COVID-19: How Safe is Protective Equipment Made in China?

The COVID-19 pandemic has led to a worldwide surge in demand for medical devices and personal protective equipment (PPE), including in Germany and Europe. In order to ensure adequate supply, the EU Commission and member states are taking measures at various levels. This includes temporarily adjusting regulatory requirements to make urgently required products available more easily. Under certain conditions, products can therefore be brought into the market if they comply with technical regulations in other markets that offer an equivalent level of protection as EU standards. Since March 2020, some EU-member states have had negative experiences when importing medical devices and PPE from third countries. In several cases, products coming from China – the world’s largest producer of PPE – were found to not meet the stipulated requirements. Additionally, there is an increasing number of fake certificates in circulation. Without relevant experience, market surveillance authorities face challenges when evaluating the authenticity of conformity declarations for imported products, that are based on regulations of other jurisdictions.

On behalf of German Federal Ministry of Economic Affairs and Energy (BMWi), GPQI has therefore set up a direct channel with responsible Chinese authorities to provide assistance to German market surveillance authorities in the following ways:

Assessment guidelines: In consultation with relevant Chinese authorities, GPQI has developed a guideline for the assessment of Chinese certificates of conformity. The guide can be used as an orientation for German market surveillance authorities.

Exchange mechanism for case-by-case verification: GPQI supports German market surveillance authorities by offering a mechanism to verify the authenticity of Chinese test reports and certificates for masks. For this purpose, GPQI has established a direct exchange channel with the respective Chinese authorities.

Support and use of Chinese market surveillance activities: In cooperation with Chinese political partners, the project supports Chinese market surveillance measures and promotes the exchange of experiences to assist the work of German authorities and decision-makers, e.g. regarding

• Nation-wide special inspections of Chinese mask manufacturers (February 2020)
• Comparison of Chinese and European norms and standards for medical devices and PPE (March 2020)
• Stricter control for exports of medical products and PPE (April 2020)
• Special surveillance initiatives against fake certificates and fraudulent certification activities for medical products and PPE (April 2020)

Access the factsheet on GPQI’s support for ensuring product quality and safety of masks from China.