Chinese Medical Devices Industry Association Convention
I. General Provisions
1, the basis for the development of the Convention. In order to revitalize and develop China's medical device industry to maintain the market economic order, to protect the medical device industry *** with the rights and interests and corporate reputation, in accordance with the laws and regulations relating to the management of medical devices, has formulated the "rules and regulations of the Convention.
2, "the purpose of the Convention" in the relevant government departments under the leadership and support to establish the medical device industry and enterprise self-discipline mechanism, standardize the industry and enterprise production and management behavior, improve the overall quality of the industry, establish a good image of the industry as the fundamental purpose.
3, the scope of compliance with the Convention. Where engaged in the medical device industry research, development, production and operation of enterprises should comply with the "Convention".
4, China Medical Devices Industry Association Council is responsible for the development, modification, implementation supervision, inspection and management of the Convention.
Two, industry ethics
1, to improve the level of civilized production and management, quality service, adhere to the implementation and consciously regulate the industry's production, operation, service, management behavior.
2, advocate strict management, strengthen the infrastructure, establish and improve the industry and enterprise rules and regulations to improve the level of enterprise production and management.
3, advocate learning science, knowledge, technology, and constantly improve the quality of all staff, wholeheartedly for the people.
4, advocating industry solidarity, mutual assistance, coordination, self-discipline, *** with the market responsibility, the overall advantage of the industry, the industry's hot spots, difficulties and major issues, take the seminars, consultations and other ways to solve.
5, advocate compliance with the law, honesty and integrity, credibility, self-respect and self-discipline, strictly legal business, enhance legal awareness, and further improve the industry, corporate image and spiritual civilization.
Third, the convention
1, in the production and management activities, should comply with the principles of openness, fairness, honesty and proper competition, strict implementation of relevant state laws and regulations, consciously maintain the normal order of production and operation of the industry;
2, strict medical device products, research, development, production and operation of the relevant technology, technology, quality standards and norms, adhere to the quality first, prohibit the production, sale and distribution of medical equipment products. Quality first, prohibit the production and sale of medical equipment products, unregistered medical equipment products and medical equipment products that fail to meet the standards of the state expressly prohibited the use of medical equipment products;
3, the strict implementation of the provisions of the product price, obeisance to the industry's self-discipline price, shall not be arbitrarily raised prices or prices, and prohibited to the detriment of the interests of other operators and consumers;
4, strictly abide by the relevant regulations of the industry and commerce, taxation and finance, to avoid giving out of account the normal order of production and operation. Strictly abide by the relevant laws and regulations of industry and commerce, taxation, finance, etc., and put an end to bribe-giving and bribe-taking behaviors, such as giving and receiving rebates off the books.
5, consciously abide by the relevant national intellectual property protection system and laws, do not infringe on the technical and commercial secrets of others.
Four, industry management
In addition to providing the government and enterprises with decision-making basis and countermeasures, organizing technical exchanges, economic cooperation, training and information services and a series of management functions, according to the State Economic and Trade Commission in the "industry associations in the pilot program of the Association's industry management functions, the Association focus on the implementation of the following five self-regulatory industry management Functions:
1, according to the characteristics of the medical device industry, the development of "rules and regulations", the establishment of industry self-regulatory mechanism to promote parallel competition, improve the overall quality of enterprises, and safeguard the overall interests of the industry;
2, with the relevant government departments to develop and revise industry standards (except for enterprise standards), and organize and promote the implementation of standards, and actively assist, cooperate and participate in the relevant departments to carry out line inspection and evaluation work, and actively assist the relevant departments to carry out line inspection and evaluation work. Departments to carry out line inspection and evaluation work, products and enterprises that do not meet the quality standards and other standards to supervise and rectify, and even recommend the relevant government departments to take administrative measures. Organization and implementation of ISO9000 technical training;
3, price management within the industry, the organization of bargaining with the industry, the price of the agreement within the industry to guide, supervise, and coordinate;
4, for the medical device industry, the actual layout, collection, collation and analysis of industry statistics, for the government to develop industrial policy to provide the basis for business decision-making services;
5, to assist and participate in the relevant departments to carry out inspection and evaluation of the industry, and other standards of products and enterprises to supervise and rectify, and even recommended to the relevant government departments to take administrative measures. /p>
5, accept the relevant departments entrusted to the medical device major investment, transformation, development based on the advanced, economic and reliability of the demonstration, as an important basis for approval, and participate in the responsibility to monitor and recommend the industry's high-tech products, brand-name products and technological achievements.
6. Regulate and strengthen market management, cooperate with the government to formulate relevant policies and regulations, and promote the healthy development of national industry.
7. To standardize the supervision and management of foreign enterprises in the national market, and to stop falsification, malicious competition and dumping.
V. Management of the Statute
1. Promote the implementation of the Statute, carry out evaluation activities, and give commendations and rewards to the units and legal persons with outstanding achievements in the implementation of the Statute and make public commendations and publicity in various forms;
2. Reception and acceptance of letters and visits, and handle the work;
3. Organize investigations into the violations of the Statute and make opinions on the treatment;
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4, the violation of the statute, mainly in the form of criticism and education, apologies, compensation for losses, in order to achieve the purpose of correcting the error. To continue to violate the breach of the unit to take internal notification, industry exposure, moral condemnation, expulsion from the membership, as well as recommending government departments to give warning, serious warning, revocation of production (business) license, until the legal prosecution, in order to maintain the seriousness of the statute;
5. Where the handling of the dissatisfaction, you can put forward a reconsideration of the views of the Association, the Association organized by the staff to investigate the matter, and then submitted to the Council of the Association for consideration.