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医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
开办医疗器械店铺流程英文回答：Step 1: Determine the Type of Medical Device Business.Decide on the specific medical devices you will sell, such as medical equipment, consumables, or diagnostic tools.Consider the target market and their specific needs.Research the regulatory requirements and industry standards for your chosen medical devices.Step 2: Obtain Legal and Regulatory Permits.Register your business with the appropriate authorities, such as the FDA or other regulatory bodies.Obtain any necessary licenses and permits to operate a medical device business.Comply with zoning regulations and building codes for your business premises.Step 3: Secure Funding.Determine the startup costs for your business, including equipment, inventory, and operating expenses.Explore various financing options, such as loans, grants, or investors.Create a solid business plan to present to potential investors or lenders.Step 4: Find a Suitable Location.Choose a location that is accessible to your target market.Consider factors such as visibility, parking, and proximity to medical facilities.Ensure that your chosen location meets the regulatory requirements for medical device storage and distribution.Step 5: Acquire Inventory.Establish relationships with reputable medical device suppliers.Negotiate favorable pricing and delivery terms.Maintain an adequate inventory to meet demand while minimizing waste.Implement proper inventory management systems to track stock levels and ensure efficient replenishment.Step 6: Develop Marketing and Sales Strategies.Create a comprehensive marketing plan to reach your target audience.Utilize channels such as online advertising, social media, and industry events.Implement effective sales strategies to generate leads and convert prospects into customers.Provide excellent customer service to build long-term relationships.Step 7: Ensure Compliance and Quality Control.Adhere strictly to regulatory standards and industry best practices.Implement quality control measures to ensure the safety and efficacy of your medical devices.Maintain traceability and documentation for all products sold.Seek certification or accreditation to demonstrate your commitment to quality.中文回答：开办医疗器械店铺流程：第一步，确定医疗器械业务类型。
注册小规模医疗器械公司的流程Registering a small-scale medical device company can be a complex and challenging process, but with the right guidance and knowledge, it is definitely achievable. Thefirst step in this process is to conduct thorough research on the regulations and requirements set forth by therelevant regulatory authorities in your country. This will provide you with a clear understanding of what is expectedof you and will help you plan and prepare accordingly. Itis important to note that the regulations and requirements may vary from country to country, so it is crucial to bewell-informed about the specific regulations in your region.Once you have a solid understanding of the regulations and requirements, the next step is to develop a comprehensive business plan for your medical device company. This plan should outline your company's goals, target market, product offerings, marketing strategies, and financial projections. A well-thought-out business planwill not only serve as a roadmap for your company's future,but it will also be required when applying for various licenses and permits.After developing a business plan, the next step is to choose a suitable business structure for your company. This decision will have legal and financial implications, so it is important to carefully consider the pros and cons of each business structure. Common options include sole proprietorship, partnership, limited liability company (LLC), and corporation. Each structure has its own set of requirements and regulations, so it is essential to choose the one that best aligns with your company's goals and needs.Once you have chosen a business structure, the next step is to register your company with the appropriate government authorities. This typically involves obtaining a business license, tax identification number, and any other necessary permits. The specific requirements forregistering a medical device company will depend on the regulations in your region, so it is important to consult with a legal professional or business advisor to ensurethat you are meeting all the necessary requirements.In addition to registering your company with the government, you will also need to obtain the necessary certifications and approvals for your medical devices. This may include obtaining a quality management system certification, such as ISO 13485, and obtaining clearance or approval from the relevant regulatory authorities for each of your medical devices. The process for obtaining these certifications and approvals can be lengthy and complex, so it is important to start this process early and seek guidance from experts in the field.Finally, it is important to establish strong relationships with suppliers, distributors, and other industry partners to ensure the success of your medical device company. Building a network of reliable and reputable partners will not only help you bring your products to market, but it will also provide valuable support and resources as you navigate the regulatory landscape. By following these steps and seeking guidance from experienced professionals, you can successfullyregister a small-scale medical device company and position it for long-term success in the industry.。
