Medical device GMP - for China, it is for the system assessment
ISO13485- -is not a system regulation for China, and is not required for sales in China;
ISO9000-is not for medical device companies.
Below I will give you a brief synopsis of all three, which I hope will help you.
Medical device GMP:
GMP is the abbreviation of GOOD MANUFACTURING PRACTICE, 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.
GMP is a set of mandatory standards for pharmaceutical, food and other industries, requiring companies to meet the health and quality requirements from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations, the formation of a set of operational practices to help companies improve the health of the corporate environment, timely detection of problems in the production process, to improve. Briefly, GMP requires pharmaceutical, food and other production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the final product quality (including food safety and health) in line with regulatory requirements.
China's Ministry of Health in July 11, 1995 issued Wei drug hair (1995) No. 35 "on the development of drug GMP certification notice". Drug GMP certification is the state according to law on drug production enterprises (workshop) and drug varieties to implement GMP supervision and inspection and obtain recognition of a system. Although the international concept of pharmaceuticals includes veterinary drugs, only a few countries, such as China and Australia, are separating the GMP of human drugs from the GMP of veterinary drugs.
Drug GMP certification is carried out at the national and provincial levels, and according to the "Chinese People's **** and the State Drug Administration Law Implementation Regulations", the drug supervision and management department of the people's government at the provincial level or above shall, in accordance with the "Good Manufacturing Practices for Drugs" and the State Council drug supervision and management department of the implementation of the prescribed implementation methods and implementation steps, organize the certification of drug manufacturers; in line with the "Good Manufacturing Practice", the certification shall be issued to those who meet the certification criteria and the certification requirements. Good Manufacturing Practice", issued a certificate of authentication. Among them, the production of injections, radioactive drugs and biological products under the State Council drug supervision and management department of the certification of drug manufacturers, the State Council drug supervision and management department is responsible for.
ISO9000:
ISO9000 quality assurance system is the fundamental development and growth of enterprises, ISO9000 does not refer to a standard, but a category of standards collectively. Is developed by the TC176 (TC176 refers to the quality management system technical committee) of all international standards, is ISO12000 more than one standard in the best-selling, most common products.
ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communiqué on August 20, 2008 (e.g., 2008), agreeing on the smooth conversion of the world's most widely used quality management system standards and the implementation of ISO9001:2008 certification.
The ISO9001:2008 standard is based on eight years of practice by approximately one million ISO9001-certified organizations in 170 countries around the world, and expresses the requirements of ISO9001:2008 more clearly and unambiguously and enhances compatibility with ISO14001:2004.
The 2008 version of the ISO9001 "Quality Management System Requirements" international standard is scheduled to be released at the end of 2008 GB/T 19001-2008 "Quality Management System Requirements". 1 year after the release of the ISO9001:2008 standard, all certificates issued by accredited certification bodies are ISO9001:2008 certificates; Internal Auditor An internal quality system auditor is a person who is well versed in the ISO9001:2008 international standard and familiar with the management of the organization. According to the requirements of the new ISO9001:2008 standard, all organizations implementing the new ISO9001:2008 standard need to conduct an internal quality audit at least once a year, so all organizations implementing ISO9001:2008 usually need to train a group of internal auditors. Internal auditors can be part-time staff from various departments, so internal auditors play an important role in the normal operation and improvement of the quality system in an organization.