GMP-for medical devices-for China, it is for systematic evaluation.
Mian O13485-is not a system regulation in China and is not required to be sold in China;
I will give you a brief introduction of these three, hoping to help you.
Medical device GMP:
GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, which means "product quality management standard" in Chinese. The World Health Organization defines GMP as a regulation that guides the production and quality management of food, drugs and medical products.
GMP is a set of mandatory standards applicable to pharmaceutical and food industries, which requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, and quality control. , and form a set of operating norms to help enterprises improve the sanitary environment, timely find the problems existing in the production process and improve them. 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.
The Ministry of Health of China issued the Notice of Wei Yaofa (1995) No.35 on Developing GMP Certification on July1995. 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.
Drug GMP certification is divided into national and provincial levels. 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.
ISO9000:
? Quality assurance system is the foundation of enterprise development. Mian O9000 is not 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.
ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communique on August 20, 2008 (the year of the fifth year), agreeing to smoothly transform the most widely used quality management system standards in the world and implement ISO900 1:2008 certification.
Mian O900 1:2008 standard is based on eight years' practice in 170 countries and about 1 10,000 organizations around the world, which clearly expresses the requirements of ISO900 1:2008 and strengthens the connection with ISO 140066.
ISO900 1 Quality Management System Requirements The 2008 edition is scheduled to issue GB/T 1900 1-2008 Quality Management System Requirements 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.
ISO 13485:
The full name of ISO 13485: 2003 standard is the legal requirement of medical device quality management system. 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.
Since the publication of 1996, this standard has been widely implemented and applied in the world. 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.
The United States, Canada and Europe generally take ISO 900 1, EN 4600 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.