Medical Device Clinical Trial Phases in China: A Practical Step-by-Step Guide

Going through China’s medical device clinical trial phases can be painstaking in terms of the cost and time. While more and more clinical exemptions have been issued by China’s NMPA (in fact, a total of 1,002 medical devices and 401 IVDs are now exempt from clinical trials in China since the first exemptions catalog published in 2014), higher-risk devices and devices with new design, new mechanism and new materials are still required to pass clinical trials in China.

Clinical Trial Key Regulations

Apart from “Medical Device Clinical Trial Quality Management Practice” (China Medical Device GCP) published on March 1, 2016, there are specific decrees and guidelines governing ethics review, filling document requirements, applicable clinical trial sites, on-site inspection, etc; The IVDs and passive implantable devices have their own regulations.

The following lists the essential laws and regulations in China’s clinical trial arena:

Contact us at info@inspirativemed.com for English copies of the files on this list. We charge a nominal fee for the translation.

Medical Device Clinical Trial Phases & Steps in China

Device clinical trials in China can be divided to the following phases and steps:

1. Submit your Clinical Trial Application to NMPA’s national headquarters, if your device is listed on the “Catalog of Class III Medical Devices Requiring Clinical Trial Approval”
2. Prepare your clinical study documentation
3. Conduct trial site evaluation and selection

More about site evaluation and selection:

Please note that 32% of all hospital beds in China are concentrated in the largest 20 cities. Therefore, carefully choosing your clinical trial location(s) in China will certainly help reduce the trial duration and improve the efficiency of your clinical trial. Check out our blog “Concentrated Care in China Facilitates Clinical Trial Recruitment and Data Gathering” to find out more about the concentration effect of China’s health care system.

Let Bradynuoen help you select local hospitals in China that are best suited for your indication of device. We have established long-time partnership with some of the most renowned hospitals in China. Contact us for our article on 846 certified medical device clinical trial sites in China.

4. Prepare for protocol discussion meeting with NMPA

More about clinical trial protocol:

The protocol design should strictly follow NMPA (formerly CFDA)’s Medical Device Clinical Trial Design Guideline issued in January 2018 and the Clinical Trials Guideline for In Vitro Diagnostic Reagents (Draft) issued in Nov 2018.

NMPA reviewers will thoroughly examine all aspects and details of your protocol. For example, the intended use must be identical to the description of the intended use from the IFU; The sample collection requirements for the control product must follow the IFU; The study method must include a clinical trial flow chart, etc.

5. Project establishment in trial sites
6. IRB review and approval
7. HGRAC approval

More about HGRAC approval:

Any devices or IVDs involving genetic information must be registered with Human Genetic Resources Administration of China (HGRAC), otherwise your clinical trial will run into the possibility of being rejected.

8. Clinical trial agreement signing
9. Provincial/ local NMPA filling
10. Site initiation
11. Patient recruitment & enrollment

More about patient recruitment & enrollment:

In the past, Bradynuoen successfully completed a clinical study for world’s first CT-Linac, manufactured by United Imaging. For this study, we recruited seventy late-stage cancer patients across three sites in China. Our team has also overcome the challenge of coordinating investigators from different therapeutic areas in this study. With a partnership with Bradynuoen, this innovation device was approved by NMPA in December 2018.

12. Treatment & observation
13. Follow-up
14. Interim analysis (if applicable)
15. Data collection
16. Data management

More about data management:

Data management in China can be tricky. It requires not only technical expertise but also regulatory know-how: Are these image evaluation records related to the clinical trial complete? Have the original records of the clinical trial cases recorded reasons and times of the modification? Are there any screening records for the samples?

Contact us for common issues in NMPA’s Clinical Trial Audit process that involves data mismanagement and more,

17. Data Q&A
18. Database lock
19. Statistical analysis

More about statistical analysis:

As NMPA clinical audits intensify over recent years, many manufacturers have been caught in the clinical statistics part from the clinical trial audit, including some big names.

20. Summary meeting
21. Site summary report
22. Clinical study report (CSR)
23. Study close-out
24. Site close-out