Hello, what is a medical device product certificate? Do you have any samples?

Medical device product certificate means that the product has passed the factory inspection of the manufacturer. Due to the limited packaging space or the need of technical confidentiality, we will not give you the self-inspection report of medical devices at random. How do you prove that the product meets the requirements of safe delivery? With such a certificate.

This certificate is self-made and has no certain format specification. There are three main contents: whether it is qualified, which inspector and the inspection date.

In this way, if there is something wrong with this machine and the inspection fails to detect it, we can directly find out which inspector conducted the inspection on the inspection day and who had the problem. Reasonable traceability.

Extended data:

chapter one

General rules?

Rule number one. This Law is formulated in order to strengthen supervision and management of product quality, improve product quality level, clarify product quality responsibilities, protect consumers' legitimate rights and interests, and maintain social and economic order.

Article 2. Anyone who engages in the production and sale of products within the territory of People's Republic of China (PRC) must abide by this Law. The term "products" as mentioned in this Law refers to products that have been processed and manufactured for sale.

The provisions of this law are not applicable to construction projects; However, if the building materials, building components and equipment used in construction projects fall within the product scope specified in the preceding paragraph, the provisions of this Law shall apply.

Article 3. Producers and sellers shall establish and improve the internal product quality management system, and strictly implement post quality standards, quality responsibilities and corresponding assessment methods.

Article 4. Producers and sellers shall be responsible for product quality in accordance with the provisions of this law.

Fifth, it is forbidden to forge or fraudulently use quality marks such as certification marks; It is forbidden to forge the origin of products, forge or falsely use the name and address of others; It is forbidden to adulterate and adulterate the products produced and sold, and to pass the fake off as the real one and pass the inferior one as the good one.

Article 6. The state encourages the implementation of scientific quality management methods and the adoption of advanced science and technology, and encourages enterprises to meet or exceed industry standards, national standards and international standards in product quality. Units and individuals with advanced product quality management and outstanding achievements in product quality reaching the international advanced level shall be rewarded.

Article 7. People's governments at all levels should incorporate the improvement of product quality into the national economic and social development plan, strengthen the overall planning and organizational leadership of product quality work, guide and urge producers and sellers to strengthen product quality management, improve product quality, organize relevant departments to take measures according to law, stop violations of this Law in product production and sales, and ensure the implementation of this Law.

Eighth the State Council market supervision and management departments in charge of national product quality supervision. Relevant departments of the State Council are responsible for product quality supervision within their respective responsibilities.

Local market supervision and management departments at or above the county level shall be in charge of product quality supervision within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for product quality supervision within the scope of their respective duties. Where the law provides otherwise for the product quality supervision department, the relevant laws shall prevail.

Article 9. Staff members of people's governments at all levels and other state organs shall not abuse their powers, neglect their duties, engage in malpractices for selfish ends, cover up or condone acts that violate the provisions of this law in the production and sale of products in their own regions and systems, and shall not obstruct or interfere in investigating and handling acts that violate the provisions of this law in the production and sale of products according to law.

Local people's governments at all levels and other state organs that cover up or indulge in violations of this law in the production and sale of products shall be investigated for legal responsibility according to law.

Article 10 Any unit or individual has the right to report any violation of this Law to the market supervision and administration department or other relevant departments. The market supervision and management departments and relevant departments shall keep confidential the informants and reward them in accordance with the provisions of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.

Eleventh any unit or individual shall not exclude qualified products produced by enterprises not in the region or the system from entering the region or the system.

References:

Baidu Encyclopedia-People's Republic of China (PRC) Product Quality Law