开医疗公司的流程Starting a medical company can be a challenging yet rewarding endeavor. First and foremost, it is important to have a clear vision and mission for the company. 创办一家医疗公司可能是一个具有挑战性但有益的事业。
首要的是，公司需要有清晰的愿景和使命。
The process of starting a medical company involves several key steps. It is important to conduct thorough research and market analysis to understand the demand for medical services in the target area. 开办医疗公司的过程包括几个关键步骤。
进行彻底的研究和市场分析是非常重要的，以了解目标地区对医疗服务的需求。
One crucial aspect of starting a medical company is obtaining the necessary licenses and certifications. This may involve navigating through complex regulations and compliance requirements set by government agencies. 创办医疗公司的一个至关重要的方面是获得必要的许可证和认证。
这可能涉及通过政府机构设定的复杂法规和合规要求。
Another important consideration is the financial aspect of the business. Securing funding and establishing a sound financialstructure are vital for the success and sustainability of the medical company. 另一个重要考虑因素是企业的财务方面。
国家食品药品监督管理局令第16号《医疗器械注册管理办法》于2004年5月28日经国家食品药品监督管理局局务会审议通过，现予公布，自公布之日起施行。
局长郑筱萸二００四年八月九日医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.These Measures have been formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration on the medical device registration and ensure the safety and efficiency of medical devices第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.The medical devices sold and used in the territory of the People’s Republic of China must be registered according to the provisions of these Measures; no medical appliance without registration will be allowed to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
开办医疗器械店铺流程Starting a medical equipment store can be a rewarding venture for those interested in helping others access essential healthcare supplies. However, it is crucial to navigate through various steps to ensure the success and legality of the business.开办医疗器械店可能是一个有益的事业，对那些希望帮助他人获得基本医疗保健用品的人来说。
然而，需要通过各种步骤来确保业务的成功和合法性。
First and foremost, research the market to understand the demand for medical equipment in your area. This will help you determine the types of products to stock and the target audience to cater to. Conducting market research can also provide insights into your competition and potential challenges you may face.首先，要研究市场，了解当地对医疗器械的需求。
这将帮助您确定需要存货的产品类型和目标受众。
进行市场调研还可以帮助您了解竞争对手和潜在挑战。
Next, create a detailed business plan outlining your store's mission, vision, target market, marketing strategies, and financial projections.A well-thought-out business plan is essential for securing funding from investors or financial institutions and guiding your business operations in the right direction.接下来，制定一份详细的业务计划，概述您店铺的使命、愿景、目标市场、营销策略和财务预测。
医疗器械二类经营企业备案流程(中英文实用版)Title: The Registration Process for Class II Medical Device Operating Enterprises中文标题：医疗器械二类经营企业备案流程---Firstly, it is essential for the enterprise to understand the specific requirements and regulations set forth by the relevant local and national authorities.首先，企业必须了解当地和国家相关部门制定的具体要求和规定。
---Subsequently, the enterprise must prepare the necessary documentation, which typically includes identification documents of the legal representative, the enterprise registration certificate, and a detailed description of the medical devices to be managed.接下来，企业必须准备必要的文件，通常包括法定代表人身份证件、企业营业执照以及将要管理的医疗器械的详细描述。
---After gathering all the required documents, the enterprise should submit the application to the local food and drug regulatory authority for review.在收集所有必需的文件后，企业应将申请提交给当地食品药品监管部门进行审查。
---Once the application is approved, the enterprise will be issued a Class II medical device operating permit, which is valid for a certain period.一旦申请获得批准，企业将获得有效期一定的二类医疗器械经营许可证。
