BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.

Before the new rule, Chinese med-tech companies were not required to obtain NMPA approvals before exporting to other countries, as long as they had CE or FDA certificates. Now the Chinese regulators are trying to plug the loophole.

Starting April 1, 2020, exporters of medical products including COVID-19 test kits, medical face masks, protective clothing, ventilators and infrared thermometers are required to provide extra documentation when they go through customs clearance.

Exporters must declare in the document, in either print or digital form, that the products have been officially registered in China and meet the quality-control standards of respective export destinations.

The new requirement was put forward by the Ministry of Commerce, the General Administration of Customs China and the NMPA this week. The move came swiftly after a few countries, including Spain and the Netherlands, reportedly said Chinese test kits and medical masks and failed to work properly.

Shenzhen Bioeasy Biotechnology Co. Ltd.’s test kits, which were called “defective” by the Spanish authorities, are not registered with the NMPA but are said to be CE certified.

“We call on all Chinese suppliers to act in strict compliance with relevant rules and regulations and ensure qualities of exported products,” said the China Chamber of Commerce for Import & Export of Medicines and Health Products (CCCMHPIE) in an English statement. The chamber is under China’s Ministry of Commerce.

Released along with the statement was a list of NMPA-approved manufacturers of personal protective equipment and medical devices, which the chamber said could be used as a reference by all parties.

The CCCMHPIE is not the only government-affiliated organization in China starting to put out more English information. The China Association for Medical Devices Industry (CAMDI) also began to issue English notices on regulatory updates for COVID-19 test kits.

On March 30, it said the NMPA issued an emergency approval for a nucleic acid reagent test kit (fluorescence PCR) developed by a Shanghai company to increase the supply of detection reagents for epidemic prevention and control.

“So far, the NMPA has approved 15 nucleic acid reagent test kits and eight antibody reagent test kits for COVID-19,” CAMDI said in the English notice.

Currently, the NMPA has approved 23 test kits, 62 ventilators, 301 protective clothing, 150 medical masks, 523 surgical masks, 752 disposable medical masks and 236 infrared thermometers. The watchdog also released the lists of suppliers on its website.

On the same day, the NMPA also introduced regulatory standards for test kits, masks and protective clothing for COVID-19, in an attempt to enhance the quality of these much-needed medical supplies. Manufacturing can only begin after obtaining permission from the regulators.

Certification agencies pose problems

As the number of people infected with COVID-19 is soon to hit one million, Chinese med-tech companies are eager to export their products to meet the huge demand worldwide. Many of them have sought CE/FDA certificates in order to supply to markets other than China, areas that they have little experience in.

Experts told BioWorld that certification agencies have been issuing reports irresponsibly, making Chinese med-tech companies believe that their products are qualified for export.

Italy-based Ente Certificazione Macchine (ECM) is one of the problematic agencies, Chao Xu, co-founder of Berlin-based J Medtec Ltd., told BioWorld. Her company consults on matters regarding regulatory affairs and clinical trials.

“ECM is no longer qualified [to issue certificates] after the Medical Device Regulation took effect, but it issues review reports instead of certificates,” she said. “It has a disclaimer in tiny print that says it has attested the company’s technical documents, so it issues this review report, but it doesn’t mean it is qualified to issue certificates.”

“Chinese suppliers and foreign buyers may not understand this, so these Chinese products ended up in the market,” Xu explained.

BioWorld was approached by a Chinese middleman, who only disclosed his surname Wu, who claimed to be working with Guangdong Sunlight Medical Co. Ltd., a manufacturer of disposable medical masks in Southern China. He implied that the company could export to European countries such as Italy and Germany, and showed BioWorld review reports issued by ECM.

Guangdong Sunlight is not on the list of NMPA-approved manufacturers. When BioWorld called later again, Wu said the company no longer accepts new orders. Claiming to be an employee of Zhejiang-based Blue Cross Capital, the he refused to clarify whether Guangdong Sunlight is qualified to export products overseas or not.

Blue Cross Capital told BioWorld it does not engage in the export of medical masks.

This is an incident that may take place daily in China, as international buyers and Chinese companies and middlemen are desperate to trade during the COVID-19 outbreak.

“Some Chinese products are indeed not up to standard, but a bigger issue lies with the certification agencies, who issues documents to fool the Chinese companies to make them believe their products are qualified for export,” Xu said.

She added that even if a supplier has obtained such documents, it doesn’t mean its products are qualified. Quality products still need to go through proper inspection, manufacturing and registration.

Industry insiders have called on the government to clamp down on agencies that issue documents irresponsibly.

“Authoritative organizations should educate the med-tech companies and public about product registration and certification,” Xu said, adding that EU offices or chambers should also do so.

She also called on European authorities to inspect Chinese imports and said class I medical devices such as masks should be better regulated. Importers should also verify and inspect the Chinese test kits before reselling them to governments and laboratories, despite what the manufacturers claim.