Medical device industry organizations should strengthen industry self-discipline to promote what system construction

Medical device industry organizations should strengthen industry self-regulation, promote integrity system construction, supervise enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software. Medical devices include medical equipment and medical consumables. The utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or although these means are involved but only in an auxiliary role. The purpose is the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, substitution, 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 China Association of Medical Devices Industry (CAMDI), founded in 1991, is an independent legal person registered with the Ministry of Civil Affairs of the People's Republic of China. It is an industrial, non-profit social organization formed by units or individuals engaged in the production, operation, scientific research and development, product testing, and education and training of medical devices nationwide on a voluntary basis. The competent authority is the State-owned Assets Supervision and Administration Commission of the State Council, which is administered by the China Federation of Industrial Economics, and at the same time accepts the business guidance of the Ministry of Civil Affairs, the State Food and Drug Administration and other relevant departments. On the basis of compliance with national policies and regulations, on behalf of the member units of the **** the same interests, to safeguard the legitimate rights and interests of the member units, and constantly improve the safety and effectiveness of medical devices, to promote the healthy development of China's medical device industry.

Legal basis:

"Regulations for the Supervision and Administration of Medical Devices"

Article XI of the medical device industry organization shall strengthen industry self-discipline, promote the construction of the integrity system, supervise enterprises to carry out production and management activities in accordance with the law, and guide the enterprises to be honest and trustworthy.

Article VI of the state of medical devices in accordance with the degree of risk to implement the management of classification. The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a moderate risk, the need for strict control management to ensure its safety, effective medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors. The drug supervision and management department of the State Council is responsible for formulating the classification rules and classification catalog of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalog. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory shall be published to the community.

Article VII of the medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices.

Article VIII of the state to develop medical device industry planning and policy, medical device innovation into the development of key, innovative medical devices to be prioritized for review and approval, to support the clinical promotion and use of innovative medical devices, and to promote high-quality development of the medical device industry. The drug supervision and management department of the state council shall cooperate with the relevant departments of the state council to implement the national medical device industry planning and guiding policies. Article 9 The state shall improve the medical device innovation system, support the basic and applied research of medical devices, promote the promotion and application of new technologies of medical devices, and support scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. It supports enterprises to set up or jointly establish research and development organizations, encourages enterprises to cooperate with universities, research institutes and medical institutions to carry out research and innovation of medical devices, strengthens the protection of intellectual property rights of medical devices, and improves the independent innovation capability of medical devices.

Article X of the state to strengthen the supervision and management of medical devices information construction, improve the level of online government services, administrative licensing for medical devices, filing and other facilities.