Our COVID-19 Journey
Our COVID-19 Journey
Our COVID-19 Journey
China has been one of the world’s leading manufacturers of healthcare finished products and raw materials, but the world-wide demand for medical equipment and devices during the COVID-19 pandemic has increased exponentially. This surge in competition and commercial pressure has transformed the markets, where even the seasoned exporter/importer may struggle with radical changes in the global supply chain, together with sudden modifications in regulatory requirements for a successful exportation.
Before the pandemic, medical devices manufactured in China were exempted from filing or registration with the NMPA (Chinese equivalent to FDA) if they were used solely for export purposes and not distributed locally in China. Local Chinese manufacturers and exporters of medical devices were only required to validate that the exported goods met the quality requirements of the country of destination. However, as a result of incidents of faulty, low-quality or even counterfeit goods and in an effort to enhance the quality control of key medical devices for export during the COVID-19 outbreak, China has temporarily imposed additional regulatory requirements on five types of medical devices to be exported. These include COVID-19 test kits, surgical masks, surgical preventive clothing, ventilators and infrared thermometers, which are now either subject to NMPA registration as of April 2020 or otherwise requiring proper registration in the importing countries.
To add to the complexity, Chinese customs authorities will only grant clearance on exports of such medical devices if they can validate the corresponding NMPA registration certification submitted or otherwise can confirm the manufacturer of such medical devices are on a “White List” (which is updated often) maintained by the Ministry of Commerce. Additionally, in an effort to identify unqualified products for exportation, manufacturers of sub-optimal products are publicly posted on a “Black List” used by Chinese customs authorities that will refuse export clearance to goods from manufacturers on this “Black List”.
These tougher Chinese export controls in response to international pressure to weed out sub-standard equipment and devices , have created a huge backlog of exports at some of China’s busiest airport that have overwhelmed the global freight system, due to increased demand for PPE and a severe shortage of cargo planes. Following the worst ever congestion at Chinese airport facilities, Shanghai in particular, China introduced a new 28-hour gate in rule, in an effort to helped ease the issues. This meant that cargo cannot be received at airports more than 28 hours ahead of its scheduled booking time. While this measure helped reduce the cargo stored at airport facilities and large queues in trucks outside of terminals, it significantly shrank the window for the custom clearing process, resulting in a number of flights retuning empty to its destination.
During normal times, most cargo travels in the holds of passenger aircraft where the price is cross-subsidized, as passengers pay for most of the plane’s operating costs. As there are hardly any passenger flights at the present time, only the world’s small fleet of cargo aircraft are available causing the air cargo rates to have increased exponentially to over 500%! Currently, the only viable option for large emergency PPE order transactions is the use of cargo Charter planes. But even this option has turned difficult or tragic to unexperienced importers. In light of the extreme demand for emergency air cargo space, some fraudulent logistic companies would sell the same cargo plane to the highest bidder paying the highest price, causing extreme pain and financial loses to companies attempting to secure space in the limited number of charter cargo planes available.
Finally, beware of the route your charter cargo plane is expected to follow to reach the country of destination. Many reports during this global emergency accused certain territories to have confiscated partial or entire shipments under the premises that their country was experiencing an emergency shortage in PPEs. Other seizures were justified under the pretext of hoarding or that PPE supplies were counterfeits or of sub-standard quality, even if such shipment was only in transit through that jurisdiction.
XETLEY S.A. has been working tirelessly to get protective devices and critical care medications during the COVID 19 Pandemic to as many health workers and countries as possible. Our focus has been strictly on sourcing medical grade personal protective devices from reputable manufacturers in China. Our suppliers possess internationally approved Technical specifications to meet the minimum requirements to ensure good quality, safety, and efficacy for each product. We ensure our products meet General quality management system (ISO), proof of regulatory compliance (NMPA-USFDA-EU) approval when required, Free Sale Certificates (FSC), official test reports with corresponding laboratory accreditation and International Performance Standards (EN#, ASTM#, ANSI#, GB#).
XETLEY S.A. maintains qualified personnel in China to closely monitor the manufacturing process of each order and supervises the packaging and quality standards of each of our products. Because we understand the importance of the excellence of our PPEs for medical front line workers, we validate tests and quality of the raw materials and even the veracity of all accreditation of the certifying companies. We have learned, there should not be any aspects of the procuring process unattended to ensure a problem-free transaction. We closely monitor optimum ground logistics to the ideal exportation hub. We collaborate with local logistic companies with large storage facilities near airports that can meet rigorous SOPs for ensuring problem-free custom clearing process. We work directly with Air Cargo Charter companies in Europe and Asia in order to avoid unnecessary costs and efficient routes that can ensure timely deliveries.
XETLEY S.A. has conducted some of the largest exportation of PPEs in Latin America for individual countries and large non-profit organizations. We have been trusted with the supply of hundreds of metric tons of cargo using modern Boeing747-400 wide-fuselage, Boeing 777 cargo and smaller Airbus passenger A320 for smaller parcels.
While Governments, institutions, and communities around the world continue to grapple with the impact of COVID-19, we are honored to have a critical participation and key role during this Pandemic in helping source much needed PPEs in the Latin American region.
Our Team
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Changing lives one patient at time!