- What are innovative medical devices?
The core technology of the product has Chinese patent right for invention, or the application for invention patent has been reported to the Patent Administration Department under the State Council of China. The main working principle or action mechanism of the product is the first in China, and the product has significant clinical application value.
- What is the special examination and approval mode for innovative medical devices?
NMPA implements the Special Evaluation and Approval Procedure for Class II and III medical devices meeting the following conditions at the same time (effective as of October 1, 2018).
Through their predominant technological innovation research, the applicants legally own the patent right of the product’s core technology invention in China, or obtain the invention patent or use right in China by legal transfer.
The main working principle or action mechanism of the product is the first in China. The product performance or safety has radically improved compared with predicate devices. The technology is at the international leading level and has significant clinical application value.
The applicants have finished the preliminary research on the product, and have basic prototype products. The research process is authentic and controlled, and the research data are complete and traceable. Information on the product under the application to be submitted should include:
1. The applicant’s enterprise legal person qualification document.
2. Intellectual property right of the product and supporting document.
3. Overview of the R&D process of the product and results.
4. The technical documentation of the product (including at least: scope of application/intended use of the product; action mechanism of the product; main technical indicators and basis; and indicator requirements of raw materials and key components, production process and inspection methods.)
5. Supporting documents of product innovation (including at least: summaries of academic papers, monographs and documents published in core publications to fully demonstrate the clinical application value of the product; analysis and comparison of the application of predicate products that have appeared on the markets at home and abroad; innovative content of the product and significant value in clinical application.)
6. Product risk analysis data.
7. Product Description.
8. Other materials that can prove that the product complies with Item 2.
9. An overseas applicant should entrust a legal person in China to act as its agent or its office in China to file the application and to submit relevant documents.
10. Statement of self-assurance on the authenticity of the materials submitted.
- How about the management of medical artificial intelligence in China?
In January 2019, China released “China’s White Paper on Artificial Intelligence”, which provides references for China’s policy making, academic development, investment decision making and product application of the artificial intelligence medical system. According to the new edition of the Classification Catalogue of Medical Devices, the current artificial intelligence medical treatment can be divided into three parts: drug calculation, computer-aided diagnosis/analysis, and TCM diagnosis and treatment.
- How to register 3D Printing Medical Devices in China?
3D printing medical device is known as “customized additive manufacturing medical device” in China, which is still in the stage of opinions-soliciting. According to the existing technical review guidelines, the registration elements include design method (including software), composition of device materials, process method, scope of application, key functions, etc.
- How to register wearable medical devices?
Wearable medical devices are known as “mobile medical devices” in China, and the product structure consists of software and hardware. Mobile wearable medical devices that do not contain medical device software are not mobile medical devices. Independent software can be considered as a mobile medical device.