Recently, the Medical Device Supply Chain Branch of the China Federation of Logistics and Purchasing held a certification ceremony to honor companies selected for the Industry Standard for IVD Reagents Cold Chain Logistics Services. Following a comprehensive evaluation by the National Logistics Standardization Technical Committee, HTDK was recognized as part of the third batch of pilot enterprises for this industry standard. This recognition signifies the high-quality, end-to-end cold chain services provided by HTDK, which has been acknowledged by leading industry authorities.

In recent years, the rapid growth in downstream demand has created a favorable environment for the domestic In Vitro Diagnostics (IVD) market. Driven by factors such as healthcare reforms, an aging population, increased insurance coverage and spending, as well as advances in modern diagnostic and biotechnology, the IVD market in China has seen impressive growth. According to statistics, the market size expanded from RMB 45 billion in 2016 to RMB 124.3 billion in 2021, with its share of the medical device market increasing from 12.2% in 2016 to 15.1% by 2019. This trend is expected to continue, with the IVD market projected to reach RMB 200 billion by 2024.

Simultaneously, the IVD industry is advancing its third-party medical device logistics efforts in line with policy improvements, promoting the storage and transport of IVD reagents. These initiatives aim to lower logistics costs, increase the concentration of distribution channels, and strengthen product traceability, which is critical for managing high-risk IVD reagents. These developments are expected to significantly contribute to the industry’s standardization and efficient management.

The Industry Standard for IVD Reagents Cold Chain Logistics Services was developed in response to these trends. Officially implemented on July 1, 2021, this standard outlines the basic requirements for cold chain logistics services, including personnel training, equipment, logistics operations, temperature monitoring and control, traceability, and emergency response.

Since 1996, when HTDK established its base in the Waigaoqiao Free Trade Zone in Shanghai, the company has developed extensive experience and leadership in the import/export, cold chain storage, and transportation of IVD products, making it one of the few platforms in China capable of offering end-to-end commercial solutions.

“In 2019, HTDK partnered with a global leader in gene sequencing to establish a dedicated logistics center in the Waigaoqiao Free Trade Zone. We provided facilities for freezing (-15 to -25°C), refrigeration (2 to 8°C), and temperature-controlled storage (15 to 25°C), while also managing product import, storage, and distribution,” said Elsa Lee, General Manager of HTDK’s New Supply Chain Value-Added Services Division. “Since the outbreak of COVID-19, HTDK has worked closely with our partner to ensure rapid delivery of sequencing products to disease control centers in Wuhan, Beijing, and Yunnan Province. In April 2021, we upgraded our cold chain packaging to extend insulation time, increase load capacity, reduce costs, and improve outbound efficiency. By July 2021, we began operating two hubs in northern and southern China to meet emergency delivery needs, and HTDK is now our partner’s primary warehousing solutions provider in China.”

HTDK’s Asia-Pacific Biopharmaceutical Distribution Center, established in 2019 in the Waigaoqiao Port Free Trade Zone, features 6,000 square meters of medical device storage and 1,200 square meters of hazardous materials storage, making it the only platform in the zone capable of handling hazardous cold chain exports. The center provides full-chain temperature-controlled solutions to ensure the safe handling of products. From this center, HTDK manages the storage of its partners’ medical devices based on their specific temperature requirements, and processes orders for shipment to 14 countries and regions across the Asia-Pacific.

“We are honored to collaborate with the industry to set a high standard for IVD cold chain logistics services and contribute to the healthy development of the sector,” Elsa added. “In the future, HTDK will continue to focus on providing end-to-end professional commercial solutions for high-value medical devices, driving innovation, and striving for excellence to serve our partners at the highest industry standards.”