中英文对照翻译Present status and problems of domestic medical instrument engineering. Biomedical EngineehngIn recent years considerable progress has been achieved in domestic medical instrument engineering. Many plants and scientific-research organizations of machine-making and the defense industry have changed their profile toward production of medical equipment.However, medical equipment often meets a reluctant market because of funding cuts in health services. Medical organizations often cannot satisfy even their basic requirements for diagnostic and therapeutic devices. Also, health service organizations tend to buy foreign rather than domestic medical equipment because the former are easily available on the domestic market and prices for both are comparable because of inflation.The transition to a market economy in Russia has had substantial impact on the relations between domestic manufactur- ers and consumers of medical devices. The spectrum and quality of available items has been significantly extended in recent years. It should be also noted that available models of medical devices are continuously updated, which makes them sufficiently competitive.Representative information on the updating dynamics of domestic medical equipment is summarized in Table 1. The data were provided by the VNIIMP-VITA Joint-Stock Company, which compiles a data bank of such information.Generally, new items account for 37% of total production of medical devices. Routinely produced devices (duration of production, 2-5 years) account for 28%. Medical devices of long-term production (5-10 years) account for 17% and obsolete nomenclature (devices produced for more than 10 years) accounts for 18%.It is seen from Table 1 that in recent years there has been considerable progress in the updating of production of medical equipment. For example, according to the VNIIMP-VITAJoint-Stock Company, the share of the items that have been produced for no longer than 5 years in 1988 did not exceed 35%, while now it is 65%. For the items that have been produced for more than 10 years such shares are 40 and 18%, respectively.Updating of produced medical devices was encouraged by the increase in the number of designers and manufacturers, particularly those of former defense industry facilities. In collaboration with foreign partners they set up joint ventures for producing medical equipment.Analysis of the updating of the various groups of medical equipment is of substantial interest.It is seen from Table 1 that detoxication devices contribute dominantly to the group of items that have been updated within the standard period of up to 5 years (100% of production, including modern devices for hemodialysis and hemosorption).Comparatively high updating indices are observed for devices for functional diagnosis: 72% of these devices have been produced for no longer than 5 years, and obsolete devices account for only 9% of total production. However, it should be noted that although production of some obsolete devices has been terminated, equipment of similar functional capacity is still urgently needed.Relatively low updating indices are observed among the devices for intensive care and resuscitation: 16% of new items and comparatively many obsolete devices (26%). Among new models apparatuses for artificial lung ventilation are worth mention. However, some apparatuses, which have been developed long ago are still on the market because they have good performance, are quite reliable, and still are in demand. This reduces the updating index of the group as a whole.All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.0006-3398/96/3001-0001515.00 y Plenum Publishing CorporationTABLE 1. Updating of Basic Groups of Medical Devices and Apparatuses (% of total nomenclature)The lowest updating indices are observed for devices for examining a patient's body structures.These are: ophthalmological, otolaryngological, and anthropometric devices, endoscopes, etc. Theshare of obsolete devices is high (44%), while the devices which have been produced for no more than 5 years account for only 20% of total production.It should be noted that these results on medical equipment updating are important generalestimates, although they do not take into consideration specific achievements and shortcomings in the production of individual items. Therefore, some corresponding amendments are required.Our survey of available information, including the VNIIMP-VITA Joint-Stock Company data bank, materials presented at various exhibitions, and recent literature, shows that domestic medical industry has developed a number of original medical devices and apparatuses which were designed to replace similar obsolete models. However, many types of important and necessary medical devices still do not meet contemporary requirements, and some types of devices are not produced at all.For example, in recent years production of some sophisticated medical devices (apparatuses for intensive care, resuscitation, and anesthesiology; devices for artificial lung ventilation, respiratory narcosis devices, extracorporeal circulation) significantly rose, particularly at the former defense industry facilities, and their quality has been significantly improved. The functional performance of the devices is generally on par with foreign analogs.Perfusion units have also been improved and their production has expanded. This allowed the demand of the health service organizations for such equipment to be satisfied completely. Modern