CLINICAL TRIAL SERVICES FOR ACCELERATION OF YOUR MEDICAL DEVICE APPROVAL IN CHINA
Successfully conducting a clinical trial in China opens the door to one of the world’s largest and fastest-growing healthcare markets. With the right expertise and guidance, the process can be smooth and efficient. As a leading international Contract Research Organization (CRO), Cisema specializes in assisting medical device and IVD manufacturers navigate China NMPA clinical trial requirements with complete confidence.
Our expert technical team ensures regulatory compliance, trial execution, and data management—helping global companies achieve fast and successful approval in China’s highly regulated market.
Understanding China’s Clinical Trial Requirements
The necessity of a clinical trial in China depends on the device classification and the availability of clinical data. Class I medical devices are exempt from clinical trial requirements, while Class II and Class III devices may require clinical trials unless they qualify for an exemption. Medical devices and IVDs across all classes are subject to clinical data requirements, though some may be eligible for exemptions.
You may qualify for an exemption from clinical trials based on alternative clinical evidence, such as:
Predicate Comparison: If substantial equivalence to an already NMPA-approved device can be demonstrated through a Clinical Evaluation Report (CER).
Acceptance of Overseas Clinical Data: The NMPA may consider foreign clinical data, though additional China-specific trials or bridging studies may still be required.
Real-World Data (RWD) Utilization: Supplementary clinical evidence derived from patient records, electronic health data, and real-world studies.
The Cisema life science team can assist you in determining whether your medical devices and IVDs are eligible for a clinical trial exemption.
Overview of Our China Clinical Trials Services
Navigating China’s clinical trial process requires expertise in regulatory compliance, ethics approvals, and data integrity. Our life science team ensures your clinical trial meets NMPA requirements, from drafting a compliant protocol and securing ethics approval to patient recruitment, trial execution, and data analysis. We manage the entire process, including Good Clinical Practice (GCP) compliance, adverse event monitoring, and final Clinical Trial Report (CTR) submission for NMPA approval. With our support, you can accelerate your path to market with confidence.
Acting As Clinical Trial Agent
In addition to managing your clinical trial operations, Cisema can also serve as your official NMPA-compliant clinical trial agent in China. As clinical trial agent, we assist in fulfilling a manufacturer’s legal responsibilities under Article 36 of the Good Clinical Practice for Medical Devices (2022 Edition). This includes ensuring trial authenticity, overseeing regulatory compliance, managing provincial authority filings, coordinating investigator training, and assuming responsibility for subject compensation and adverse event reporting. Our legal agent services ensure your clinical trial is fully aligned with NMPA requirements and executed with clear and independent China representation.
Before production begins, we evaluate the quality of raw materials and assess the setup of your production lines. This early inspection helps identify potential issues, ensuring that everything is in place to meet your quality requirements.
We aim to prevent delays, defects, and costly mistakes in the production process.
A successful clinical trial starts with thorough pre-trial planning to ensure compliance and minimize delays. We support you with:
- NMPA-Designated Lab Testing Coordination – We assist in arranging local type testing at accredited Chinese laboratories to meet NMPA’s unique performance and safety standards.
- Clinical Trial Protocol (CTP) Development – Our team drafts China-compliant clinical trial protocols, clearly defining study endpoints, methodology, patient selection criteria, and data collection procedures.
- Ethics Committee (EC) Approval & Documentation – We prepare and submit ethics approval applications, ensuring all required documentation is completed for a smooth review process.
- NMPA Trial Registration (If Applicable) – Where necessary, we handle trial registration with the NMPA, including submission of required documents. We aim to prevent delays, defects, and costly mistakes in the production process.
Once approvals are in place, we manage trial execution to ensure compliance with GCP guidelines and NMPA requirements. Our services include:
1. Accredited Trial Site Selection & Contract Negotiation – We assist in identifying and securing partnerships with NMPA-approved clinical trial sites and experienced investigators, negotiating contracts with hospitals and research institutions.
2. On-Site Trial Monitoring & Compliance Oversight – Our expert clinical research associates (CRAs) oversee trial progress, ensuring protocol adherence, patient safety, and regulatory compliance.
3. Adverse Event (AE) Reporting & Safety Monitoring – We implement robust pharmacovigilance measures, handling adverse event reporting, risk assessments, and necessary safety updates to regulators.
Following trial completion, we provide comprehensive data management and regulatory submission support to facilitate approval.
- Regulatory-Compliant Data Collection & Analysis – We ensure high-quality, reliable data collection in compliance with NMPA submission standards, minimizing risks of rejection or delays.
