Pharmaceutical News, November 26: The National Medical Products Administration has released a draft of the “Technical Guidance Principles for Clinical Evaluation of Medical Devices,” which has attracted widespread attention and opened a new pathway for bringing new products to market in China. The guidance officially came into effect in June 2015. Clinical Evaluation or Clinical Trials? Currently, the process for launching new medical devices in China is fairly well-defined: Class I devices require only filing, while most Class III devices mandate clinical trials—particularly those listed in the “Catalogue of Class III Medical Devices Requiring Clinical Trial Approval.” For Class II devices, as well as certain Class III devices, manufacturers face a choice between clinical evaluation and clinical trials. Most companies prefer clinical evaluation over clinical trials. Cost is a major factor: clinical trials are extremely expensive, with uncertain outcomes, making them a high-risk investment. While a clinical evaluation report (CER) is not inexpensive—typically priced around RMB 200,000–300,000 by contract research organizations (CROs)—it remains far less costly than conducting full-scale clinical trials. Another significant advantage is time savings. Including preparatory and initiation phases, completing a clinical trial often takes two to three years—a lengthy timeline. In contrast, a CER can usually be finalized within three to four months, shortening the time-to-market by at least one to two years. Given the rapid pace of innovation and short product lifecycles in the medical device industry, this reduction in time is highly valuable for manufacturers. For these reasons, many companies place great hopes on clinical evaluation, driving up pricing for such services. However, a careful reading of the “Technical Guidance Principles for Clinical Evaluation of Medical Devices,” combined with an analysis of the current situation at the Center for Medical Device Evaluation (CMDE), reveals that the regulatory authorities did not issue these guidelines primarily to create a fast-track route for mass-market entry of new products. Instead, the aim is “to differentiate among various clinical evaluation scenarios, appropriately set corresponding requirements, enhance the relevance and scientific rigor of clinical evaluations, and reduce the administrative burden on stakeholders.” Challenges in Using CERs for Market Entry For low-risk devices with stable manufacturing processes, minimal design changes, and substantial prior safety and efficacy data, requiring manufacturers to conduct another clinical trial is both wasteful of resources and time. A CER offers an alternative approach, leveraging existing data to assess product safety and effectiveness. Nevertheless, for innovative or higher-risk devices, achieving market approval via CER remains challenging. First, finding suitable comparator products is difficult. Ideally, the comparison should involve a product similar to the one under review that has already been approved domestically. Such options are rare, especially for devices featuring technological innovations. Additionally, there’s an implicit requirement: the comparator should ideally be the manufacturer’s own previous-generation product. This preference stems largely from production‑process comparisons; without access to proprietary manufacturing information, obtaining relevant technical details becomes nearly impossible. Currently, the CMDE mandates proof of legitimate data sources. In Article 6 of the “Notice of the State Food and Drug Administration on Issues Related to the Implementation of the Regulations on Registration Management of Medical Devices and In Vitro Diagnostic Reagents” issued on November 4, 2015, it is emphasized that “when conducting clinical evaluations pursuant to Article 6 of the Technical Guidance Principles for Clinical Evaluation of Medical Devices, if the applicant uses production processes, clinical data, or other materials from the same type of medical device, they must submit authorization documents confirming the use of such materials.” This measure effectively prevents unauthorized acquisition of third-party data. Second, securing sufficient clinical literature poses another challenge. For truly innovative products, the CER route is particularly difficult due to the lack of prior studies and data. Out of caution, the CMDE may hesitate to approve innovative products through CER. Domestically produced devices typically have limited international data, while imported products that entered the market without clinical trials abroad—and whose overseas presence is relatively brief—often lack robust clinical evidence. Therefore, products that meet the following criteria are more likely to succeed via CER: long market history (providing ample clinical literature), stable manufacturing processes (with little or no significant change compared to previous versions), and low risk levels. Third, inconsistencies in clinical study results and insufficient evidence strength further complicate matters. Even when abundant clinical literature exists, quantitative analyses required by the CER necessitate meta-analysis. If the conclusions drawn from these studies remain divergent, adequate clinical evidence may still elude researchers. During a recent CER training session, someone asked how many clinical papers would be needed. The instructor replied that the final decision hinges on the strength of the evidence: if the studies are highly persuasive and reach consistent conclusions, just a few papers might suffice; conversely, if the evidence is weak—such as case reports involving only a handful of cases with conflicting findings—even hundreds of papers may fail to provide the necessary support for regulatory approval. Fourth, obtaining reliable Chinese-subgroup data presents additional hurdles. The CER requires inclusion of Chinese-specific data subsets, which can be particularly problematic for imported products. On one hand, clinical trials conducted in Europe and the U.S. often include very few Chinese or Asian participants, with Caucasian subjects predominating. On the other hand, some studies deliberately avoid collecting detailed ethnic data, making it difficult to extract Chinese or Asian subpopulation information from the results. Without such data, the CMDE may demand a small-scale clinical trial solely to confirm the absence of ethnic disparities. Yet even a modest trial entails considerable time and expense. If the outcome of the CER ultimately leads to a clinical trial rather than market approval, all prior efforts could prove futile. Moreover, for highly innovative products carrying certain risks, even after assembling sufficient data and clinical literature to prepare a CER, the CMDE may still request additional evidence to ensure product safety. Which Products Are Suitable for CER? To date, numerous companies have submitted CERs to the CMDE. Some have been rejected, others requested supplementary data, while a few have received approval. Based on the requirements outlined in the guidance and feedback from the CMDE, products best suited for the CER pathway generally exhibit the following characteristics: 1. Imported products transitioning to domestic production; 2. Long-standing market presence, preferably from the same manufacturer; 3. Stable manufacturing processes with no major modifications; 4. Low risk profile. The “Technical Guidance Principles for Clinical Evaluation of Medical Devices” have indeed opened a new avenue for medical device registration in China, saving manufacturers time and costs while avoiding redundant duplication of existing data. This represents a positive step forward for regulators, manufacturers, and patients alike. Further interpretation of these guidelines and concerted efforts across all stakeholders will be essential to accelerate the market introduction of medical devices through the CER pathway.

