Ban on export of domestically unregistered medical products to impact manufacturers

In response to a large number of defective medical supplies exported from China to Europe, China has issued new regulations which allow the export of only domestically-registered supplies.

Photo: Tuchong

Photo: Tuchong

By XIE Xin


After multiple reports of sub-standard medical supplies being received in Europe, industry insiders Jiemian News spoke to grew concerned about the longterm implications for the export business of anti-coronavirus products.

Now, the government is responding.

On March 31, the Ministry of Commerce, the General Administration of Customs, and the National Medical Products Administration (NMPA) jointly published the Announcement on Proper Export of Medical Supplies, in an effort to enhance the management of anti-virus exports.

The announcement requires that starting April 1st, exporters shall provide Chinese Customs with statements demonstrating that the products meet requirements under Chinese law as well as the laws of the purchasing country, for any test kits, medical masks and protective suits, ventilators and infrared thermometers to be exported. The move aims to effectively support the global fight against the virus by providing quality, safe products and ensuring well-organized exporting practices. These medical product regulations are subject to adjustment based on the evolution of the pandemic.

The new regulation comes after some Chinese-produced medical products were identified as unqualified in Europe and returned. Product in question included test kits exported to Spain by Shenzhen Bioeasy Biotech Company and masks exported to the Netherlands.

Relevant medical devices like test kits and masks exported to the European Union appear to be at the epicenter of quality problems.

The European Union takes a "broad access and heavy penalty" strategy to certify imported invitro diagnostic reagents and masks as “CE” which means they meet the health and safety requirements for the EU. The EU process emphasizes corporate integrity and entrusts third-party certification, but it is loose enough that some CE certificates have been reportedly available for purchase without inspection — on ecommerce sites like Taobao.

In addition, EU regulations do not require that imported medical devices such as test kits and masks to receive registrations in China as a precondition. 

For medical devices, China Food and Drug Administration (CFDA) has regulations on certification for exported medical devices (No.18, 2015), in which the second provision states that "Departments of CFDA may issue Certification for Exported Medical Devices to corporations that have already completed registration and obtained production permits, or have submitted relevant filings for the production of medical devices."

Nonetheless, the Certification for Exported Medical Devices is not compulsory for exports. Instead it's intended to "further standardize CFDA's handling of the service matter of issuing certifications for medical devices' export and facilitate the export business of relevant companies".

The foremost requirement in the new regulation is that Chinese exporting companies verify that all required registrations and certificates for medical devices has been issued and that Chinese customs has inspected and released the items after review of that relevant paperwork authorized by the National Medical Products Administration.

These measures have disqualified many medical manufacturers from exporting, even after orders are already placed. 

According to published documents, medical products successfully registered in National Medical Products Administration (NMPA) include 23 detection products for coronavirus, 42 ventilators, 301 medical protective clothing, 150 medical protective masks, 523 medical surgical masks, 753 disposable medical masks and 236 infrared thermometers. Taking the test kits as an example, types of products being exported far outnumber those registered in China.

As reported by 21st Century Business Herald, some exporting companies have expressed dissatisfaction towards this regulation and are about to appeal to the Ministry of Commerce. In addition, some test kit manufacturers, such as Xilong Scientific Company and Sinocare Incorporation, indicated that they will adjust their sales strategy or speed up domestic registration.

If this regulation lasts, the first option would undoubtedly be to seek domestic registration for any intended continuous exporting. Since the NMPA opened the emergency approval channel two months ago, there have been more than 20 test kits products reviewed and approved. These days, it may take quite a while for candidate products to be approved as the review & approval office is swamped with new applications.

Another option is to cooperate with manufacturers that have already received the required registrations. Jiemian reporters have determined that as early as late January and early February, manufacturers with registration and those without registration began partnering together to expand exporting capacity for urgent-needed test kits.