domestic hemodialysis devices (Renart-10, Renan- 10RT, etc.) have been developed and brought into wide clinical practice.The development and production of diagnostic magnetic resonance imaging systems (Obraz-3, TOROS) are considerable breakthroughs in domestic medical industry. This substantially extends diagnostic capacities of many health service organizations and provides them with topical diagnosis previously unavailable domestically, although it is quite common in developed foreign countries.Domestic medical industry has begun production of pulse oximeters; these are of particular use in surgery and resuscita-tion. This bridged a substantial gap in the spectrum of available domestic medical devices.The Bilitest bilirubin meter, which has been recently developed and produced in Russia, fully meets the requirements of maternity and children's hospitals in devices for diagnosing jaundice.A high-standard radioimmunochemical laboratory was opened at the VNIIMP-VITA Joint-Stock Company to supply customers with necessary radioimmunochemical assay kits.A number of high-quality medical devices and instruments have been developed at the electronic industry plants and institutes. The following devices are particularly worthy of mention artificial cardiac valves of the Emitron Plant, which are on par with the best foreign analogs;pH meters (Istok State Scientific-Manufacturing Association);Ikar long-term (up to 24 h) cardiomonitors with electronic memory (Kometa Central Scientific-Manufacturing Association);radiothermographs and racliothermoscopes for detecting deeply located thermal fields in the human body (Oktyabr' Manufacturing Association and Design Bureau for Ecological and Medical Equipment);original thermal imaging system (Institute of Radioelectronics and Automatics, Russian Academy of Sciences; OPTROS, Ltd.);original computer-assisted system Cardiac Rhythms for monitoring oatient condition and pulsimetry (Institute of Chemical Physics, Russian Academy of Sciences; Ekos, Ltd.);video system for endoscopic imaging (Zenit Scientific-Manufacturing A~sociation; Elektron Scientific-Research and Manufacturing Association);streamlined technology for producing disposable and reusable syringes, injection needles, and surgical threads.A number of other problems of domestic medical instrument-making industry have been successfully solved in recent years.For example, the number and quality of therapeutic devices, particularly for laser therapy, is quite sufficient. Research studies are carried out by many organizations including former defense industry facilities. Technologies which have been developed for other purposes give fruitful results in medical industry.According to our data, more than 150 models of such medical devices have been developed over the last 5 years. Some 100 of them are commercially available. Although domestic medical devices are often superior ot foreign analogs in terms of working performance and they are definitely less expensive, many of them are not in short demand and are virtually not used.However, this activity in many other areas of medical instrument engineering cannot be considered as sufficiently successful and rational.It should be noted that many newly developed models of domestic medical devices compare unfavorably with foreign analogs. This is particularly the case for X-ray and ultrasonic devices, electrocardiographic monitors, laboratory equipment, etc. Nevertheless, according to the VNIIMP-VITA Joint-Stock Company databank, certain positive trends have been observed in recent years even in these areas. However, most problems still remain unsettled and the conditions required to solve them have not yet been established.It is important to note that the serially produced X-ray apparatus RUM-20 (Mosrentgen Joint-Stock Company) has been significantly updated. The updated model RUM-20M-SG312 is commercially available in combination with the Sapfir domestic image intensifier or an image intensifier of a French manufacturer. The Kruiz fiat image intensifier has been developed at the All-Russian Scientific-Research Institute for Medical Instrument Engineering in collaboration with MELZ Manufacturing Association and Mosrentgen Joint-Stock Company. This device is designed to replace existing fluorescent screens in the X-ray diagnostic apparatuses RUM-10, RUM-20, RUM-20M, and others. The use of the Kruiz image intensifier significantly increases image information content and allows threefold decrease in the radiation load on patients and medical personnel.The G 202-5 system for lit-par-lit raster imaging of patients in lying position has been developed at the Mosrentgen Joint-Stock Company. This device is commercially available with the PURS power source. It allows both manual and automatic X-ray photography and organ-oriented X-ray examination.The RTS-61 mobile X-ray video diagnostic apparatus