First, get information.
Second, the preliminary judgment of project feasibility.
Third, first understand the project guide, list the materials that need to be prepared, convene a meeting of relevant departments, and coordinate the work content and time.
Fourth, prepare information.
Fifth, pay attention to the publicity of related websites.
6. Successful application-project establishment-kick-off meeting-communicate with the scientific research and financial departments in details, and submit financial data and interim report on scientific research progress in time.
Eight, project acceptance-scientific research and financial preparation audit materials.
IX. Conclusion-Reward relevant personnel-Archive information.
Expand knowledge:
Project declaration refers to a series of preferential policies formulated by government agencies for enterprises or other research units. Enterprises or related research units prepare declaration documents according to government policies, and then declare them according to relevant declaration requirements and procedures.
The projects that can be applied include the national provincial and municipal funding plan system and the funding plans of various ministries, such as the 863 Plan and the 973 Plan, the SME Innovation Fund, the SME Development Special Fund, the new technology of enterprises, the national social science fund, the national self-funded fund, the provincial social science fund, the provincial self-funded fund and other projects at different levels. The difficulty of application is different, and the qualifications and conditions of applicants are different.
References:
Science and Technology Project _ Baidu Encyclopedia
The basic conditions for intelligent manufacturing declaration are as follows:
(1) The project implementation unit is legally registered in Guangdong Province, has the qualification of an independent enterprise legal person, and is in good operating and financial condition.
(two) the technology of the project is at the leading domestic or international level, and the equipment and systems used in the demonstration project are independent, safe and controllable.
(3) The project meets the specific requirements of the corresponding category in the Guangdong Intelligent Manufacturing Pilot Demonstration Project.
(4) The project has achieved remarkable results in reducing operating costs, shortening product development cycle, improving production efficiency, reducing defective products, and improving the utilization rate of energy resources, and has continued to improve, with good growth.
(V) The project intelligent manufacturing mode has demonstration significance and popularization value in the whole industry, and the project unit is willing to actively cooperate with summing up experience and popularizing the mode.
(six) the project has been completed or basically completed, and achieved remarkable results. Unfinished projects should be completed before February 65438+2020.
How to register wearable products and medical devices?
Wearable medical devices, as a kind of medical devices, are not much different from ordinary medical devices in the process of registration and declaration. Here is a brief introduction to the application process and the problems that need everyone's attention.
1
classify
Medical device products can be classified by querying the classification catalogue first. If the product is not in the classified catalogue, it needs to be classified and defined on the website of China Food and Drug Inspection Institute to determine the product category. Classification is generally based on the working principle, structural composition and expected use of the product to determine the category, and will not change the category just because it is wearable.
However, it should be noted that the product may change its working principle, usage mode, product characteristics and so on. Because it is designed to be wearable, the product category changes. For example, traditional electronic thermometers and sphygmomanometers are classified as 6820 common diagnostic instruments, while wearable products are often classified as 682 1 medical electronic equipment because their functions are monitoring and their data are dynamic or continuous, which leads to changes in the expected use of their products.
2
Registration detection
After determining the product category, you can start the product registration test. Registration test needs to apply for registration test according to the actual situation of medical devices, and generally needs to provide product prototype, product technical requirements, instructions and labels. If there is software in the product structure, but the hardware for loading the software is not in the structural structure, it is necessary to provide hardware facilities to support the operation of the software, such as platforms, mobile phones and computers. To meet their special requirements, these equipment will be inspected as an attachment to the test.
At the same time, because wearable medical devices are often in contact with human body for a long time, biological experiments commissioned by testing should be considered in biocompatibility research. Please refer to GB/T16886.1-2011for specific items, which belongs to entrusted testing.
three
Clinical evaluation
For Class II and Class III medical devices, clinical evaluation is required during registration and application, and wearable medical devices are no exception. According to the requirements of the Technical Guiding Principles for Clinical Evaluation of Medical Devices and the actual situation of the products, the methods of clinical evaluation are selected: applying for exemption from clinical trials, obtaining data from clinical trials of the same variety of medical devices or conducting clinical trials. It should be noted that for the products that want to apply for clinical exemption, even if they meet the requirements in the clinical exemption catalogue, it is necessary to submit a comparative description of the declared products and the medical devices that have been approved for domestic registration in the catalogue.
Comparison Table of Products Declared in Catalogue and Medical Devices Approved for Domestic Registration
Contrast project
Medical devices in the catalogue
Declared product
different
supportive
Data overview
Basic principle (working principle/action mechanism)
Structural composition
Manufacturing materials of products or parts in contact with human body.
Performance requirements
Sterilization/disinfection mode
application area
Application mode
four
Submit registration approval and system evaluation.
When submitting the registration approval, the framework of registration materials submitted as wearable medical device products is no different from other products, and it is still twelve main parts. We will further discuss the specific application requirements of the application materials with you in future articles, so stay tuned.
