Symposium on Technical Review of Medical Devices with the Center for Medical Device Evaluation (CMDE)

2023-05-31 | Beijing

On 31 May 2023, Jessica Yuan, deputy head of Government Affairs at the European Chamber attended the symposium on Technical Review of Medical Devices organised by the Center for Medical Device Evaluation (CMDE) to share suggestions collected from the Chamber's member companies.

SUN Lei introduced the future goals of CMDE which will focus on the promotion of regulatory science research, active participation in international cooperation and exchange with IMDRF, guidance and promotion of sub-center construction, and cultural development of former chemical centers.

Then, Sun Lei delineated three questions that lead to having an idea of what needs to be done in the next few years and what should be included in version 2.0 of the system in order to fight against the future challenges of CMDE:

a.       How much longer until the goal of double first-class?

b.       How far away is the goal of "clinically oriented restructuring of the review process?

c.       What are we missing in the modern review system architecture?

Finally, Sun Lei shared that the main goal of this symposium is to build a modernized review system version 2.0 where the main topics will be:

a.       Focus on the mission of "protecting and promoting public health with the people as the center", to listen to the opinions and suggestions on the overall work of the center;

b.       Focus on the quality development of the medical device industry;

c.       Around the building of the style of practice, with a better style of practice to ensure the development of the review business direction.

Jessica thanked CMDE for the public outreach which is excellent, such as the answers to common questions and the ware audit cloud classroom. She emphasized that the registration guidance books written by the ware audit organisation were very helpful in preparing the registration documents, especially the English version, which accelerated the understanding of Chinese regulations by overseas corporate headquarters and that the responses to the comments were each very carefully answered and some of the issues have been effectively addressed.

Regarding the modernised review system version 2.0, Jessica mentioned the following points:

- About the software upgrades, it is recommended to link applications related to software upgrades (which can be considered to be designed in the eRPS system) and try to link to projects that have already been reviewed in order to improve

- About existing registered products as system components, it is recommended that only the registration numbers and the relevant validation and performance requirements for the matching part of the system are provided;

- For electronic certificates, it is recommended that the stamp of the NMPA can be added to the electronic technical requirements as well;

- It is advisable to pre-communicate with the applicant by telephone prior to issuing a formal opinion;

- For video consultations involving two reviewers from the "Technical Review Department and Clinical Department", it is recommended that each department be given three consultation opportunities.

Regarding the encouragement of innovation, Jessica mentioned the following points:

- For products that are already in the innovation pipeline, a modular cross-review of the proposed submission (i.e., one data preparation, one review, e.g., PTR test report, performance validation) is conducted to further accelerate the review of innovative products;

- For data security-related reviews, it is recommended that the manufacturer's server or cloud service location is not required, but the manufacturer should be certified and approved in accordance with the requirements of cybersecurity-related laws and regulations;

- For medical device registration submission, it is recommended that the registrants submit registration information for registration filing in accordance with the relevant requirements of the software and cybersecurity review guidelines (innovation + national development omitted).

Regarding the intersectoral area, Jessica mentioned the following points:

- About the registration changes due to recall, it is recommended to have the priority review channel - regarding livelihood safety, recall level may be considered (life safety);

- Medical insurance name association, coordination and cooperation with other departments of the Drug Administration, and other government departments.

Sun Lei believed that all the issues addressed by the companies and associations were related to the significant lack of human resources at CMDE. He also emphasized that human talent resource is one of the core factors for the Center to operate well.

Sun Lei concluded the symposium by thanking all the company and association representatives for their sharing and contributions because they are all very meaningful and important for the center in improving their services in the future.