Apply for a medical device manufacturing license
Application conditions:?
1, the enterprise's production, quality and technical personnel should have with the production of medical devices appropriate professional ability, and master the national supervision and management of medical devices and related laws, rules and regulations and related product quality, technical provisions, the person in charge of quality shall not be concurrently responsible for the production;?
2, the enterprise above junior title or technical personnel with secondary education or more than the proportion of the total number of employees should be compatible with the requirements of the production of products
3, the enterprise should have and the production of products and production scale of production equipment, production, warehousing sites and the environment. Enterprises producing medical devices on the environment and equipment and other special requirements, should be in line with national standards, industry standards and relevant state regulations;
4, the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of quality inspection capabilities;?
5, the enterprise should be preserved with the production and operation of medical devices related laws, regulations, rules and relevant technical standards;?
6, the relevant professional title of intermediate or above, or college degree or above, full-time technical staff (the third category of production enterprises, in vitro diagnostic reagents should be not less than two,);?
7, in line with the quality management system requirements (ISO13485 training) internal auditor (the third category of production enterprises, the second category of production enterprises, in vitro diagnostic reagents production enterprises at least two, that is, one management representative, one internal auditor)
8, the production of products belonging to the state has promulgated the quality of medical device production specifications (on the issuance of medical device production quality management standard. doc) (including production implementation rules) must meet the requirements of its specifications (production implementation rules).
Medical devices are instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, monitoring, treatment, alleviation or functional compensation of injury; the examination, replacement, regulation or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
The medical device industry involves a number of industries such as pharmaceuticals, machinery, electronics, plastics, etc. It is a multidisciplinary, knowledge-intensive and capital-intensive high-tech industry. And the basic characteristics of high-tech medical equipment is digital and computerized, is a multidisciplinary, cross-field crystallization of modern high technology, its product technology content is high, high profits, and therefore the various scientific and technological powers, large international companies compete with each other on the heights of the threshold of intervention is high. Even in the industry as a whole, lower gross margins, input is not high in the sub-industry will continue to have a higher technological content of the products, and from this spawned a number of enterprises with strong profitability. Therefore, the overall trend of the industry is high input, high yield.