Testing standard of medical equipment

Hello, the relationship between GMP of medical devices and ISO9000 and ISO 13485 is as follows: \ x0d \ x0d \ GMP of medical devices \ x0d \ ISO 13485- for China and system assessment \ x0d \ is not stipulated by China, so it is not required to be sold in China; \x0d\ISO9000— Not applicable to medical device enterprises. \x0d\\x0d\ Let me give you a brief introduction of these three, hoping to help you. \ x0d \ x0d \ GMP for medical devices: \ x0d \ x0d \ GMP is the abbreviation of Goodman Manufacturing Practice in English, which means "good manufacturing practice" in Chinese. The World Health Organization defines GMP as a regulation that guides the production and quality management of food, drugs and medical products. \ x0d \ x0d \ GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries, which requires enterprises to meet the hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production technology, packaging and transportation, quality control, etc., to form a set of operating norms to help enterprises improve the hygiene environment, and to find out the problems existing in the production process in time and make improvements. In short, GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) meets the requirements of laws and regulations. \ x0d \ x0d \ month 1995+0, the Ministry of Health of China issued Wei Yaofa (1995) No.35 Notice on Carrying out GMP Certification. Drug GMP certification is a system that the state implements GMP supervision and inspection on drug production enterprises (workshops) and drug varieties according to law and obtains recognition. Although the international drug concept includes veterinary drugs, only a few countries, such as China and Australia, separate GMP for human use from GMP for veterinary drugs. \ x0d \ x0d \ GMP certification of drugs is divided into national level and provincial level. According to the "Regulations on the Implementation of the Drug Administration Law of People's Republic of China (PRC)", the pharmaceutical supervisory and administrative departments of the people's governments at or above the provincial level shall organize the certification of pharmaceutical production enterprises in accordance with the implementation measures and steps stipulated by the good manufacturing practice and the pharmaceutical supervisory and administrative departments of the State Council. In line with the "good manufacturing practice", issued a certificate of certification. Among them, the certification of pharmaceutical production enterprises that produce injections, radioactive drugs and biological products as stipulated by the drug supervision and administration department of the State Council is the responsibility of the drug supervision and administration department of the State Council. \ x0d \ x0d \ ISO9000: \ x0d \ iso9000 quality assurance system is the foundation for the development of enterprises. Iso9000 does not refer to a standard, but a general term for a class of standards. It is all the international standards formulated by TC 176(TC 176 refers to the Technical Committee of Quality Management System), and it is the best-selling and most common product among the standards above ISO 12000. \ x0d \ x0d \ ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communique on August 20, 2008 (the year of the fifth year), and unanimously agreed to smoothly transform the most widely used quality management system standards in the world and implement ISO900 1:2008 certification. \ x0d \ x0d \ ISO900 1: 2008 standard is based on the eight-year practice of about 1 10,000 organizations certified by ISO900 1 in 70 countries in the world, and clearly expresses iso9001:20008. \ x0d \ x0d \ 2008 edition of ISO900 1 Quality Management System Requirements: GB/T 1900 1-2008 Quality Management System Requirements are planned to be released at the end of 2008. After the release of ISO900 1:2008 standard 1 year, all certificates issued by recognized certification bodies are ISO900 1:2008 certificates; The full name of internal auditor is internal quality system auditor, who is usually familiar with ISO900 1:2008 international standards and enterprise management. According to the requirements of the new ISO900 1:2008 standard, any organization implementing the new ISO900 1:2008 standard needs to conduct internal quality audit at least once a year. Therefore, any organization that implements ISO900 1:2008 usually needs to train a group of internal auditors. Internal auditors can be part-time staff in various departments, so internal auditors play an important role in the normal operation and improvement of the quality system in an organization. \ x0d \ x0d \ iso13485: \ x0d \ x0d \ iso13485: The full name of the 2003 standard is Medical Devices-Quality Management System-Regulatory Requirements. This standard is formulated by SCA/TC22 1 Technical Committee for Standardization of Medical Device Quality Management and General Requirements, and is an independent standard based on ISO900 1:2000: 2000. This standard specifies the quality management system requirements of relevant organizations, but it is not the implementation guide of ISO900 1 standard in medical device industry. \ x0d \ x0d \ This standard has been widely implemented and applied in the world since it was published in 1996. The new ISO 13485 standard was officially released on July 3rd, 2003. Different from the ISO900 1:2000: 2000 standard, ISO 13485: 2003 is a management standard suitable for the regulatory environment: from the name, it is obviously the requirement of a regulatory quality management system. Medical devices are not only common commodities in the international business environment, but also subject to the supervision and management of national and regional laws and regulations, such as FDA in the United States, MDD (European Medical Device Directive) in the European Union, and Regulations on the Supervision and Administration of Medical Devices in China. Therefore, the standards must be bound by laws and run in a regulatory environment. At the same time, the risks of medical device products must be fully considered, and risk management is required in the whole process of medical device product realization. Therefore, apart from special requirements, it can be said that ISO 13485 is actually ISO900 1 in the medical device supervision environment. \ x0d \ x0d \ The United States, Canada and Europe generally take ISO900 1, EN4600 1 or ISO 13485 as the requirements of quality assurance system, and the establishment of medical device quality assurance system is based on these standards. To enter the markets of different countries in North America, Europe or Asia, medical devices should meet the corresponding regulatory requirements.