(Yicai Global) March 23 – The Covid-19 outbreak has spread to many countries around the world. The World Health Organization estimated that 89 million medical masks are needed every month worldwide for the epidemic. With the full expansion of production capacity by Chinese mask manufacturers and effective control of the epidemic within, the face mask shortage in China has been significantly eased. Having met domestic demand, mask manufacturers are now aiming for overseas markets.

However, Chinese firms still face a series of difficulties in export qualification and overseas certification for medical protective materials, including masks and protective clothing.

Popular medical export qualifications

Wu works for a large-scale mask manufacturer with more than 20 years of history. The company's medical masks are now sold all over the world, Wu told Yicai Global, adding that "except for Italy, which is in lockdown, we have successfully exported to North and South America, Australia, New Zealand and other Oceania countries."

"We have qualifications for export," he said. "We can deliver masks to customers' designated locations through cross-border platforms such as DHL, UPS and Taobao Global."

But, many companies temporarily transitioning to making masks face difficulties in exporting. Due to the higher safety and technical requirements for medical masks, firms need to obtain a medical device registration certificate from the National Medical Products Administration of China to export them.

Companies need to submit a series of information, including a list of professionals, and sterile workshop facilities, for the certificate, according to industry insiders. The approval process currently takes about 20 days.

China had a total of 47,000 companies producing masks and operating normally as of March 18, of which 8,950 were established after the Covid-19 outbreak on Jan. 25, according to data from corporate information platform Tianyancha. These firms also need to obtain relevant certificates if they wish to export.

Changeable European and American certification market

The CE certification and US Food and Drug Administration certification are stepping stones for Chinese mask manufacturers to enter the European and American markets.

Some overseas customers really value the certification of masks, Wu revealed. "Some customers would first ask if we have CE or FDA certificate rather than inquire about the quality of the mask. Others who know the business better directly inquire about one of the certificate number and order products with the number only," he said. "But to apply for this number the company has to register with the overseas local government and set up an independent local office there. Most Chinese mask makers produce domestically and do not have offices overseas, so few companies have the certification number."

The certification process has accelerated now, provided all submitted materials are complete, Ni, who specializes in export certification of masks, told Yicai Global. For example, the European Union's CE certification takes only 7 working days at its fastest; earlier it used to take months. The FDA certification takes 14 working days, much faster than before. The CE certification costs more than CNY30,000 (USD4,215) now, and the FDA certification more than CNY20,000. The lowest pre-epidemic price for these certificates was only CNY8,000.

With the epidemic in Europe and the United States worsening, the certification agencies cannot find people to work, Ni noted. Take the EU market as an example, Ni's agency has nearly 20 partners in Europe but "currently only one Italian company can take orders".

According to Chinese customs Europe and the US have issued a series of temporary or emergency measures for the supervision of epidemic prevention and control materials, relaxing access requirements in order to ease supply and demand imbalance. The EU now allows companies to enter the market before obtaining the CE certificate while the certification process continues. The US also said that firms can apply to the FDA for Emergency Use Authorization for their products.

The global demand for protective materials such as masks is expanding. The first batch of 8 million China-made European-standard medical protective masks meant for export to Italy have been arriving in Beijing since March 20 and will be chartered to Italy soon.

On March 21, LVMH Moet Hennessy Louis Vuitton, the world's largest luxury goods group, said it would order 40 million masks from China to supply to the French health department and 39 French public hospitals. The first 10 million masks, with an order value of EUR5 million (USD5.3 million), will be delivered in the coming days. The rest will be delivered within four weeks.

Editors: Zhang Yushuo, Chen Juan, Peter Thomas