Medical device product certification, that is to say, the product factory through the manufacturer's factory inspection certificate. Due to the limited space in the box, or the need for technical confidentiality, usually will not give you a random medical device self-test report, then how to prove that the product meets the requirements of the safety of the factory? Just rely on such a certificate of conformity.
This certificate of conformity belongs to the homemade, there is no certain format specification. The content of the main three: whether qualified, which inspector, inspection date.
So if the machine has a problem, the test did not check out, you can directly find out the day of the test by which inspector for the test, who is the problem. Reasonable traceability .
Extended information:
Chapter 1
General?
Article 1, in order to strengthen the supervision and management of product quality, improve product quality, product quality responsibility, protect the legitimate rights and interests of consumers, and maintain the social and economic order, the formulation of this law.
Second, in the Chinese people's *** and the State engaged in the production of products, sales activities, must comply with this Law. The products referred to in this law refers to the products that are processed, made and used for sale.
Construction projects are not subject to the provisions of this Law; however, construction materials, building components and equipment used in construction projects that fall within the scope of the products specified in the preceding paragraph are subject to the provisions of this Law.
Article 3, producers, sellers should establish and improve the internal product quality management system, the strict implementation of job quality standards, quality responsibility and the corresponding assessment methods.
Article 4, producers, sellers in accordance with the provisions of this Law to assume responsibility for product quality.
Article 5, it is prohibited to forge or fraudulent use of certification marks and other quality marks; it is prohibited to forge the origin of the product, forged or fraudulently use another person's factory name and address; prohibited in the production and sale of products adulterated, adulterated, fake for the real, and substituting the best for the best.
Article VI, the state encourages the implementation of scientific quality management methods, the use of advanced science and technology, and encourages enterprise product quality to meet and exceed industry standards, national standards and international standards. Advanced product quality management and product quality to reach the international advanced level, remarkable achievements of units and individuals, be rewarded.
Article VII, the people's governments at all levels shall improve the quality of products into the national economy and social development planning, strengthen the product quality of the work of the overall planning and organization and leadership, guidance and supervision of producers and sellers to strengthen product quality management, improve product quality, and organization of the relevant departments in accordance with the law to take measures to stop the production and sale of products in violation of the provisions of this Law, and to ensure the implementation of the Law.
Article 8, the State Council market supervision and management department in charge of national product quality supervision. The relevant departments of the State Council in their respective areas of responsibility for product quality supervision.
Local market supervision and management departments at or above the county level in charge of product quality supervision within the administrative region. The relevant departments of the local people's government above the county level in their respective areas of responsibility for product quality supervision. The law on product quality supervision department otherwise provided, in accordance with the provisions of the relevant laws.
Article IX, the people's governments at all levels and other state organs shall not abuse their powers, dereliction of duty or favoritism, harboring, indulgence in the region, the system of product production, sales of violations of the provisions of this Law, or obstruct, interfere with the law on product production, sales of violations of the provisions of this Law to investigate and deal with.
Local people's governments at all levels and other state organs have harbored or indulged in the production and sale of products in violation of the provisions of this Law, shall be investigated in accordance with the law of the legal responsibility of its principal officers.
Article 10, any unit or individual has the right to violation of the provisions of this Law, to the market supervision and management departments or other relevant departments to report. Market supervision and management departments and other relevant departments shall maintain the confidentiality of the informant, and in accordance with the provisions of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government to reward.
Article 11, no unit or individual shall not be excluded from the region or non-system enterprises produce quality products into the region, the system.
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