Ministry of Science and Technology: "Intelligent Robots" and other key special declaration guidelines issued.
A few days ago, the website of the Ministry of Science and Technology published the "Guidelines for the Application of National Key R&D Projects in 20 19" (referred to as the application guidelines). The application guide shows that six key projects, including "intelligent robots", involve a total estimated budget of about 2.26 billion yuan. Among them, the total budget of the key project of "Intelligent Robot" is about 400 million yuan, the key project of "Research and Development and Application Demonstration of Key Technologies in Modern Service Industry" is about 300 million yuan, the key project of "Integrated Transportation and Intelligent Transportation" is 65.438+0.7 billion yuan, the key project of "Network Collaborative Manufacturing and Smart Factory" is 680 million yuan, and the key project of "Manufacturing Basic Technology and Key Parts" is 450 million yuan.
The key project of "intelligent robot" is deployed and implemented in six directions from four levels: basic frontier technology of intelligent robot, new generation robot, key technology, industrial robot, service robot and special robot. No less than 33 projects will be launched in 20 19.
The key project of "Research, Development and Application Demonstration of Key Technologies in Modern Service Industry" is planned to set up 20 research directions and arrange no less than 20 projects in 20 19 according to the five directions of modern service industry theory and key core technologies and the demonstration categories of key technologies and applications.
In the key special project of "Integrated Transportation and Intelligent Transportation", the key research tasks are deployed in six technical directions: intelligent transportation infrastructure, intelligent coordination of vehicles and supervision and coordination of traffic operation 15. In 20 19, it is planned to start four 6- 12 projects with technical directions.
In 20 19, the key project of "networked collaborative manufacturing and smart factory" is planned to start at least 38 projects around the core industrial software of manufacturing industry, key technologies and solutions of smart factory, networked collaborative manufacturing platform of manufacturing enterprises, integrated technology and application demonstration, etc.
The key project of "Manufacturing Basic Technology and Key Parts" is deployed and implemented in five directions: key basic parts, basic manufacturing technology, advanced sensors, high-end instruments and meters, and basic technical support. No less than 28 projects are planned to be launched in 20 19.
In 20 19, the key project "internet of things and key technologies and demonstrations of smart cities" will start the research task of 1 1, with the main goal of promoting the demonstration and innovation of integrated applications of smart cities and forming core key technology solutions.
What are the requirements for the major scientific and technological projects of "New Generation Artificial Intelligence" in the key areas of R&D plan?
(1) If the applicant is an innovative entity registered in Guangdong Province (including enterprises, research institutes, universities, other institutions and industry organizations, etc.). ), Industry-University-Research should pay attention to combining and integrating superior resources inside and outside the province; If the applicant is an institution of higher learning in Hong Kong and Macao, it shall be included in the corresponding scope in accordance with the spirit of the document "Several Provisions of Guangdong Provincial Department of Science and Technology and Guangdong Provincial Department of Finance on the Participation of Institutions of Higher Learning and Scientific Research in Guangdong Financial Science and Technology Plan (Special Projects, Funds, etc.)". ) "(Yue Ke Biao Zi [20 19]No. 1); If the applicant is a unit outside the province, the project approval process shall be treated equally with units in Guangdong Province in accordance with relevant regulations.
Units outside the province take the lead in reporting, and after competitive evaluation, they are selected and included in the management of science and technology plan project library; The warehousing project will be supported after meeting the conditions of scientific research institutions, scientific research activities, major teams landing in Guangdong, project intellectual property declaration in Guangdong, and project achievements transformation in Guangdong.
(2) Adhere to demand orientation and application orientation. Industry-University-Research is encouraged to make joint declaration. If the lead applicant is an enterprise, in principle, it should be a high-tech enterprise or a leading backbone enterprise, with R&D institutions and a national, provincial and ministerial-level major innovation platform in this field, with the leading figures in this field as the project leader. Encourage the increase of matching capital investment, enterprises take the lead in reporting, and the self-raised funds in the total investment of the project are not less than 70% in principle; Non-enterprise declaration, the total investment of self-raised projects in principle is not less than 50% (self-raised funds are mainly funded by enterprises participating in the declaration). (three) the reporting units of R&D projects in key areas in the province are generally not limited by the number of projects under research. The project should rely on innovative units with significant advantages in this field, strengthen the overall planning and factor integration of theft, and concentrate on technical research. Do not encourage the same unit or the same research team to disperse their efforts and take the lead in the same special project and participate in the declaration of multiple projects, otherwise it will be included in the scientific research integrity record and dealt with accordingly.
(four) the person in charge of the project should play an overall leadership role, can participate in the organization and implementation of the project, and prevent the phenomenon that high-end well-known experts in the field are named.