[Global Healthcare Resources] China’s “13th Five-Year Plan for the Development of the Pharmaceutical Industry and Healthcare” has been basically completed and has entered the stage of soliciting public opinions. Among its priorities, medical informatics, high-performance medical devices, and biopharmaceuticals will be key areas of development. These three sub-sectors will also receive prioritized national support during the 13th Five-Year Plan period, highlighting significant investment opportunities. On March 30 this year, the General Office of the State Council issued the “National Plan for the Development of the Medical and Healthcare Service System (2015–2020),” which stated that over the next five years, China will launch the “Healthy China Cloud Services” initiative. By actively leveraging new technologies such as mobile internet, the Internet of Things, cloud computing, and wearable devices, the plan aims to promote health information services and smart healthcare solutions accessible to all citizens, advance the application of big data in health care, gradually transform service delivery models, and enhance both service capacity and management standards. At the 2014 China Health Conference, Zhang Feng, Deputy Director-General of the Planning and Information Department of the National Health and Family Planning Commission, emphasized that during the 13th Five-Year Plan period, the healthcare sector will be a central focus of national informatization efforts and has already been incorporated into the country’s key plans for cybersecurity and information technology development. The “Internet Plus Healthcare” model is poised to bring transformative changes and new opportunities across the entire health industry. According to statistics, in 2014 global venture capital investment in the internet-based healthcare sector exceeded US$4.1 billion—up 124% from 2013—and involved a total of 258 companies. These investments span six major sectors: big data analytics, patient engagement, digital medical devices, telemedicine, personalized medicine, and population health management. Pharmaceutical e‑commerce is likewise facing substantial growth opportunities. On May 28, 2014, the State Food and Drug Administration released the draft “Administrative Measures for the Supervision and Management of Internet-Based Food and Drug Operations,” which proposes allowing online sales of prescription drugs, lowering entry barriers for pharmaceutical retailers, and permitting e‑commerce platforms to partner with third-party logistics providers. Under the broader “Internet Plus” strategy, this regulation is expected to be finalized soon. Published on May 8 this year, the “Made in China 2015” initiative identifies biopharmaceuticals as a key priority area requiring vigorous breakthroughs: “Develop new chemical drugs, traditional Chinese medicines, and biotechnology-based therapeutics targeting major diseases, with particular emphasis on novel‑mechanism and new‑target chemical drugs, antibody therapeutics, proteins and peptides with entirely new structures, innovative vaccines, clinically superior traditional Chinese medicines, and personalized treatment agents.” The biopharmaceutical sector encompasses numerous specialized subfields, boasts cutting-edge technological content, and offers vast prospects. Take precision medicine as an example: on March 26 this year, the Ministry of Science and Technology unveiled China’s first Precision Medicine Initiative, announcing plans to invest RMB 60 billion in this field by 2030. Additionally, the “Made in China 2025” plan calls for enhancing innovation and industrialization in medical device manufacturing, focusing on developing high-performance diagnostic and therapeutic equipment such as imaging systems and medical robots, high-value consumables like fully biodegradable vascular stents, and mobile healthcare products including wearables and remote diagnosis tools. It also seeks breakthroughs and applications of emerging technologies such as bio‑3D printing and induced pluripotent stem cells. Due to late start-up, low initial conditions, and insufficient R&D investment, China’s medical device industry currently lags behind in technological sophistication. At present, there are approximately 15,000 medical device manufacturers in China, yet nearly 90% generate annual revenues below RMB 20 million. The 13th Five-Year Plan represents a major opportunity for advancing China’s high-performance medical device sector. For medical device manufacturers, the future holds immense potential—a vast blue ocean waiting to be explored.