GMP is a set of mandatory standards for pharmaceutical, food and other industries, requiring companies to meet health quality requirements from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations, to form a set of operational practices to help companies improve the health of the business 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.
So the medical device manufacturing enterprises need to carry out GMP certification.