Clinical Evaluation for Medical Devices in China
January 16, 2024The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing. Just as in the EU, clinical evaluation is a crucial aspect of ensuring the safety and efficacy of medical devices in China.
Regulations for clinical evaluation
In China, the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA), is the authority that regulates the registration and supervision of medical devices. The NMPA has issued several documents that provide the general and specific requirements for clinical evaluation, including:
- The Regulation on Supervision and Administration of Medical Devices, which is the main legal framework for medical device regulation in China.
- Measures for the Administration of Registration and Recordation of Medical Devices, which specify the registration procedures, dossier requirements, and approval criteria for medical devices.
- The Technical Guidance on Clinical Evaluation of Medical Devices, which provide the principles, methods, and standards for conducting clinical evaluation of medical devices.
Is CER required for all medical devices?
Manufacturers must issue a clinical evaluation report (CER) for registration. However, CER can be waived in the following cases:
- Medical devices with a clear working mechanism, finalized design, mature production process, and a similar medical device that has been clinically used for many years on the market without any serious adverse events records and does not change the normal use.
- Medical devices that can be demonstrated to be safe and effective through non-clinical evaluation.
The class I products fulfill the criteria above, hence the CER is not mandatory.
Furthermore, NMPA published the latest CER Exemptions List in July 2023, which includes 1,025 Class II to Class III products, and their CERs are not required.
Clinical evaluation for total product life cycle
Clinical evaluation must be conducted continuously throughout the entire life cycle of medical devices, encompassing the following phases:
- Phase 1 - Concept Development: During the concept development stage, clinical evaluation focuses on defining the device's intended use, target population, and clinical needs. This involves reviewing available literature, conducting preclinical testing, and developing a preliminary risk management plan. The goal is to establish the foundation for further clinical evaluation and risk mitigation strategies.
- Phase 2 - Design and Development: As the device design progresses, clinical evaluation refines its assessment based on the evolving device characteristics. It identifies potential risks associated with the design, documents design decisions, and conducts additional preclinical testing and clinical trials if necessary.
- Phase 3 - Post-Market Surveillance (PMS) : Once the device is launched on the market, clinical evaluation transitions to a continuous PMS phase. This involves actively collecting and analyzing clinical data from real-world use. Adverse events are promptly identified and reported, and the device's performance is monitored in diverse patient populations and settings. The updated information serves as input to risk management and may result in changes to risk assessments, clinical evidence, labeling, Instructions for Use (IFU), and post-marketing activities.
Clinical evaluation pathways
The following diagram illustrates the pathways for clinical evaluation in China (Figure 1):
Manufacturers can choose the appropriate evaluation path or a combination of paths based on the technical characteristics, scope of application, existing clinical data, and other specific conditions of the applied product.
The Equivalent Pathway allows manufacturers to leverage existing clinical data from other devices to support the clinical evaluation of their device. This pathway can be further divided into two approaches:
- Through clinical data of equivalent devices: This approach involves using the clinical data of an equivalent device that has been approved by the NMPA to support the clinical evaluation of the device under evaluation (DUE). An equivalent device is one that has either the same intended use, technical characteristics, and biological characteristics or the same intended use, similar technical characteristics, and biological characteristics as the DUE. In this case, manufacturers must submit sufficient scientific evidence to demonstrate that differences in technical and biological characteristics have no significant impact on clinical safety and performance.
- Through clinical data of comparable devices: Comparable devices have similar intended use, technical, and biological characteristics. The clinical data from comparable devices could be utilized as part of the clinical evidence to support the clinical evaluation of the DUE. Manufacturers must explicitly elucidate the role of clinical data from the comparator device, for example, to support the safety of a component of the DUE or to support one clinical claim of the DUE. Furthermore, based on the similarities and differences between the DUE and the comparator device, a rationale must be presented to justify the use of clinical data from the comparator device.
Clinical trials are one way to obtain clinical data for the DUE. They can demonstrate that the DUE has the same safety and effectiveness as its comparable device when differences exist. Clinical trials can also serve as the main clinical evidence for the DUE. These trials can be conducted within China, outside China, or as multi-regional clinical trials. The specific type of clinical trial will depend on the device's characteristics and the available clinical evidence.
Clinical evaluation process
Once the evaluation scope is determined, the clinical evaluation comprises three stages (refer to Figure 2):
- Identify the available clinical data that are relevant to the device and its intended use. This data may come from a variety of sources, including literatures, clinical trials, observational studies, and post market surveillance data.
- Evaluate the suitability and contribution of each data set. This evaluation considers the quality, quantity, and relevance of the data.
- Analysis of datasets and derivation of conclusions. Analyze each data set to draw conclusions related to product safety, clinical performance, and effectiveness, as well as information relevant to the clinical use of the product. Ensure that the instructions for use are consistent with clinical data and that all hazards and other relevant clinical information are listed.
A CER will be drafted, incorporating relevant clinical data to form the basis of clinical evidence. If the available clinical evidence is insufficient to demonstrate compliance with the fundamental principles of safety and performance, manufacturers may need to generate new data (e.g., by conducting clinical trials or expanding the scope of literature searches). Consequently, the clinical evaluation process may iterate through the aforementioned stages.
Structure and content of CER
The CER is typically divided into the following sections:
- Product Description and R&D (Research and Development) Background: Provide essential details about the DUE, including its name, model, and relevant manufacturing information. Clearly define the intended use. Explain the working principles and/or mechanisms, including relevant scientific concepts. Discuss the background and purpose of the device's research and development.
- Scope of Clinical Evaluation: Based on the technical characteristics and intended scope of the declared product, clearly define the scope covered by the clinical evaluation.
- Clinical evaluation pathways: Manufacturers may choose one or two evaluation pathways based on the device's technical features, intended scope, and existing clinical data.
- Clinical data evaluation and analysis:
- Data from equivalent device, like literature, serious incidents, FSCA, recalls
- Data from comparable device
- Data from clinical trial
- IFU, labeling. Clearly articulate whether the information provided in IFU and labeling is supported by adequate clinical evidence.
- Conclusion: The comprehensive analysis of clinical evidence, along with other design verification documents, device descriptions, labels, risk analyses, and production information, could demonstrate safety and performance of the DUE. The risks associated with device use are acceptable compared with its benefits.
- Qualification of Clinical Evaluators: Experience of clinical evaluators, including product technology and its use; clinical research methods (such as clinical trial design, biostatistics); diagnosis and management of the disease.
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