Update on the Knows and Dos for innovation pathway
On November 5th, 2018, National Medical Products Administration (NMPA) issued 'Special Review Procedures for Innovative Medical Devices'
Order 83 to replace the Procedure trial version published in 2014. The purpose is to encourage innovative device research and development further, promote the application of new medical technology in the healthcare industry, and streamline the application process.
Together with the Priority Evaluation Approval and Emergency Usage Approval, these three routes are the basis for a fast-track review system in China.
Knows about innovation pathway
Scope of innovation application
- Class II and Class III medical devices.
Conditions for applying innovation
- The applicant shall possess the core technical patent of the product in China; or obtain/authorize to use the core technical patent of the product via a legal transfer procedure, or the application for the core technical patent has been published by the China State Council. The application shall be made within five years of the patent grant date.
- The applicant must have completed a preliminary study and established a prototype. And the research procedure must be authentic and controlled. The research data must be intact and traceable.
- The product's main working principle/mechanism is first in domestic China. The device's performance and safety have fundamental improvements compared with similar devices, and the technology is globally leading and has significant clinical applications.
Evidence to support the innovation
- Academic papers, monographs, and literature reviews publicly published in core journals fully demonstrate the clinical application value of the device.
- Analysis and comparison of the application of similar products launched domestically and internationally.
- The innovative content of the product and its significant value in clinical application.
Innovation application process
A high-level overview of the process and timelines is presented in figure 1
Figure 1. Schematic process overview of the innovation application
Deadline to initiate the registration application
Once the product is approved for the innovative pathway, the innovation registration shall be initiated within five years of the initial approval.
Benefits of being on the innovation pathway
- Early intervention: The applicant will be assigned with a dedicated technical reviewer to discuss the regulatory and clinical requirements covering the device's life cycle.
- Shorter timeline: The application will enjoy prioritized Good Manufacturing Practice (GMP) audits, product type testing, and technical review procedures with a shortened timeline.
We often receive questions about the innovation pathway. Below are some common questions and answers presented. Could the product be changed under the innovation review process?
Once the product is already approved and reviewed under the innovation, the main working principle or mechanism of action change will trigger a new application. Clinical trial protocol revision, usage methods update, specifications, intended use, applied location, and population change shall consider the impact on the intended device's safety and performance and quality controllability.
Is a pre-market clinical trial study a must?
A clinical study is not a must to prove the device's clinical value. However, trial data could be strong and convincing evidence to improve the success.
If the product is already submitted for the regular submission route, can the innovation application still be applied or vice versa?
Yes, regular submission and innovation submission can be arranged in parallel.
How many experts will be present at the expert panel meeting?
5-7 experts in the relevant areas will be randomly selected for presence.
How many devices have been approved so far?
Until April 2023, 202 devices have been approved into the market via the innovative pathway. The devices are imported from the US, Israel, Korea, and Canada. Some imported devices are as follows:
- Medtronic: percutaneous implanted aortic valve system- CoreValve Evolut PRO System
- Medtronic: Transcatheter Leadless Pacemaker System
- Medtronic MiniMed: Hybrid Closed Loop Insulin Delivery System
- NovoCure Ltd: Tumor electric field therapy instrument
- Biosense Webster (a subsidiary of J & J): 3D multichannel radiofrequency balloon catheter
- Abbott Vascular: MitraClip System
- Sequent Medical Inc: Self-expanding intra-arterial embolization system
- W.L Gore & Associates Inc: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Ethicon LLC: SURGICEL Powder and SURGICEL Endoscopic Applicator
- Ubiosis Co.Ltd: COLTRIX CartiRegen
- Alcon Lab: intraocular lens
- Conavi Medical Inc: Novasight Hybrid System
Based on CMDE data in 2022, 343 applications have been received, while 68 applications have been approved. The success rate is 19.8%.
Considering the relatively low success rate, what shall be considered to prepare the application?
- 45-minute presentations shall be prepared and targeted at the expert panel as an audience.
- The expert panel meeting is based on a video recording from the manufacturer presenting its technology. The expert panel will then vote if the device can be allowed into the innovation pathway. There is no Q&A between the expert panel and the manufacturer. Video recording must be easy-to-follow logic as the driving force will prevail in the paperwork presentation.
- To show the intellectual property, the manufacturer must provide a copy of the patent authorization certificate, claim letter, instruction manual, and the original copy of the patent registration book issued by the China patent authority with the applicant's signature and seal. The patent shall be from China and focus on the core technology, patents from other territories are not recognized.
- Comparison with similar products shall provide a description of the search results for similar products that have been listed in China. It includes the search database, search date, search keywords, and the results obtained from each search keyword. It analyzes the differences in working principles or mechanisms between the applied medical device and similar products approved. Provide comparative analysis materials that support products that are technologically leading internationally.
- If the first application is failed or rejected, a second one may also be prepared and considered the possible failure reason in the first round.
- Product description shall be comprehensive to consider both old and new experts. Part of the experts will be those who rejected the initial application in the first round, and the rest of the experts will be randomly selected from the expert panel database.
Qserve may provide a complete list of innovation device approvals from 2014 until 2023. Feel free to contact us to obtain a copy or discuss the innovation pathway strategy and document preparation. More blogs
from Stephanie Huang on China's regulatory pathway:
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