Early access opportunities for medtech innovation in China

For many multinational medtech companies, new technologies reach China later than major global markets. According to research on imported innovative medical devices launched in China, the average lag versus their U.S. launch was 4.4 years.  

Table 1. Comparison of global-to-China launch lag 

The gap is visible at launch, but its causes can arise well before regulatory submission. Depending on the product, companies may need substantial China-specific localization and validation before NMPA submission. This includes finalizing the local product configuration, securing samples for testing, adapting digital functionality, and establishing local cloud and data arrangements. Following this, companies need to prepare the NMPA submission package. This requires confirming device classification, assessing the adequacy of overseas clinical evidence, and preparing documentation such as the instructions for use, product testing reports, and other supporting materials.  

 The delays can be costly. Domestic medtech companies continue to strengthen their innovation capabilities, while product cycles are becoming shorter in many categories. A differentiated global launch may face a much more competitive market by the time it reaches China. Meanwhile, China continues to expand and refine pathways for innovative medical products, from national regulatory reforms to regional early-access programs. Simon-Kucher’s previous China medtech research has highlighted the increasing relevance of these pathways alongside broader market-access reform.  

The question for global medtech leaders is therefore becoming broader than “How can we accelerate NMPA approval?” Now, they must answer, “How can we prepare China earlier, and which access mechanisms can help create value before nationwide launch?” 

Early access is becoming a meaningful part of the China launch toolkit 

China now has several mechanisms through which selected overseas medical devices can reach patients before nationwide registration, although their maturity and eligibility requirements differ significantly. 

Bo’ao Lecheng has developed one of the most established frameworks. Clinically urgently needed products approved overseas can be introduced through qualified medical institutions, subject to local assessment and approval. Importantly for medical-device companies, the framework has also evolved beyond in-hospital use. To date, over 330 medical devices have landed in Bo’ao. Since 2023, eligible monitoring, rehabilitation, and home-treatment devices can be taken out of the hospital under a regulated take-home pathway.  

The Greater Bay Area’s “Hong Kong and Macao Medicine and Equipment Connect” follows a different model. Eligible devices must be clinically urgently needed, have been procured and used by Hong Kong or Macao public hospitals, and demonstrate clinical application advancement. The mechanism has moved well beyond its initial pilot phase. As of mid-2026, 71 designated medical institutions were participating, and 95 medical-device products had been approved for introduction under the program.  

A broader national route has also begun to take shape. In 2024, the NMPA and National Health Commission issued national requirements allowing qualified medical institutions to apply for temporary import and use of certain overseas-marketed, clinically urgently needed medical devices. Beijing subsequently introduced a local implementation framework, establishing a clinical-demand-led green channel supported by joint assessment, streamlined evaluation for repeat imports, and customs facilitation. Shanghai introduced a similar framework in 2025. These should not yet be viewed as equivalent in maturity to Bo’ao or GBA, but they reinforce a broader direction of travel. Controlled earlier access to overseas innovation is becoming a more established feature of China’s regulatory landscape.  

For medtech companies, however, the important point is not simply that more pathways exist. The pathways have distinct tradeoffs and different strategic implications. Bo’ao starts from overseas approval and offers a relatively developed environment for special access and real-world evidence. GBA creates a potential bridge from Hong Kong or Macao into mainland China but requires a stronger prior-use basis. Beijing and Shanghai remain more case-specific. Pathway selection therefore needs to be considered alongside global launch sequencing, clinical evidence, product configuration, and the intended care model. 

Table 2. Comparison of pathways 

Early access is broader than “first-in-class”  

It is easy to assume that early access is relevant only for breakthrough technologies addressing severe diseases with no available treatment. The actual policy language and implementation experience are more nuanced. 

A completely new treatment modality with a clear unmet need will naturally make a strong case. But early-access products do not necessarily need to be first-in-class. The more relevant question is whether a device provides a sufficiently compelling clinical improvement for a defined patient population or use case. This creates an important distinction for next-generation products. An incremental feature upgrade is unlikely to be persuasive by itself. Manufacturers need to translate technical differentiation into a clinical argument: Which patients are still poorly served by existing options? Does the device materially improve efficacy, safety, adherence, usability, or clinical workflow? Is that difference meaningful compared with products already available in China? 