- Clinical Trial Report (CTR) Preparation – Our team compiles a detailed CTR, summarizing trial outcomes, safety profiles, and efficacy data to support regulatory evaluation.
- Full Support for NMPA Submission & Follow-Up – We prepare all required submission documents, liaise with regulators, and manage any additional queries from the NMPA to ensure a smooth approval process.
The Cisema team can also provide support to your organization in other important 4 areas:
1. Legal & Regulatory Support – legal consultation and legal agent services.
2. Site Selection & Trial Setup – site evaluation visits and site management.
3. Pre-Trial Documentation & Compliance – documents management and clinical trials related medical device clearance
4. Data Analysis & Reporting – statistical analysis and clinical evaluation assessment reports.
Partner with a Trusted CRO
Our expert team provides personalized solutions tailored to your needs, helping you navigate China’s complex approval system and achieve market success faster.
– Client-First Approach: We prioritize your needs by offering dedicated guidance throughout every stage of the clinical trial process. Our team works closely with you to develop customized strategies, address regulatory challenges, and ensure efficient project execution.
– Strict Quality Control: We uphold the highest standards of regulatory compliance, ensuring data accuracy, completeness, and reliability. Our rigorous quality assurance framework aligns with NMPA requirements, enabling a smooth approval process and minimizing the risk of regulatory setbacks.
– End-to-End Support: From feasibility analysis and regulatory strategy development to trial execution and final submission, we provide comprehensive support at every stage. Our integrated approach ensures that all regulatory, technical, and operational aspects of your clinical trial are managed effectively.
Upgrade Your Understanding about China Clinical Trials
Navigating China’s clinical trial and NMPA medical device registration process can be complex, but our exclusive whitepaper helps simplify the path to compliance. From understanding regulatory pathways to mastering post-market requirements, this guide equips you with the insights needed to conduct clinical trials and register your medical device in China efficiently.
Topics covered by this whitepaper:
- Latest NMPA regulations & clinical trial requirements
- Key steps for clinical evaluation & type testing
- Compliance strategies for post-market surveillance
- How to leverage special access routes like Hainan & Hong Kong
Testimonial of our China Clinical Trial Service
“We worked with Cisema Limited on the product approval of medical devices in China. We are very satisfied with the implementation of the task and the concrete results. We were able to successfully complete the re-registration on time. We can fully recommend Cisema Limited.”
Long-established Medtech Manufacturer in Germany
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Request a Proposal from our Life Sciences team for your China Clinical Trial
FAQs about our China Clinical Trial Service
It depends on the classification of your device and whether it qualifies for an exemption.
- Class I medical devices: Clinical trials are not required.
- Class II & III medical devices: Clinical trials may be necessary unless they are listed in the NMPA’s Clinical Evaluation Exemption Catalogue.
- IVDs (In Vitro Diagnostics): All classes (A to C) may require clinical trials unless exempted.
You may also avoid a clinical trial if you can demonstrate substantial equivalence to an already approved device in China through a Clinical Evaluation Report (CER).
The NMPA (National Medical Products Administration) regularly updates exemption lists for medical devices and IVDs. A clinical trial is not required if your product appears in one of these lists:
- NMPA Medical Device Clinical Evaluation Exemption Catalogue
- NMPA IVD Clinical Evaluation Exemption Catalogue
Additionally, clinical trials may not be required if sufficient overseas clinical data or real-world data (RWD) can support the registration, but this depends on NMPA acceptance.
The NMPA may accept overseas clinical trial data, but China-specific trials or bridging studies might still be required.
- If your device has already undergone international clinical trials, this data may be used as supporting evidence in a Clinical Evaluation Report.
- However, the NMPA typically prefers local Chinese clinical data to ensure the device’s safety and efficacy within the country’s specific population and healthcare environment.
Conducting a clinical trial in China involves several key steps:
- Drafting a China-compliant Clinical Trial Protocol (CTP) – The study design, endpoints, patient selection criteria, and data collection methods must align with NMPA regulations.
- Ethics Approval & NMPA Registration – The trial must be approved by an Ethics Committee (EC) and registered with the NMPA before initiation.
- Trial Execution & Monitoring – The study is conducted at accredited clinical sites following Good Clinical Practice (GCP) guidelines.
- Data Collection & Analysis – The collected data is analyzed to determine the safety and effectiveness of the device.
- Final Clinical Trial Report Submission – The trial results are compiled into a Clinical Trial Report (CTR), which is submitted as part of the NMPA registration dossier.
The timeline varies depending on factors such as the complexity of the study, patient recruitment speed, and NMPA review processes. Generally, a full clinical trial process can take 12 to 24 months.
However, regulatory approvals, site selection, and ethics committee review can add additional time, so early planning is recommended.