has been developed at the Elektron Scientific-Research and Manufacturing Association. This device is designed to be used in surgery, orthopedics, and traumatology. Among the defense industry facilities which have reoriented their production to medical market the Scientific-Research Institute for Electromechanics (Istra) is worth mention. In collaboration with Phillips (Germany) and borrowing their technology and circuitry, the Institute for Electromechanics developed the Mammodiagnost mammographic scanner, which meets international standards of operating performance.The Rentgen-48 X-ray tomographic diagnostic systems with a rotary support table and the Rentgen-60 X-ray diagnostic systems with a remote control support table have been developed at the Sevkavrentgen Plant and received positive recognition by practicing physicians.The models of X-ray diagnostic devices listed above are examples of achievements of domestic medical industry.However, many important and significant problems of the development of domestic medical X-ray equipment remain unsettled, and it is unreasonable to expect that they will be solved in the foreseeable future unless special measures are taken.For example, the most common RUM-20 X-ray apparatuses with the Sapfir image intensifier are equipped with the obsolete X-ray image converter REP-1. To replace the REP-1 image converter, the Moscow Plant for Electronic Tubes has developed the Buer image converter of improved design. This device offers better image contrast, reduced clark background noise, and has an output fiberoptic window of improved design. However, the Buer image converter is not yet commercially available.Digital X-ray diagnostic devices are not yet commercially available from domestic manufacturers either.The Design Bureau for Medical Engineering in collaboration with Medtekh, Ltd. (Novosibirsk) have developed the Diaskan X-ray digital scanner. Serial production of this device is in progress at the Design Bureau for Medical Engineering.However, devices of sufficient quality are not yet commercially available.Domestic medical industry does not produce X-ray tomographs. Their production in Chelyabinsk has been suspended.Electrocardiographic monitors are very important devices for functional diagnosis. However, domestic medical industry fails substantially behind leading foreign manufacturers and there is a disproportion in the development and production of necessary devices and apparatuses. Many automatic systems for ECG processing, including syndromal diagnosis, have been developed, but they trove not been tested and are of little demand. However, simple three-channel electrocardiographs of mass- scale application are not produced by domestic manufacturers.Foreign manufacturers offer various ultrasonic scanners and sophisticated imaging systems. Domestic manufacturers produce only simple devices with manual sector-by-sector scanning and a few simplified models with linear electronic scanning.Some positive results have been achieved in the development of endoscopic devices. These achievements are mainly due to the collaboration between LOMO and some companies from Japan. However, even these devices require further improvement of quality and reliability.Although the level of production of domestic laboratory equipment has noticeably risen in recent years, it is still too little to meet the demand. The number of organizations involved in the development of such equipment has risen. However, the available devices are simple and have limited functional capacity. Many important devices (e.g., automatic analyzers and simple routine devices) are not produced at all.Devices for blood transfusion and preparing blood substitute solutions are still in short supply (40 million items have been produced, while the demand is 200 million). The demand in dialyzers and polymer infusion systems reaches 100 and 150 million items, respectively, although such systems are not produced at all.The correspondence between production and demand, quality and technical performance, and adequate testing of medical production are put in the forefront under conditions of a market economy. The problem of competition with foreign manufacturers is also quite important because of increasing import of medical equipment and reduced sale of the production of domesticmanufacturers. In this connection, the following circumstances should be taken into consideration.There is a considerable disproportion between production and demand of some groups of medical devices. For example, there is :~ huge surplus of laser therapeutic devices and their excessive development. Systems for syndromal electrocardiographic diagnosis, magnetotherapy, and electrostimulation are also in excessive supply. However, simple electrocardiographs, routine laboratory equipment, and some other ordinary but necessary devices of mass-scale application are not