China Launches List of Authorized Certifiers for Export Medical Goods

China’s market regulator has published a list of domestic companies authorized to certify the quality of medical supplies for export to the U.S. and European markets, after an overseas backlash prompted the government to rein in the export of substandard goods.

The list, launched by the State Administration for Market Regulation (SAMR) Sunday, follows other restrictions brought into effect on April 1 which require masks, ventilators, test kits and certain other medical products to be certified for use in the Chinese domestic market before they can be exported.

Speaking at an SAMR briefing on Sunday, ministry official Liu Weiju urged companies to only use “legal organizations” to apply for certificates for foreign markets.

Covid-19 has driven overseas demand for Chinese-made personal protective equipment for healthcare workers and the public, including masks, goggles, protective suits and more. That has been a boon for China’s army of middlemen competing to promise rapid certification of such products, in some cases under false pretenses.

One agent operating an online store on the e-commerce platform Taobao, who said he had been inundated with orders, outlined his business to Caixin last month, saying it collected samples from clients and helped them pass evaluation to get certificates such as the European Union’s CE mark. In some cases, even when samples failed to pass evaluation the agent could obtain certification if they agree to waive the agent’s responsibility, he said.

His company could guarantee clients CE certificates within three days and certificates from the U.S. Food and Drug Administration within about two weeks, the man said.

The agent appeared to have suspended services on Monday, when a Taobao search for his company’s name failed to return any results.

China has been grappling with negative press in multiple countries after its exported medical supplies were found wanting. The Dutch health ministry last month told hospitals to hand back 600,000 defective face masks imported from China, and Spain returned more than 58,000 test kits to the Chinese manufacturer after local researcher found they were less reliable than flipping a coin. Slovakian and Turkish officials last month also questioned the effectiveness of Chinese tests they had purchased.

Late last month, several ministries including China’s Ministry of Commerce announced that, beginning on April 1, exported medical supplies must be approved for the Chinese domestic market, as well as meeting the quality standards of the importing country or region.

The U.S.’s Food and Drug Administration said last week that it would allow the import of certain face masks that meet Chinese standards.

As of Friday, a total of five types of masks from two Chinese companies — Shenzhen-based automaker BYD and Guangzhou-based Weini Technology Development Co. Ltd. — had been green-lit for export to the U.S. under the FDA’s new rules.

Contact reporter Mo Yelin (yelinmo@caixin.com)