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Catalogue of medical device classification standards in 2021

Catalogue of medical device classification standards in 2021

  • Categories:Industry News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-06-24
  • Views:0

(Summary description)In recent years, the State Food and drug administration has organized the preparation and revision of about 100 medical device standards every year, giving priority to the establishment of major basic standards, general standards

Catalogue of medical device classification standards in 2021

(Summary description)In recent years, the State Food and drug administration has organized the preparation and revision of about 100 medical device standards every year, giving priority to the establishment of major basic standards, general standards

  • Categories:Industry News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-06-24
  • Views:0
Information
In recent years, the State Food and drug administration has organized the preparation and revision of about 100 medical device standards every year, giving priority to the establishment of major basic standards, general standards, high-risk product standards and standards in relevant fields of strategic emerging industries. Up to now, there are 1791 valid medical device standards, including 227 national standards (93 mandatory standards and 134 recommended standards) and 1564 industrial standards (303 mandatory standards and 1261 recommended standards).
In order to facilitate the query and use of the standards, the above 1791 standards are arranged according to the general technical field and professional technical field. The general technical field is divided into 7 parts: medical device quality management, unique identification of medical devices, medical device packaging, biological evaluation of medical devices, general requirements for medical electrical equipment, general technology of disinfection and sterilization and others.
The professional and technical fields are subdivided into 32 parts: surgical instruments, medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic instruments and reagents.
The basic principles of standard arrangement are: national standards before industrial standards; Standards at the same level shall be numbered in the order of standards; Standards in professional and technical fields shall be general standards first, then product standards and method standards, and series or similar standards shall be side by side. Some series of standards may not be completely consistent due to different professional fields, integration or revision.
Medical device standard is a technical specification jointly followed by the development, production, operation, use, supervision and management of medical devices. It is an important technical support to standardize the supervision of medical devices and promote industrial development. The State Food and Drug Administration attaches great importance to the work of medical device standards. In accordance with the requirements of the "four strictest" and in combination with the actual situation of industrial development and supervision, it has continuously improved the medical device standard management system and continued to carry out the preparation and revision of medical device standards. China's medical device standard system has been continuously improved, The technical support ability of medical device standards for supervision and industrial development has been continuously improved.
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China's medical device industry is developing rapidly
China's medical device industry is developing rapidly
The primary medical institutions in the second and third tier counties and towns will be the top priority of China's medical device market in the next few years. The economically backward areas, including the central and western regions, will also be the focus of future development. With the growth of consumption strength in these areas, the investment in national medical reform will increase from time to time, and the growth space of districts and counties will be quite broad.
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The primary medical institutions in the second and third tier counties and towns will be the top priority of China's medical device market in the next few years. The economically backward areas, including the central and western regions, will also be the focus of future development. With the growth of consumption strength in these areas, the investment in national medical reform will increase from time to time, and the growth space of districts and counties will be quite broad.
Do you know any medical devices?
Do you know any medical devices?
Many people think that medical devices only refer to the equipment and instruments that will be used in major surgery. In fact, this is only one of them. For example, our common bandages, gauze and even hemostatic patches can also be medical devices, such as various medical devices produced by Daguang pharmaceutical.
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Many people think that medical devices only refer to the equipment and instruments that will be used in major surgery. In fact, this is only one of them. For example, our common bandages, gauze and even hemostatic patches can also be medical devices, such as various medical devices produced by Daguang pharmaceutical.
Catalogue of medical device classification standards in 2021
Catalogue of medical device classification standards in 2021
In recent years, the State Food and drug administration has organized the preparation and revision of about 100 medical device standards every year, giving priority to the establishment of major basic standards, general standards
See more information
In recent years, the State Food and drug administration has organized the preparation and revision of about 100 medical device standards every year, giving priority to the establishment of major basic standards, general standards
Definition of medical devices
Definition of medical devices
In the medical device quality management specifications and related specifications formulated and issued by the International Standard Organization ISO, in the 1980s
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In the medical device quality management specifications and related specifications formulated and issued by the International Standard Organization ISO, in the 1980s
The consequences of overdue use of medical devices are very serious
The consequences of overdue use of medical devices are very serious
本报讯(记者王岚通讯员夏静励彤)日常生活中,有些设施设备,虽然有明确的使用期限,但因为各种原因,超期使用的也不少。但这样的情况,如果出现在医疗器械上,那就是违法行为,后果有点严重。近日,海曙区市场监管局在医疗机构专项检查中,就查处了这样一起案件。  执法人员在一中医门诊部检查时,发现在用的一批名为特定电磁波治疗器的医疗器械超出使用期限却仍在正常使用,违反了刚修订的《医疗器械监督管理条例》。这是新修
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本报讯(记者王岚通讯员夏静励彤)日常生活中,有些设施设备,虽然有明确的使用期限,但因为各种原因,超期使用的也不少。但这样的情况,如果出现在医疗器械上,那就是违法行为,后果有点严重。近日,海曙区市场监管局在医疗机构专项检查中,就查处了这样一起案件。  执法人员在一中医门诊部检查时,发现在用的一批名为特定电磁波治疗器的医疗器械超出使用期限却仍在正常使用,违反了刚修订的《医疗器械监督管理条例》。这是新修
Knowledge of common medical devices
Knowledge of common medical devices
Q: what are the types of commonly used thermometers?A: glass thermometer is the most common thermometer. It can keep the mercury column rising with body temperature in its original position after leaving the human body, which is convenient for users to observe at any time.
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Q: what are the types of commonly used thermometers?A: glass thermometer is the most common thermometer. It can keep the mercury column rising with body temperature in its original position after leaving the human body, which is convenient for users to observe at any time.
Congratulations to Chongqing pangtong medical device Co., Ltd. for winning the award of high-tech enterprise for two consecutive times
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hot wire! hot wire! A new batch of product registration certificates have come down!
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hot wire! hot wire! A new batch of product registration certificates have come down!
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Time of issue:2021-06-28 17:52:44

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