produced by domestic manufacturers. These disadvantages cause significant economic losses and present difficulties in the development of health service. Domestic and foreign experience show that these problems can be solved by adequate marketing, but this is in its infancy in the domestic medical industry.It should be noted that foreign companies place special emphasis on marketing and market research. They evaluate actual and pending demand as well as consumer requirements. The feedback between consumer and manufacturer gives valuable information on the improvement of the product quality and working performance. The marketing service in most leading companies is of paramount importance. The development of a new product often starts from marketing survey rather than from engineering or design research. Many domestic organizations of medical instrument engineering require cardinal measures for increasing the level of marketing.Testing of medical devices also requires substantial improvement. Considerable experience of foreign manufacturers of medical equipment should be taken into account. It should be noted, however, that this experience is often neglected by domestic manufacturers. Technical testing of medical equipment in foreign companies is usually carried out by independent laboratories which assess performance and quality. The specialists of the laboratories may also give recommendations for further improvement of the tested equipment. The basic goal of the testing is to check if the performance of the device matches its specifications and to conclude if the device can be used in medical organizations. However, the specialists of the laboratories usually go beyond this goal and issue comparative reviews of products of different companies. Such reviews contain the following information: description of tested device, its specifications, and price; results of technical testing, correspondence between specifications and actual performance, advantages and disadvan- tages, recommendations for improvement (if necessary);comparative analysis of similar devices and apparatuses produced by different manufacturers. Such analysis is usually concluded by a most preferable model, which is recommended to medical organizations on the basis of functional capacity, reliability, and economic reasons.In the USA, activity of testing laboratories is controlled by governmental, nongovernmental, and independent nonprofit organizations.In Russia, the problem of balance between the demand in medical devices, their production by domestic manufacturers, and import is of considerable importance.The opinion of the Head of the Department of Medical Industry, Russian Ministry of Health and Medical Industry, Yu. F. Doshchitsin, which was published in the weekly "Meditsinskii Biznes" (No. 9, 1995), is that the requirements of Russian medical market must be met by domestic devices, including products of high technology. Russian medicine should not rely on imported devices alone. We certainly agree with this opinion.The total volume of medical equipment purchased from abroad is presently several times greater than purchases from domestic manufacturers. This situation is definitely unacceptable. Cardinal measures are required to boost and stimulate economically domestic manufacturers ofmedical equipment. This is particularly important for manufacturers of life support systems and devices for military medicine.However, positive aspects of contacts with foreign manufacturers of medical equipment should not be disregarded. International cooperation is very common in foreign practice, but it is clearly insufficient in Russia.International cooperation in medical industry is particularly vital in such areas as computer technology, microprocessors, and electronic engineering. Lack of sufficiently high-quality domestic computers and microprocessors presents considerable problems in the development of sophisticated medical devices and apparatuses.In recent years a number of domestic organizations established joint ventures with leading foreign manufacturers of medical devices. These joint ventures produce high-technology devices on the basis of imported circuitry, modules, and individual finished units. For example, VNIIMP-VITA produces ultrasonic doppler scanners, Kursk Manufacturing Association Pribor in collaboration with Frezenius (Germany) produces mobile apparatuses for hemodialysis and hemosorption, LOMO and some companies from Japan established a joint venture for manufacturing flexible endoscopes of improved design, Moscow Manufac- turing Association EMA produces ultrasonic diagnostic devices, etc.It seems reasonable to continue and extend mutually profitable contacts between domestic and foreign manufacturers of medical equipment.Active participation and patronage of the Russian Ministry of Health and Medical Industry as well as the Russian Government and local authorities are needed to solve the problems of medical industry listed above and to implement programs of development and production of high-quality domestic medical devices.References[1] V. A. Viktorov，V. P. gundarov，A. P. yurkevich. Present status and problems of domestic medical instrument engineering. Biomedical Engineehng~ V oL 30, No. 1, 1996.[2]All-Russian Scientific-Research Institute for Medical Instrument Engineering, Rusaian Academy of Medical Sciences (VNIIMP-VITA Joint-Stock Company), Moscow. Translated from Meditsinskaya Tekhnika, No. 1, pp. 4-9, January-February, 1996. Original article submitted August 23, 1995.国内医学仪器工程的现状和存在的问题近年来，国内在工程医疗器械实现取得了很大进展。