(five) the content of the project must be true and credible, and shall not exaggerate its own strength and technical and economic indicators. All reporting units should be responsible for the authenticity of the application materials, implement the requirements of "Several Opinions on Further Strengthening the Construction of Scientific Research Integrity" (20 18), strengthen the examination and control of the application materials, and prevent exaggeration or even fraud. All reporting units and project leaders shall sign a letter of commitment on the authenticity of the reporting materials (the template can be downloaded from the Sunshine Government Platform System and must be stamped with the official seal of the unit). Once the project is confirmed, the technical, product, economic and other assessment indicators shall not be modified or adjusted without justifiable reasons.
(six) the reporting unit should conscientiously do a good job in the budget, truthfully declare, and should meet the relevant requirements of the declaration guide.
(seven) in any of the following circumstances, the person in charge of the project or the applicant shall not declare or pass the qualification examination:
1. The person in charge of the project has more than 3 (including 3) unfinished projects of Guangdong Science and Technology Plan or projects overdue for more than 1 year (excluding platforms, general policies and post-subsidy projects);
2. The person in charge of the project has not completed the acceptance of major science and technology projects and key R&D projects in Guangdong Province (in this case, the person in charge can still participate in the project declaration as the main participant);
3 major violations found in the process of audit and inspection of provincial special funds;
4. Repeated declaration of the same project or repeated declaration by changing the name of the subject;
5. The main contents of the project have been declared by the unit alone or jointly with other units and approved by the provincial science and technology plan;
Six units in the province have not been recommended by the competent department of science and technology;
7. During the execution of discipline, there are records of serious dishonesty in scientific research and "blacklist" records of credit in related social fields;
8. Violation of scientific research ethics.
(eight) to declare the project must also meet the specific declaration conditions in the declaration guide.
An application process for science and technology projects, including, for example, application, acceptance, project establishment, etc. There is also the general process of patent application.
Science and technology project application process:
1. The reporting unit prepares the project declaration and related materials according to the scientific and technological project guide;
2, the declaration submitted by the reporting unit and related materials;
3. The Science and Technology Bureau organizes relevant experts to review the declared projects;
4, the project unit and the Science and Technology Bureau signed the project task book;
5, the project implementation unit in accordance with the requirements of the task book to organize the implementation;
6, after the completion of the project, the project implementation unit to submit the project acceptance summary report;
7. The Science and Technology Bureau organizes the acceptance of the implementation project.
Patent application process:
(1) An application for a patent for invention
1. Approval process of invention patent application: patent application-acceptance-preliminary examination-publication-substantive examination request-substantive examination-authorization.
2. Documents to be submitted when applying for an invention patent: 1) Request: including the name of the invention patent, the name of the inventor or designer, the name and address of the applicant, etc. 2) Description: including the name, technical field, background technology, invention content, attached drawings and specific implementation methods of the invention patent.
3) Claim: Explain the technical features of the invention, and clearly and concisely state the content to be protected. 4) Drawings in the specification: Invention patents often have drawings. If only words can describe the technical scheme clearly and completely, there is no need for drawings.
(2) An application for a patent for utility model
1. Approval process of utility model patent application: patent application-acceptance-preliminary examination-announcement-authorization.
2. Documents to be submitted when applying for a patent for utility model: 1) Request: including the name of the patent for utility model, the name of the inventor or designer, the name and address of the applicant, etc. 2) Description: including the name, technical field, background technology, invention content, drawings and specific implementation of the utility model patent.
The contents of the manual should be written in detail, and the technical contents mentioned shall be subject to the realization after reading by ordinary technicians in this technical field. 3) Claim: Explain the technical features of the utility model, and clearly and concisely state the contents of the requested protection.
4) Illustration: The patent for utility model must have attached drawings. 5) Description summary: clearly reflect the technical problem to be solved by the invention, the main points and main uses of the technical scheme to solve this problem.
(3) An application for a patent for appearance
1. Process of applying for a patent for appearance: patent application-acceptance-preliminary examination-announcement-authorization.
2. Documents to be submitted for the design patent: 1) Request: including the name of the design patent, the name of the designer, the name and address of the applicant, etc. Design pictures or photos: at least two groups of pictures or photos (front view, back view, top view, bottom view, left view, right view and, if necessary, stereoscopic view) Brief description of design: Brief description of design shall be submitted if necessary.
Extended data:
Patent application: An invention-creation must be submitted by the applicant to the competent government departments (in China, it refers to People's Republic of China (PRC) and China National Intellectual Property Administration), and the patent right can only be obtained after being approved by People's Republic of China (PRC) and China National Intellectual Property Administration according to legal procedures.
In China, inventions include three types, namely inventions, utility models and designs. In the application stage, they are called application for invention patent, application for utility model patent and application for design patent respectively. After being authorized, they are called invention patent, utility model patent and design patent respectively. At this point, the applicant is the patentee of the corresponding patent.
References:
China National Intellectual Property Administration Renshou County People's Government Science and Technology Project Declaration-Patent Application Approval Flowchart