On November 25, 2021, the NMPA (National Medical Products Administration) issued (No.91 – 2021) the technical review guidelines for the registration of medical devices and IVDs concerning the clinical trial data submission requirements.
Highlights
- Medical Device Clinical Trial Data Submission
- Scope of application: Applicable to clinical trials of medical devices for the purpose of product registration, including overseas clinical trials; Not applicable to clinical trials of In Vitro Diagnostics.
- Basic principles of data submission: Authenticity, traceability and readability.
- Submission form requirements: Clinical trial data of medical devices usually include original database, analytical database, explanatory documents and procedure code. The guideline provides requirements and provisions on the specific format and content of each application data. Applicants are encouraged to submit Data in accordance with the Clinical Data Interchange Standards Consortium (CDISC) Standards. The original database, analysis database, illustrative files, and program code are placed in four separate folders.
- In Vitro Diagnostics Clinical Trial Data Submission
- Scope of application: Applicable to in vitro diagnostics clinical trial carried out for the purpose of product registration, including overseas clinical trial.
- Basic principles of data submission: authenticity, traceability, readability and comprehensiveness of data.
- Requirements of Clinical trial database contents: In general, clinical trial database content shall include information about subjects and test information of clinical trial samples. The guideline specifies data information that should be included in different types of clinical trial design.
- Requirements of submission form: Applications relating to in vitro diagnostic clinical trial data usually include the original database, analytical database, explanatory documentation and procedure code (if any). The guidelines specify the specific format and content of each application. Applicants are encouraged to submit Data in accordance with the Clinical Data Interchange Standards Consortium (CDISC) Standards. The original database, analysis database, illustrative files, and program code (if any) should be placed in four separate folders.
By Alice Liu and Jacky Li. Cisema regularly support clinical trials in China as a CRO. For our clinical trial protocol and preparatory studies, or more details about full clinical trial support in China, please inform us.