医疗器械注册管理办法欧阳光明（2021.03.07）Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemicevaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.四条国家对医疗器械实行分类注册管理。
注册小规模医疗器械公司的流程英文回答：Registering a small-scale medical device company involves several steps and processes. Here is a general overview of the process:1. Determine the type of medical device: Before registering the company, it is important to determine the type of medical device you plan to manufacture or distribute. This will help you understand the specific regulations and requirements that apply to your product.2. Conduct market research: It is crucial to conduct thorough market research to understand the demand for your medical device, potential competitors, and any specific regulations or certifications required in your target market.3. Develop a business plan: Create a comprehensivebusiness plan that outlines your company's goals, target market, marketing strategies, and financial projections. This will help you present a clear vision to potential investors or stakeholders.4. Choose a business structure: Decide on the legal structure of your company, such as a sole proprietorship, partnership, or limited liability company (LLC). Consult with a legal professional to understand the pros and cons of each structure and choose the one that best suits your needs.5. Register the company: Register your company with the appropriate government authorities. This typically involves submitting the necessary documents, such as the business plan, identification documents, and registration forms. Pay any required fees and obtain the necessary permits or licenses.6. Obtain necessary certifications: Depending on the type of medical device you plan to manufacture or distribute, you may need to obtain specific certificationsor approvals. For example, in the United States, medical devices are regulated by the Food and Drug Administration (FDA), and you may need to obtain FDA clearance or approval.7. Establish quality management systems: Implement quality management systems to ensure compliance with regulatory requirements and to maintain the safety and effectiveness of your medical devices. This may involve developing standard operating procedures, conductingregular audits, and maintaining proper documentation.8. Establish distribution channels: Determine how youwill distribute your medical devices and establish relationships with distributors or retailers. This may involve attending trade shows, building partnerships, or utilizing online platforms.9. Implement marketing and sales strategies: Develop marketing and sales strategies to promote your medical devices and reach your target market. This may include creating a website, utilizing social media, attending industry conferences, and conducting product demonstrations.10. Stay updated on regulations: It is important tostay updated on any changes or updates to regulations and requirements in the medical device industry. This will help you ensure ongoing compliance and avoid any penalties or legal issues.中文回答：注册小规模医疗器械公司涉及多个步骤和流程。
注册三类医疗器械经营许可证流程Registering for a Class I Medical Device Operation Permit involves a series of steps and requirements. The first step is to submit an application to the relevant health authority in your area. The application will need to include detailed information about your business, such as the name, address, and legal representative of your company.提交申请需要包括有关您公司的详细信息，例如公司名称、地址和法定代表人等。
Once the application is submitted, the health authority will review the documents to ensure that everything is in order. This process may take some time, so it is important to be patient and follow up with the authority as needed.审核文件的过程可能需要一些时间，因此重要的是要耐心等待，并在需要时跟进有关部门。
In addition to the application form, you will also need to provide supporting documents, such as your business license, quality management system certification, and product registration certificates. These documents are necessary to demonstrate thatyour business meets the regulatory requirements for operating as a medical device distributor.除了申请表格外，您还需要提供支持文件，例如您的营业执照、质量管理体系认证和产品注册证书等。
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approvalshould be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
