Want to know the registration and evaluation of a medical device, understand the market, how to query these data?

To do device research and understand the market, we can start with the registration and approval of medical devices in China. The database of medical device registration and evaluation is integrated from several official data of the State Administration of Pharmaceutical Products (NMPA) and the Medical Device Technical Evaluation Center (CMDE) of the State Administration of Pharmaceutical Products. At present, it contains nearly 22W+ data, including all acceptance numbers and their processing status published by NMPA and CMDE, and has been systematically sorted out. In-depth processing is helpful to understand the application content, application type, approval progress and evaluation conclusion of medical devices and provide decision support. It is an important tool to master the registration information of devices, which is convenient for quickly inquiring about the evaluation of target varieties, tracking the progress of device research and development in real time, understanding and mastering the research and development trend, helping enterprises to establish scientific projects, adjusting product sales strategies in time and avoiding risks.

Medical device review

You can search keywords by acceptance number, product name and enterprise name, and search dates by status start date, approval date and evaluation conclusion date. You can also filter the conditions according to the approval progress, whether to give priority to innovative special review, evaluation report, clinical trial mode permission, application type, application content, evaluation conclusion, charging situation and domestic/import, and inquire about the registration progress, application content and application content of a medical device or a device manufacturer you want to know.

For example, if you want to inquire about the registration review of a pharmaceutical company, you can search the company name "jiangsu hengrui Pharmaceutical Co., Ltd." and select "Being Accepted" in the approval process to inquire about the medical device information being accepted by the company.

Registration review

Click "Acceptance Number" to enter the details page, which contains the basic information of medical devices (acceptance number, product name, enterprise name, approval progress, priority approval, whether registration is recommended, evaluation report, whether clinical trial is approved, clinical trial approval opinion sheet, application content, application type, evaluation conclusion, charging situation, approval date, status start date, evaluation conclusion date, domestic/imported, official link.

Medical instruments