China is often not among the top three markets on most manufacturers’ market access priority lists.

It's widely perceived as a difficult market to penetrate, with a complex regulatory landscape and challenging registration processes.

As a result, many manufacturers tend to prioritize larger, more familiar markets, such as the EU and the U.S., after launching in their home country.

But things are shifting…

The time-to-market in the EU has significantly lengthened since the EU MDR came into effect. This holds especially true for Class Is and Class IIa and above.

Your conformity assessment timeline depends entirely on the availability and workload of Notified Bodies.

With no official review deadlines in place, it’s become nearly impossible to estimate how long the process will take.

Currently, certification for a new device in the EU can take anywhere from 9 to 24 months. It is often even longer for higher-risk devices.

Transitioning from MDD to MDR alone can take 2-3 years for many companies.

Sounds familiar? China’s approval timeline now closely mirrors that of the EU.

Is it time to rethink your strategy?

Let’s talk numbers:

• China: 1.4 billion people

• European Union: ~450 million people

• United States: ~340 million people

China offers 3-4 times more market reach compared to the EU or U.S. Despite the competition, the opportunity is distinct.

Wondering what the future holds for your device in China? Let’s dive in.

🍜New NMPA Announcement

China has been actively restructuring its policies to boost global competitiveness.

Among the most notable initiatives are “Buy China” and “Made in China 2025”. Both have drawn criticism from the European Commission.

This month, the NMPA unveiled a new policy direction focused on advancing high-end medical devices.

What falls under High-End Medical Devices?

• Medical robots

• Medical imaging systems

• AI-powered medical devices

• Devices made with novel biomaterials

These products must leverage cutting-edge technologies and demonstrate significant clinical value.

China is prioritizing developments in artificial intelligence, robotics, and regenerative biomaterials.

If your product falls into one of these categories and China is on your radar, now is the time to align your pipeline and get your ducks in a row for market entry.

👉 Check out Part 1 for an overview of NMPA’s broader goals for the medical device industry.

🍜NMPA’s Key Initiatives

Accelerated approval pathway

Devices that are first-in-China, globally leading, and demonstrate clinical value will qualify for the Special Review Procedures.

Strengthening Expert Support & Communication

NMPA will establish expert panels and improve communication channels for testing, clinical evaluation, and documentation guidance.

Clarification on product category

Efforts are underway to clearly define the classification and naming of high-end equipment, including assigning risk categories and forming dedicated R&D core groups.

Development of new standards

New standards are being developed for emerging technologies. This particularly focuses on areas like exoskeleton robots, radionuclide imaging systems, etc.

Regulatory clarity

NMPA will release detailed review guidelines for products like: laparoscopic surgical systems, MRI systems, oral bone graft materials, nickel-titanium vascular implants.

The agency also plans to clarify registration amendment procedures, performance requirements for AI-powered devices, and explore the use of eIFUs.

Post-market surveillance

Given their high-risk nature, high-end devices will be subject to stricter PMS controls. This includes:

• Service life validation

• Routine maintenance enforcement

• Expanded definitions for reportable adverse events

• Guidance on reporting

• Stronger emphasis on proactive reporting

Boosting Regulatory Science & Industry Insight

Dedicated working groups will track technological trends and research on high-end devices.

The goal is to promote real-world evidence (RWE) in regulatory decision-making.

Increasing global engagement

China is collaborating with IMDRF, GHWP, and Belt & Road partners to shape international standards.

NMPA also encourages manufacturers to expand globally and is developing export certification policies for high-end products.

Does your product qualify as high-end? Schedule a complimentary strategy session via the link.

PS: I'm currently available to take on one new consulting project. Let’s connect if you're exploring market entry into China or need support navigating NMPA regulatory requirements.

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Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. Neither I nor my employer is liable for any use of this content. This newsletter does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.