This year marks the 10th anniversary of the proposal for jointly building the "Belt and Road" initiative. From 2013 to 2022, the cumulative scale of goods trade between China and the countries involved in the initiative reached 19.1 trillion US dollars, with an average annual growth rate of 6.4%. The economic and trade cooperation under the "Belt and Road" initiative has continued to deepen. Against this background, the trade of medical devices between China and the countries along the "Belt and Road" has become more frequent, and the trade volume has significantly increased. Entering the markets of the countries along the "Belt and Road" has become a preferred option for medical device companies.

According to statistics, when the "Belt and Road" initiative was proposed in 2013, there were 65 countries involved, including China, with a total population of about 4.4 billion and a gross domestic product of about 21 trillion US dollars, accounting for 62.5% and 28.6% of the global total, respectively. The countries along the "Belt and Road" initiative cover most of the Asian countries, nearly half of the European countries, and one African country, Egypt. The countries along the "Belt and Road" have vast markets and diverse consumer demands. With the substantial improvement of transportation infrastructure in recent years and the enhancement of commodity logistics efficiency, it has created favorable conditions for the export of medical devices.

Rapid growth in China's import and export of medical devices to and from countries along the "Belt and Road"

In recent years, the overall proportion of China's medical device products in the trade with countries along the "Belt and Road" has been increasing year by year, showing a rapid growth trend. Currently, the countries along the "Belt and Road" have become important markets for China's medical device products.

From 2019 to 2022, the import and export volume of medical devices between China and the countries along the "Belt and Road" has rapidly increased from 93.938 billion yuan to 241.594 billion yuan, with an average annual compound growth rate of 37.01% (see chart). With China's continued deepening of the joint construction of the "Belt and Road" initiative, the countries along the "Belt and Road" will play an increasingly important role in China's medical device trade in the future.

Challenges facing China's entry into the markets of the countries along the "Belt and Road" with medical devices

Medical devices are special products that are strictly regulated and examined globally. For Chinese medical device products to enter the markets of the countries along the "Belt and Road," relevant enterprises must understand the medical device regulatory system, social culture, and healthcare policies of the target countries. The countries along the "Belt and Road" have a long history and diverse traditional cultures, and it is necessary to continuously coordinate and integrate during the process of communication to form a basis of mutual understanding and trust, thereby promoting deep economic cooperation.

The first challenge facing the entry of medical device products into overseas markets is how to meet the medical device regulatory requirements of the target markets. There are numerous countries along the "Belt and Road," with significant differences in national conditions. Some countries have joined regional economic alliance organizations, with common regulatory requirements, while others have their own regulations. Some countries recognize CE certification from the European Union or certification from the U.S. Food and Drug Administration, rather than having their own regulatory regulations.

The registration and approval procedures for medical devices may also differ in different countries, with some being very cumbersome, including the submission of detailed documents, conducting clinical trials, and waiting for government approval, which prolong the time for products to enter the target markets. In addition, the requirements of medical device regulatory authorities in various countries for standard specifications, product registration, and quality management systems also vary.

Language barriers and cultural differences can also pose challenges for the access of medical devices, potentially leading to misunderstandings or communication issues, and requiring the use of correct labeling and document translation.

Understanding the medical device regulatory requirements of international regional cooperation organizations

To promote economic and trade exchanges, most countries along the "Belt and Road" have joined international cooperation organizations in their respective regions to enhance regional integration and promote exchanges and cooperation. These organizations include the Shanghai Cooperation Organization, ASEAN, the European Union, the Eurasian Economic Union, the South Asian Association for Regional Cooperation, and the Gulf Cooperation Council (see table 2). In terms of medical device regulation, some regional cooperation organizations have formulated detailed regulations or directives, unifying regional access requirements, such as the European Union and ASEAN.