成立医疗器械有限公司的流程下载温馨提示:该文档是我店铺精心编制而成，希望大家下载以后，能够帮助大家解决实际的问题。
文档下载后可定制随意修改，请根据实际需要进行相应的调整和使用，谢谢!并且，本店铺为大家提供各种各样类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，如想了解不同资料格式和写法，敬请关注!Download tips: This document is carefully compiled by theeditor. I hope that after you download them,they can help yousolve practical problems. The document can be customized andmodified after downloading,please adjust and use it according toactual needs, thank you!In addition, our shop provides you with various types ofpractical materials,such as educational essays, diaryappreciation,sentence excerpts,ancient poems,classic articles,topic composition,work summary,word parsing,copy excerpts,other materials and so on,want to know different data formats andwriting methods,please pay attention!成立医疗器械有限公司的流程如下：一、初步筹划1. 确定公司名称：根据《医疗器械行业公司名称预先核准管理办法》，选择一个符合规定的公司名称，并向当地工商行政管理局进行名称预先核准。
医疗器械注册流程英文专业术语Medical Device Registration Process: English Professional TerminologyIntroductionMedical device registration is a crucial process that ensures the safety and effectiveness of medical devices before they are introduced to the market. This process involves several steps that must be followed in accordance with regulatory requirements. In this document, we will explore the medical device registration process using professional terminology in English.1. Pre-submission StageThe pre-submission stage is the initial phase of the registration process where the manufacturer collects and prepares all necessary documentation required for submission to the regulatory authority. This includes the preparation of technical documentation, clinical data, and risk management reports.2. Submission StageOnce the manufacturer has completed the pre-submission stage, they can submit their application for registration to theregulatory authority. The submission stage involves the formal submission of all required documentation, including the application form, technical files, quality management system documentation, and clinical data.3. Review StageAfter the submission of the application, the regulatory authority will conduct a review of the documentation to ensure that all requirements have been met. This review may involve a thorough examination of the technical documentation, quality management system, and clinical data to assess the safety and effectiveness of the medical device.4. Evaluation StageIn the evaluation stage, the regulatory authority will evaluate the technical documentation, quality management system, and clinical data to determine whether the medical device meets the necessary requirements for registration. This evaluation may involve testing the device in a laboratory setting or conducting a clinical trial to assess its performance and safety.5. Approval StageIf the regulatory authority determines that the medical device meets all necessary requirements, they will issue acertificate of registration, allowing the manufacturer to market the device in the country. The approval stage marks the successful completion of the registration process and allows the manufacturer to sell their medical device to healthcare providers and patients.ConclusionThe medical device registration process is a complex and time-consuming procedure that requires careful preparation and adherence to regulatory requirements. By following professional terminology in English, manufacturers can ensure that they understand and comply with the requirements for registration, thereby ensuring the safety and effectiveness of their medical devices.。
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
成立医疗器械公司流程成立医疗器械公司流程医疗器械公司注册流程：申请条件：仓库面积大于15㎡，办公室面积大于30㎡并按照药监局的要求布局(由代理方指导)第一步工商查名所需材料：1.名称预先核准申请书2.投资人身份证明3.注册资金、出资比例办理时间：材料齐全，名称不重复的情况下，3个工作日第二步医疗器械经营企业许可证申请(一)《受理通知书》所需材料：(1)《医疗器械经营企业许可证申请材料登记表》;(2)《上海市医疗器械经营企业许可证申请表》;(3)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件;(4)拟办企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;(5)拟办企业质量管理人员的身份证、学历或者职称证明复印件;(6)拟办企业组织机构与职能或专职质量管理人员的职能;(7)拟办企业注册地址、仓库地址的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议(附租赁房屋产权证明)复印件;(8)拟办企业产品质量管理制度文件(11个文件)及储存设施、设备目录;(9)拟办企业经营范围，按照医疗器械分类目录中规定的管理类别、类代号名称确定;(10)拟销售产品的委托销售方营业执照和产品注册证(复印件)、授权书;(10)电子申报材料;(浦东药检需要);(11)其它需提供的证明文件。
附：申请材料具体要求：(1)表格内容不能缺项，字迹清楚(2)同时上报申请表电子文本(放在软盘中)和A4规格的书面资料(传真纸不能作为资料上报)各一份(3)申办人提交的申办材料应齐全、规范、有效(二)《医疗器械经营企业许可证》(1)核准受理后，25个工作日内药检部门实地检查。
(2)自作出准予许可决定之日起10个工作日内颁发《医疗器械经营企业许可证》。
办理时间：材料齐全受理后，25个工作日第三步工商注册所需材料：1、全体股东指定代表或者共同委托代理人的证明(委托书)以及被委托人的工作证或身份证复印件;2、企业名称预先核准通知书;3、股东的法人资格证明或者自然人身份证明;4、公司董事长或执行董事签署的企业法人设立登记申请书;5、股东会决议(股东盖章、自然人股东签名);6、董事会决议(全体董事签名);7、公司章程(全体股东盖章)，集团有限公司还需提交集团章程(集团成员企业盖章);8、载明公司董事、监事、经理的姓名、住所的文件以及有关委派、选举或者聘用的证明，其中包括：(1)任命书(国有独资);(2)委派书(委派单位盖章);(3)公司董事长或执行董事、董事、监事、经理任职证明;(4)公司董事、监事、经理身份证复印件;9、具有法定资格的验资机构出具的验资报告;10、公司住所证明，租赁房屋需提交租赁协议书(附产权证复印件);11、公司经营范围中，属于法律、行政法规规定必须报经审批项目的，提交有关部门的批准文件;12、法律、行政法规规定设立有限责任公司必须报经审批的，提交有关部门的批准文件;13、本局所发的全套登记表格及其他材料。
