The medical device registrant system is fully implemented and the industry "dividends" are gradually released

Medical Network, July 22, 2021 "National Medical Device Safety Publicity Week" has been officially launched, as one of the important activities of the publicity week-"Medical Device Registrant System Seminar" was held in Beijing on July 20
.
At the meeting, the reporter learned that after the trial of the medical device registrant system kicked off in the Shanghai Free Trade Zone, Guangdong and Tianjin followed closely.
With the further expansion of the pilot work, it has covered 22 provinces (regions, cities).
), a number of gratifying results have entered the market one after another
.
According to available data, as of the end of May 2021, 1,377 products with a total of 227 registrants have been approved for listing in accordance with the pilot medical device registrant system
.
Compared with the 93 products at the end of 2019, the number has increased by nearly 15 times; compared with the 552 products in September 2020, the number has increased by nearly 150%
.
This means that the pilot work of the medical device registrant system has achieved initial results
.
Wang Lanming, the inspector of the Device Registration Department of the State Drug Administration, said: “The next step is that the medical device registrant system will be fully implemented nationwide in accordance with the newly revised Regulations on the Supervision and Administration of Medical Devices, and will continue to be improved
.
” The
　　pilot program was expanded to 22 provinces.

In fact, the concept of registrant and filing person has been proposed in the 2014 version of "Regulations on the Supervision and Administration of Medical Devices", but in addition to innovative medical device products, the management model of "bundling" product registration and production licenses in the same subject is still implemented
.
This management model is conducive to the pertinence and convenience of supervision, but with the continuous innovation and development of the medical device industry, the continuous deepening of socialized production, and the continuous refinement of social division of labor, this model has gradually revealed its limitations
.
The medical device registrant system has moved from "bundling" to "relaxing"
.
Yang Yue, a professor at the School of Pharmacy of Tsinghua University, pointed out that the newly revised "Regulations on the Supervision and Administration of Medical Devices" establishes the two core contents of the medical device registrant and filing system: Carry out quality management throughout the life cycle, and assume responsibility for the safety and effectiveness of medical devices in the entire process of research and development, production, operation, and use; second, it is clear that the entrusted manufacturing enterprise shall comply with laws and regulations , medical device production quality management standards, Mandatory standards , product technical requirements and commission agreements organize production, be responsible for production behavior, and accept the supervision of the commissioning party
.
Yuan Peng, Director of the First Division of the Device Registration Department of the State Drug Administration, said: “Currently, the 22 provinces in the pilot program have successful cases of registrants or entrusted manufacturers participating in the pilot program, but the situation in each province is different.
Some provinces There are many registrants, and most provinces are trusted enterprises
.
” According to the data, the top eight provinces (regions and cities) in terms of registrants are Hunan, Shanghai, Chongqing, Jiangsu, Zhejiang, Guangdong, Beijing and Tianjin
.
The top eight provinces (autonomous regions and municipalities) with the number of entrusted production enterprises are Hunan, Chongqing, Jiangsu, Shanghai, Guangdong, Anhui, Zhejiang and Tianjin
.
According to product type statistics, in vitro diagnostic reagents account for the most, accounting for 65%, passive 20%, and active 15%; in terms of product management category, the second category of medical devices is the majority, accounting for 92%, and the third category of medical devices accounts for 8 %
.
According to whether the statistics are cross-provincial, 85% of the pilots within the province and 15% of the cross-provincial pilots; according to the type of registration, change registration accounts for 74%, and first registration accounts for 26%
.
In addition, among the successfully piloted varieties, 649 products were commissioned within the group, 728 were not within the group, and the proportion of registrants within the Yangtze River Delta region (Shanghai, Jiangsu, Zhejiang, Anhui) that successfully piloted the group accounted for 76% of the total.
The proportion of successful pilots in provincial registrant groups accounts for 80% of the total number of pilots, which fully reflects the advantages of the registrant system in promoting the optimization and integration of group resources
.
From the point of view of the areas where the pilot was first launched, up to now, there have been 41 second-class products approved by 27 companies in Shanghai as the first registration, and 112 second-class products from 12 companies have been approved for registration changes
.
The variety covers medical devices and in vitro diagnostic reagents
.
The production methods cover different situations such as intra-group consignment, regional, cross-regional, and cross-provincial consignment
.
Among them, the inter-provincial commissioned production involved 59 products from 6 companies
.


