefore local healthcare companies are currently putting immense effort in R&D and production to meet market demand and to tackle the outbreaks.Other protective supplies required for preventive measures include: N95 mask, disposable medical/surgical masks, protective face shields, disposable medical latex gloves, air filter respirator, infrared thermometer, etc.

With the escalation of the epidemic prevention and control level, overseas healthcare and medical devices enterprises are encouraged to apply and import the protective products to China as the demand for such medical devices continues to soar.

Contact us at global@osmundacn.com for regulatory consulting on how to obtain NMPA approval for urgently needed medical device in China.