Good news! Remote Video Review Pilot Points Increased for Innovative Medical Devices

  • 2019-05-23
One remote video review pilot point will be increased for innovative medical devices.

Center for Medical Device Evaluation, NMPA (hereinafter referred to as CMDE) will remotely review the applications for the review of innovative medical devices submitted by foreign enterprises through the video platform of the Medical Device Working Group of EUCCC.

The news was got by the reporter at the Innovative Medical Device Review Dialogue and eRPS Training Implementation Activity by the Innovation Center of EUCCC (hereinafter referred to as the Implementation Event) held in Beijing on May 17.

At the Implementation Event, the leaders of CMDE told over 60 representatives of EUCCC from such enterprises as Roche, Johnson & Johnson and GE Healthcare, the eRPS system of NMPA would be used within the year, and then "paperless" medical device registration, application and evaluation would be achieved, and it is expected to speed up the medical device evaluation and approval.

216 innovative products reviewed and imported items lessened
Jiang Jie, Vice-Chairman of the Medical Device Working Group of EUCCC, introduced that, as the global medical device market is active, it is expected that total spending of medical devices in the major global markets in 2030 would be about USD 800 billion and the market scale in China would be USD 200 billion to become the second largest medical device market in the world.

The fast-growing market promotes innovation. In order to encourage the development and import of innovative products, the former China Food and Drug Administration issued Special Review and Approval Procedures for Innovative Medical Devices (trial) in February 2014 and set up a special review channel for medical devices that got invention patents in China, used the original technology in China, took a leading position in the word, and had significant clinical value.

In November 2018, NMPA issued the revised Special Review Procedures for Innovative Medical Devices, further determining the review items and improving the review procedures.

The implementation of the procedures facilitated the promotion and use of new technologies in medical devices. According to data from CMDE,

Annual applications for special reviews of innovative medical devices continued to grow from 2014 to 2018, and there were 316 applications in 2018, about 2.3 times of those in 2014. The highest approval rate is 26.4% in 2017.

"From 2014 when the procedures are implemented to the end of March 2019, CMDE received 1,135 applications for special reviews of innovative products, among which 216 applications were approved, and 78 applications entered the evaluation process, accounting for 36% of approved applications," Jia Jianxiong, the Deputy Head of the General Business Department of CMDE said.

Direct communication improving the efficiency of innovation review
An expert review system is adopted for the special review of innovative medical devices, and enterprises shall provide complete and sufficient application materials.

In terms of applications of foreign companies, there are fewer problems in the product materials and the approval rate is higher, but the number of applications is fewer. It is reported that there were 80 applications for the special reviews of foreign innovative medical devices, among which 26 applications were approved with the rate of 32.5% as of April 22, 2019.

The Implementation Event provides an opportunity for foreign medical device enterprises and CMDE to communicate and exchange face to face.

Experts in the field of the intellectual property presented the conditions and procedures that foreign enterprises apply for patents in China. Is it necessary to apply for innovative medical devices after the patent filing is completed in China? How can foreign-registered patents complete applications more quickly for medical devices in China? The experts responded to many doubts put forward by representatives of enterprises in detail.

The remote video review can allow applicants in other regions to explain innovation ideas and working principle of products to experts of the review teams in Beijing and to be questioned by experts in real time in the form of video communication. This approach facilitates communication and improves the accuracy and efficiency of innovation review. It is reported that the remote video review has been piloted in Zhejiang, Jiangsu, Shanghai and Guangdong since 2018, and successful experience has been obtained. Now, the same approach can be adopted for applications for imported innovative products.

Electronic application for medical device registration to be started soon
The electronic application for medical device registration and the special review of innovative medical devices are the key tasks of CMDE in 2019.

Provisions of the State Council for Online Government Services issued on April 30 specifies that the electronic signature shall have the legal force equal to the handwritten signature or the seal, and the electronic seal shall have the legal force equal to the real seal, which provides legal basis for the implementation of electronic application for medical device registration.

Applicants/registrants need to log in the eRPS system by using their CA certificates during electronic application. The channel for CA certificate application has been opened from May 10, and electronic declaration of medical devices is coming.

At the Event, Li Yaohua, the Head of Quality Control Department, CMDE introduced the technical guidance for electronic submission of Chinese medical device registration application and answered questions asked by representatives of enterprises.

"It is convenient for registration applicants to submit registration application materials in the form of electronic application, and the electronic application has many advantages, including easy carrying and saving of registration application materials, the clear list of materials and elements to be uploaded, and high efficiency of registration reception." Li Yaohua said. The electronic application is helpful to saving time for evaluation and approval and improving efficiency as it gets rid of the restriction on the transfer of paper materials, standardizes the registration procedures and records the whole process in a closed system.

The electronic application creates a new communication channel between enterprises and CMDE. The eRPS system can provide message, WeChat and e-mail notification services. Enterprises can also know the progress of project evaluation and approval and consult with CMDE through the related official WeChat account.

In terms of progress arrangement of electronic declaration concerned by enterprises, CMDE responded that the eRPS system would be started within the year and CMDE would give enterprises an interim period, in which both electronic application and paper application would be accepted.

Source: China Pharmaceutical News