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The battle against 2019-nCoV

Today, 1 month after Chinese authorities alerted the WHO to an outbreak of pneumonia of unknown aetiology in Wuhan City, Hubei Province, the reported affected patient number is reaching 10.000 confirmed and over 12.000 suspected cases throughout the country. Of the confirmed cases, around 15% are severe and over 200 people have died. 

While facing the Wuhan-2019-nCoV challenge, China government took very strong measures and comprehensive multi-sectoral approaches to prevent further spread. Isolate and treat cases, trace contacts, and promote public awareness of the risk. We may have heard of the restriction of people’s movement and group entertainment during the Spring Festival to avoid cross infections. And recently China announced to extend the holidays a second time. The biggest challenge encountered is the difficulty of detecting the infection. Some people don’t have any symptom (such as fever, cough etc.) at all when they start to infect others.  

Since the affected numbers increased dramatically, medical supplies become a big concern. But how big the gap is? Let’s take mask as an example. According to the official statistic from MIIT (Ministry of Industry and Information Technology of the P.R.C.), China’s maximum capacity of mask production is about 20 million masks per day, which is estimated to account for 50% of global mask production capacity. We know how many people China has, but how many people do we have in Wuhan? 11 million in according to 2018 statistic data! Besides, everybody would expect to have at least 2 masks per day as it needs to be changed every 4 hours. I will not do a calculation here as the huge gap is quite obvious; there is even not enough for Wuhan citizen, nevertheless to say all Chinese. No data are available yet for gown production capacity, but there’re many doctors choose to eat once a day just to avoid changing their gowns into new ones.

NMPA, as well as local authorities, performed a dedicated review of relevant products to speed up the product launch. With the strong manufacturing power throughout the country & labourers’ return after the long holiday, we believe the shortage situation will be relieved in the coming month. Till today, 7 local manufacture’s 2019-nCoV testing kits been approved since Jan.26 using fast track submission. Vaccine research is on its way.

To make sure medical supplies could be used for people needing them the most, China’s central government took over domestic production facilities & supplies; dedicated authority staff supervise onsite daily the production & distributions. Although workers gave up their holidays, and machines run 24 hours a day, it’s still not enough, which of course is not a surprise.

While facing the shortage of necessary devices, Municipal government could decide to import Non-NMPA registered medical device for Emergency use. Many companies & organizations kindly provide free services, including flight transportation, customs clearance, domestic transportation etc. for oversea donations. More & more oversea Chinese people heard the news, enthusiastically to help their hometown, crazy purchasing consequently shocked the global medical protections products industry very quickly. At the same time, many non-medical manufacturers tried to catch some business and disturbed the market, therewith make lots of purchased/donated products useless for healthcare protective purposes, which is very sad. I volunteered to support screening the suppliers & help them to understand what the government’s requirements are. Although there’s not a strict alignment yet among cities/hospitals, purchasing requirements are getting closer.

EU/US/Japan registration(s) is generally expected if there’s no valid NMPA approval. Market entry could well be possible without those registrations if the products are compliant with following standards, realising national testing labs will be involved to perform the test for such cases.

The most urgently needed supplies:

Product

China

USA

EU

Japan

ISO

Respirator / mask

GB 19083 or

YY0469

FDA 510K or

ASTM F2100 level 2/3 barrier

EN 14683 Type IIR

JIS T8062

ISO 22609

Protective Clothing

GB 19082

ASTM F1670 & ASTM F1671

EN 14126

JIS T8062

ISO 22609

Eye protectors

GB 14866

ANSI Z87.1

EN 166

JIS T8147

ISO 4849

Examination gloves

GB 10213

ASTM D 3578

EN 455-1/2/3/4


ISO 11193-1

Rubber surgical gloves

GB 7543

ASTM D 3578

EN 455-1/2/3/4


ISO 10282

 

We hope our clients & global manufactures could be aware of the situation as soon as possible, well prepared for productivity improvement as the virus will impact not only China but soon globally, which may include your local community. There are now over 200 cases in 22 countries. There has been human-to-human transmission in several countries outside China. and yesterday, WHO declared the new Coronavirus outbreak a “Public Health Emergency of International Concern”.

If you’re interested to support China, please make sure you have the required documents on hand which will smoothen the purchasing. Your MDD/MDR CE certificate or US/Japan registration info; Declaration of Conformity, testing report & Chinese or English IFU would be required to enter into the fast track approval.

Please do not hesitate to contact me if you want to have more details or to talk with authorities or some other relevant organizations. I would be more than happy to support your communications, thank you for your support!

Minghua Chen
Post date: January 31, 2020
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