What experience has been learned from the pilot program of 　　increasing the registrant registration system for intellectual property protection ? Yang Yue believes that the first is the quality management model
.
The registrant and the entrusted production enterprise respectively stipulated the corresponding conditions and obligations, clarifying that the two parties should sign the entrustment contract and the quality agreement; second, the licensing and modification procedures
.
Provisions are made for the procedures for product registration, change and production enterprise licenses; third, full life cycle management
.
Drug regulatory authorities at all levels should strengthen the supervision and management of registrants' obligations to ensure the quality of medical devices, market sales and services, monitoring and evaluation of medical device adverse events, and medical device recalls; fourth, entrust production of cross-regional regulatory innovation
.
Relevant provincial drug regulatory agencies shall, on the basis of coordination and unanimity, determine the division of responsibilities of all parties in cross-regional supervision, implement the main body of daily supervision responsibility, and ensure that there is no gap in the supervision of the entire life cycle and the entire chain of medical devices
.
According to Wu Yi from the Shanghai Municipal Drug Administration, “Through the pilot program, we believe that the implementation of the registrant system will enable relevant institutions with R&D capabilities to boldly innovate.
After obtaining the registration certificate, it is not necessary to invest a large amount of capital to organize production.
Registrant cooperation can make up for the lack of innovation and R&D motivation
.
Competent scientific research institutions can also join in and participate in the optimization of market factors
.
” Yuan Peng emphasized that the registrant system is not a simple commissioned production.
Clear division of powers and responsibilities between the two parties and the trustee
.
He reminded that the relevant work time limit should be implemented in strict accordance with the relevant documents; products that belong to the list of medical devices that are prohibited from being commissioned by the drug regulatory department must not be commissioned; the manufacture of entrusted medical devices must not be transferred again; medical devices produced in China, If a domestic applicant or filing person applies for registration or filing, and obtains a registration certificate or completes the filing, it becomes a medical device registrant or filing person
.
Based on the Shanghai pilot experience, Wu Yi suggested that the registrant should focus on ensuring the stable and controllable operation of the established quality system, continuously strengthening the dynamic management of entrusted companies, and strictly controlling the release of products to market
.
If the entrusted company focuses on changes in the production license conditions, it shall promptly conduct information exchange and evaluation and confirmation of the registrant, strengthen the continuous improvement of the production quality management system, especially the training of regulations for key positions, and assist the registrant in implementing product random inspections and defects.
event monitoring, quality disposal work
.
Yang Yue also suggested that by advancing the construction of "Internet + supervision", unifying inspection systems and standards, sharing enterprise rectification and inspection results, and gradually realizing cross-regional mutual recognition of inspection results
.
Regarding the issue of intellectual property protection, many companies suggested that more specific provisions should be made for the review of intellectual property protection in the supporting documents related to the registrant system issued subsequently
.
Wang Xinbing, director of regulations of Shenzhen Mindray Technology Co.
, Ltd.
, explained that in the implementation of the registrant system, it is bound to require the registrant and the entrusting company to fully share technical and process documents including R&D and production, which may result in CDMO business.
The risk of intellectual property infringement, especially when the CDMO platform itself is also a medical device R&D and production enterprise with its own brand rather than a professional foundry method
.
Especially with the implementation of the registrant system across provinces across the country, the protection of intellectual property rights has become particularly important during the registration process.
It is recommended that the regulatory authorities focus on the protection of intellectual property rights
.
State Drug Administration Device Registration Division, Device Supervision Division, assessment centers, Verification Center, an examination center, where the provincial bureau, trade associations, more than 10 enterprises to participate in this seminar
.