MT Bridge

As global medical technology rapidly evolves, “How to enter a target market” has become a key strategic question for companies. For international medtech firms, both China and the UK offer attractive opportunities—but with very different barriers to entry. This blog offers a side-by-side comparison of the two countries’ market access systems and challenges, providing a clear reference point for companies navigating these complex landscapes.

🇨🇳 China: Clearer Regulations and Full UDI Implementation

The National Medical Products Administration (NMPA) is China’s top regulatory body for medical devices, pharmaceuticals, and cosmetics. All imported medical devices must be registered with the NMPA before entering the Chinese market.

Since 2021, China has gradually rolled out the Unique Device Identification (UDI) system for medical devices. This initiative improves traceability and quality control, and it has now been extended to many high-risk devices. UDI is becoming a fundamental component of regulatory compliance in China.

Currently, the core regulatory framework is based on the “Regulations on the Supervision and Administration of Medical Devices,” which came into effect on 1 June 2021. In parallel, the NMPA continues to strengthen regulatory enforcement through periodic quality inspections on selected devices.

⚠️While China’s regulatory environment is increasingly comprehensive, it also presents notable challenges for foreign businesses. These include high entry barriers, long registration timelines, strict requirements for documentation in Chinese, and the mandatory use of local agents. Additionally, policy preferences often favor domestic manufacturers. For many small and medium-sized foreign firms, these factors can become significant hurdles to market entry.

🇬🇧 United Kingdom: Regulatory Transition and UDI Still Pending

Brexit has led to major changes in the UK’s medical device regulatory system. The UK no longer follows the European Union’s MDR (Medical Device Regulation), and instead has introduced its own UKCA (UK Conformity Assessed) certification scheme. However, the UK is still in a transitional phase, during which CE-marked products, including those compliant with MDR, are temporarily allowed in the market.

According to current MHRA policy:

• General medical devices (including active implantables) compliant with the old MDD directive may be placed on the UK market until 30 June 2028 or the expiry date of the certificate, whichever comes first.
• In vitro diagnostic devices (IVDs) and general medical devices compliant with MDR (including custom-made devices) may remain on the market until 30 June 2030 or the certificate expiry date.

These staggered deadlines underscore the transitional and somewhat fragmented nature of the UK’s regulatory environment.

Although the UK aims to establish an independent regulatory system, it has yet to enforce a national UDI system. In contrast to countries like China and the United States, this delay has raised concerns over whether the UK is keeping pace with international best practices. The FDA (2021) has already highlighted the UDI system’s benefits in enhancing traceability and reducing medical errors. The lack of such mechanisms in the UK places it at odds with global regulatory trends.

As noted by Moore and Kutlu (2023), some international manufacturers perceive the UK market as relatively small and unnecessarily complex, representing only 3 percent of the global MedTech market. For these reasons, certain companies may opt to prioritize entry into larger and more stable markets such as the EU or the United States.

🤔Despite these issues, the UK retains significant appeal. The UK government has demonstrated strong support for digital health and AI-based medical technologies. The digital health ecosystem is active and competitive, creating a dynamic environment for innovation. Additionally, various funding programmes offer financial and logistical support for bringing innovative products into the NHS system. These resources can be especially beneficial for smaller firms with strong R&D capabilities but limited market access.

The UK’s research infrastructure and close ties between academia and industry provide further incentives. For companies with long-term goals and the capacity to navigate regulatory uncertainty, the UK remains a viable and potentially rewarding market.

To be continued….

This post provides a preliminary look at the challenges and opportunities related to market access in China and the UK. In our next blog, we will explore how these differences can be bridged through trade collaboration and what makes cross-market engagement possible despite regulatory divergence.