China Clinical Trials
China has emerged as a significant player in the global clinical trials landscape, with a growing number of trials being conducted within the country.
The need to perform studies for your device or IVD for the purposes of product approval in China varies depending on their risk classification, whether exemptions exist, and the legal requirements for clinical data.
The complexities and regulatory requirements surrounding clinical trial approvals in China can affect the efficiency of the trials, with necessary documentation and quality control challenges.
Considerations Before Starting CTs in China
Clinical Trial Exemptions
Qualifying for an exemption usually means that the device or the IVD is listed in their respective exemption catalogues:
Although IVDs included in the exemption list can avoid general trials, clinical studies in China are usually unavoidable.
The National Medical Products Administration (NMPA) publishes and updates these clinical evaluation exemption lists, known as catalogues, on a regular basis. Please check with us to determine if your product is on these lists.
Predicate Comparison
A clinical study may not be necessary if you can demonstrate substantial equivalence to an approved device or IVD in the People's Republic of China (PRC) through a CER.
Please note that if there are significant differences in the intended use, technical features, or biological characteristics compared to devices already approved in the PRC, the product is generally classified as a new type of device. In such cases, the predicate device pathway is typically not applicable, and a clinical evaluation is usually required based on study data—either from a trial conducted overseas or in the PRC.
Use of Overseas Data
If the declared product has undergone studies outside the PRC that meet or exceed the requirements of Chinese regulations, the product can avoid having to undertake studies in the PRC.
Use of Real-World Data
Another alternative is the use of Real-World Data from sources such as patient-generated data or data derived from electronic health records. As specific guidelines for RWD have not yet been released, this data is typically used as supplementary information in Clinical Evaluation Reports.
Risk Classification
China Clinical Trials Registry
The Chinese Clinical Trial Registry, established by the NMPA, serves as the primary registry, providing a centralized platform for trial application, approval, and monitoring.
This registry is a crucial tool for ensuring transparency and accountability in clinical research. It allows for systematic tracking, from their inception to completion, ensuring they meet the stringent regulatory standards set by the NMPA. This registry not only facilitates the approval process but also helps in maintaining high standards of quality control and compliance with the Personal Information Protection Law.
Clinical Trial Process for MDs & IVDs in China
There is a structured process and procedures to follow to ensure the study meets NMPA regulatory requirements. Here is an overview of the key steps:
1
Development & Strategy Consulting
2
Ethics Approval & Trial Registration
3
Conducting the Clinical Trial
For implants or other high-risk devices, preclinical animal studies are often required before the human trial stage to validate safety and biocompatibility.
4
Data Collection, Analysis, & Clinical Trial Report
5
Submission to the NMPA
The CTR and trial protocol must be included in the submission dossier when applying for device and IVD marketing authorization. The NMPA will review the data to assess whether the necessary safety and efficacy standards have been met.
Cisema's China Clinical Trials Services
We make medical device and in vitro diagnostic (IVD) CTs in the PRC easier by guiding you through Chinese regulations, Good Clinical Practice (GCP) standards, and ethical requirements. With our expert support, we help you navigate the process smoothly, stay compliant, and move efficiently toward marketing authorization.
Our services include:
CT Strategy & Regulatory Assessment
We design tailored clinical development strategies aligned with product type, classification, and regional requirements. Our roadmaps integrate regulatory timelines, resource planning, and clinical milestones to support both early-stage feasibility and late-stage execution.
Type Testing & Pre-Trial Preparation
Clinical Trial Execution Support
Data Management & Submission
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China NMPA IVD Registration
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NMPA Clinical Evaluation Report
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We are your authorized representative in China, and fulfill your registrations and filings as well as ensuring compliance and PMS requirements.
NMPA Type Testing
Our on-site test engineers coordinate and supervise type tests of your medical products in NMPA-accredited laboratories.
Device PMS & Vigilance
The NMPA is placing greater focus on Post-Market Surveillance (PMS) such as more in-market sampling inspections and regular standard changes.Our specialist PMS team means you stay up to date with the many aspects of compliance.
Regulatory Outsourcing
If you are seeking specific specialist expertise or have ongoing resource-intensive needs, we have a variety of solutions to meet your needs.
China Device Quality Compliance
We help you achieve and ensure ongoing compliance with Chinese requirements.Our experts prepare and assist you for official NMPA inspections.
