“Made in China 2025” and Gaining Chinese Market Access for Swiss MedTech Stakeholders
“Made in China 2025” constitutes a pivotal strategic national plan and industrial policy of the Chinese Communist Party, spearheaded by President Xi Jinping within the framework of the 13th and 14th five-year plans. This initiative focuses on consolidating China’s journey from a labor-intense to a tech-savvy society, boosted by pioneer technological innovations.
Formulated to secure independence from foreign suppliers, the initiative aims to expand China’s portfolio by increasing the production of high-tech products and ancillary services. Since 2018, the term “Made in China 2025” has faced negative responses from the USA, Europe, and other countries. Consequently, Chinese authorities have deliberately downplayed the term in official communications. Despite being less prevalent, the national program persists and continues along its strategic roadmap.
China continues substantially investing in innovative technologies, with key sectors encompassing:
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However, advanced industry standards are vital to promote innovation and address obstacles in such industrial development. Adherence to high-level standards is essential for facilitating progress and overcoming challenges in industrial growth. The increase of China's middle class, urbanization, and an aging population collectively propel a surge in demand for higher quality goods and services, marking what is referred to as the "quality revolution.” This revolution is centered around entrepreneurship and craftsmanship, fostering a culture of continuous improvement and refinement in the quality of produced goods.
China's increasing demand for high-quality goods and services has also impacted the medical technology sector. To address this need and remain competitive in the future, the “Made in China 2025” initiative emphasizes the need to keep the cost of MedTech products low. Thus, investments in local production of advanced medical devices are favored to avoid solely relying on the international imports of such valuable goods.
In the meantime, China's growing middle class continues to demand higher-quality goods and services. This trend has boosted the Chinese MedTech market to become the second-largest globally. Hence, the Chinese market presents immense opportunities for top-quality vested international companies, particularly the Swiss and European MedTech organizations. However, the Chinese market is difficult to access due to its regulatory burden.
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To increase your chances and mitigate the risks associated with entering the Chinese MedTech?market (China Association for Medical Devices Industry, CADMI), engagement with qualified and experienced partners adept at navigating the complex registration process is crucial. Professional partners support you in overcoming the most common challenges leading to delays in your registration processes, including detecting and filling gaps in technical files, translation difficulties, linguistic barriers, additional testing requirements, product change management, limited resources, lack of dedicated project teams; knowledge-gaps in understanding legislation; and poor time management.
"Contact JAKSCH LIFESCIENCE CONSULTING GmbH to discuss possible risk mitigations to guarantee smooth access to the Chinese market".
Driven by factors such as an aging population, rising disease burden, and increasing demand for modern medical treatment, entering the Chinese market is an excellent opportunity for international MedTech stakeholders. Integration of a global product marketing strategy early in the design and development process is highly recommended, and a comprehensive gap assessment is essential to avoid pitfalls during the registration process in China.
Selecting diligent and experienced consultants capable of supporting design and development, regulatory affairs, and clinical teams is paramount. In this context, JAKSCH LIFESCIENCE CONSULTING GmbH is positioned to enhance registration success and expedite entry into the Chinese market. If you want to exploit this opportunity and gain access to the Chinese MedTech market, contact JAKSCH LIFESCIENCE CONSULTING GmbH and learn how our expertise can support your various teams in regulatory affairs, quality management, cleaning, packaging, sterilization, reprocessing, biocompatibility, and toxicology.
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