Brief introduction to the system of registrants:

　　Listing Licensor（Marketing Authorization Holder，MAH）systemIt refers to the management mode of separating marketing license from production license. Under this mechanism,Listing permissionandProduction licenseIt is independent of each other. The marketing license holder can entrust the products to different manufacturers for production. The safety, effectiveness and quality controllability of the products are the responsibility of the marketing license holder to the public. It is a system in line with the world and has certain institutional advantages. It can alleviate the problems under the current bundling management mode to a certain extent and improve the enthusiasm of new product research and development, Promote the prosperity of commissioned production, so as to promote the rapid development of China's medical industry.

　　Advantages:

　　The system of medical device registrant is to separate the original registration holder and production license holder as the same company entity mode to two different company entities. It has created opportunities for many scientific research institutions with R & D capacity and no production conditions.

　　Responsibilities of the registrant:

　　It is worth noting that on October 31, the general office of the State Food and Drug Administration publicly solicited opinions on the amendment to the regulations on the supervision and administration of medical devices (Draft). The draft for comments adds 8 articles and modifies 19 articles to the current regulations.

　　Among them, the amendments include improving the system of medical device marketing license holders. In the second chapter; Registration and filing of medical device products; There is a special article in the article to stipulate the conditions and specific obligations of the registrant and the record holder.

　　Similarly, the "plan" puts forward clear requirements for the registrant in terms of condition setting and ability evaluation, and also stipulates that the registrant of medical devices must have the ability to manage the whole life cycle of the listed medical devices, such as the design and development of medical devices, clinical trials, production and manufacturing, sales and distribution, after-sales service, product recall, product quality control, etc The adverse event report shall bear all legal responsibilities.

　　This means that whether the product is self production or commissioned production, the registrant should bear the main responsibility as the marketing license holder and fulfill the obligations in the whole product life cycle.

　　Regulatory authoritiesStrict control：

　　An entrustment contract and a quality agreement must be signed between the registrant and the entrusted enterprise.

　　This puts forward higher requirements for both registrant and entrusted enterprise, because the change of mode from internal handover to external transfer makes both enterprises need to clearly implement management responsibility in internal technology transfer system, legal liability provisions of both parties, and production quality responsibility of the trustee.

　　Judging from the plan published at present, there are more stringent requirements for supervision.

　　On the one hand, the management of the client itself requires the client to actively report the adverse events of medical devices and establish a traceability system. On the other hand, we should strengthen cross regional supervision and post IPO supervision, and introduce a third-party collaborative management, so as not to give speculators or zombie companies the opportunity to exploit loopholes.

　　Services provided by Huaguang Taihe company:

　　Huaguang Taihe can provide consulting services for medical device enterprises in terms of global multinational quality management system (ISO13485, qsr820, MDR, etc.), medical device production quality management specification (active, passive, sterile, implantation, IVD), etc., and assist enterprises to sort out & lt; Comprehensive management - R & D - Registration (registrant client) - commissioned production (registrant client) / production - quality - sales and after sales & quot; To help domestic / foreign medical device manufacturers identify the requirements of domestic medical device production quality management standards, integrate them into their own quality management system, and lay a solid foundation for the whole life cycle management of products.

　　Whether it comes from the domestic drug regulatory department system reform or regulation adjustment, now enterprises need to accept more and more inspection, the pressure of sustainable development is increasing, and the management risk is becoming very complex. In this case, our long-term follow-up counseling service can effectively help you manage the risks caused by the operation of the quality system. We can help you ensure compliance with regulatory requirements. Or need some specific services to meet your business requirements, our professional consultants are dedicated to help you. Through the cooperation with Huaguang Taihe to develop service plan, you can effectively protect the company's brand, improve trust and gain more recognition from relevant parties.

　　Service content:

　　1、Regular system, laws and regulations (including newly promulgated or revised laws and regulations) and skill training, standardize training management and form records;

　　2、Annual internal audit and on-site audit of management review, and standardize audit records and audit documents;

　　3、The administrative supervision department, the third party audit unqualified rectification, and standardize the management, form records;

　　4、Daily supervision and inspection, urge the enterprise to carry out the work according to the established procedure requirements, and form records for filing;

　　5、Report the information required by the regulatory authorities (including self inspection report), and communicate with the regulatory authorities.