For example, Cochlear’s CI632 entered an already highly competitive cochlear-implant category in China, with multiple domestic and international suppliers active in the market. At Zhongshan First Hospital, clinicians identified a specific need among patients requiring continued MRI follow-up and highlighted CI632’s 3.0T MRI compatibility with the implant magnet in place, alongside its finer and more flexible electrode design. The application highlighting this differentiation was approved in just over one month in 2023. Before official launch, CI632 gained strong traction through GBA early access, with 310 pediatric patients at Qianhai Shekou Hospital alone receiving the treatment by December 2024.  

Real-world evidence works best when it closes a gap 

Real-world evidence (RWE) is another increasingly relevant part of the toolkit, particularly in Bo’ao. China issued its first technical guidance on the use of real-world data in medical-device clinical evaluation in 2020, followed by more detailed guidance on study design and statistical analysis in 2024. That guidance is also clear about the current role of RWE: at this stage, it is primarily used to supplement existing clinical evidence, rather than automatically replacing conventional evidence generation.  

Lecheng has since developed a more specific route linking special access with registration. Its 2026 guidance sets out how RWE generated from clinically urgently needed imported drugs and devices can be used to support China registration applications, including the need to first assess existing overseas evidence and define what additional question the local evidence should answer.  

For manufacturers, this suggests a more disciplined way to think about RWE. The starting point should not be “Can we generate China RWE?”, but “What evidence gap do we actually need to close?” If robust overseas evidence already answers the relevant regulatory question, duplicating an efficacy study in China may add limited value. In other situations, local evidence may help address uncertainty around Chinese patient characteristics, longer-term outcomes, actual use, adherence, or a new clinical workflow. 

A recent example is Roche Diagnostics’ Elecsys Alzheimer’s disease CSF assay series. RWE generated in Hainan was used to support NMPA approval through the priority review pathway. After entering clinical use in Bo’ao and initiating RWE generation in September 2024, the assays obtained NMPA approval in December 2025, within approximately 15 months. The China RWE addressed a specific evidence gap to validate and to establish appropriate cutoffs for the Chinese population. 

The value can also extend beyond the registration dossier. Early-use data can help physicians gain experience with an unfamiliar technology, clarify which patient segments benefit most, refine medical education, and test how a new device fits into Chinese clinical practice. These are strategic and medical uses rather than formal regulatory functions, but they can materially improve readiness for a later nationwide launch. 

ZEISS VISUMAX 800, a femtosecond laser system for refractive surgery, provides another example. Through early use in Bo’ao before national approval, VISUMAX 800 was used in more than 270 procedures, providing Chinese ophthalmologists with early hands-on experience with the technology and generating practical insights from patient follow-up and clinical outcomes. This early experience strengthened clinical readiness for broader adoption ahead of nationwide launch. 

Build early access into China launch planning 

The broader lesson is that companies should not wait until after an overseas launch to ask whether Bo’ao, GBA, or another pathway might be available. Many of the factors determining whether early access creates value are decided much earlier. 

For example, GBA attractiveness can depend on whether and how a product is launched and used in Hong Kong or Macao. Bo’ao feasibility may depend on whether the clinical differentiation can be substantiated. For connected products, the version available for early access may also depend on decisions around connectivity, cloud architecture, and data management. Evidence generation is similarly easier to shape before global clinical and medical plans are finalized than after them. 

Early access can therefore strengthen China launch readiness. A credible early-access strategy requires product, regulatory, medical, government affairs, digital, and commercial teams to answer a common set of questions earlier: What exactly are we bringing to China? For which patients? With what evidence? Through which access route? Under what operating model? And what strategic value do we expect to create before a nationwide launch? 

In an increasingly competitive market, companies that plan for early access sooner will be better positioned to bring innovation into China faster and capture more of its value once it arrives. 

Thanks to contributions from Ruoyu Jiang, Keshi Li and Lotus Yuan!