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As medical devices continue to improve, we still need to pay attention to three problems

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As medical devices continue to improve, we still need to pay attention to three problems

Date of issue:2019-07-27 author:Qingdao DMD Medical Technology Co. LTD click:

Ligate vessel clamp With the continuous improvement of domestic medical level, the demand for high-end imported medical equipment is increasing day by day. Medical devices, as instruments, equipment and instruments directly or indirectly used in human body, are closely related to the life, health and safety of ordinary people. Therefore, importers of such products should declare in strict accordance with relevant requirements when importing, especially Chinese labels, medical device registration certificate and other issues.

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Taking Ningbo as an example, from January to April of 2017, Ningbo port completed 170 batches of imported medical device inspection, with a total amount of US $27.438,000, an increase of 39.3% and 77.8% compared with the same period last year. The products are mainly diagnostic medical equipment, and a total of 4 batches of unqualified imported medical equipment were detected. One batch of them was ordered to be destroyed because they could not provide the Registration Certificate of Imported Medical Devices. It is reported that since last year, inspection and quarantine authorities in Shanghai, Guangdong, Shenzhen, Shaanxi and other regions have repeatedly found all kinds of medical devices that do not comply with China's relevant regulations. In view of this, the inspection and quarantine authorities remind importers and users of all kinds of medical devices to pay attention to the following three requirements:


一、Medical devices, as a kind of products closely related to human health and life safety, have a strict management system for their production, operation and use. Among them, regulations on the Supervision and Administration of Medical Devices (Decree No. 650 of the State Council) makes relevant provisions on the research, production, management and use of medical devices in China, as well as their supervision and administration. With the deepening of the import and export trade, more and more enterprises begin to engage in import of medical equipment management, but some companies have not understanding of archival filing and registration, the regulation especially on imported medical instruments to illustrate the archival filing and registration, exports to China of overseas production enterprise of class I medical devices by its representative offices established in the territory of China or designated enterprise as a legal person as agent within the territory of China, submitted to the food and drug supervision and administration department under the State Council for the record data and record people's country (region) permitted by the competent department of the medical equipment market. To export category ii and class iii medical devices in our country's overseas production enterprise, should by its representative offices established in the territory of China or designated enterprise as a legal person as agent within the territory of China, to the food and drug supervision and administration department under the State Council shall submit an application for registration information and registration of the applicant's country (region) permitted by the competent department of the medical equipment market.


二、From the previous import inspection and supervision cases, it can be found that the major products of imported medical devices do not conform to the provisions of the labels and instructions in Chinese. According to the regulations on the Supervision and Administration of Medical Devices, imported medical devices shall have instructions and labels in Chinese. The specifications and labels shall comply with the provisions of these Regulations and the requirements of relevant mandatory standards, and the origin of the medical devices and the name, address and contact information of the agents shall be specified in the specifications. No import shall be allowed if there is no Chinese specification or Chinese label or the specification or label is not in conformity with the provisions of this Article. Therefore, the importer should timely change the Chinese label and attach the corresponding Chinese instruction manual before the product is imported.


三、Check the entry inspection and quarantine certificate The entry inspection and quarantine certificate issued by the inspection and quarantine department for all medical devices imported through regular channels. Users and consumers of imported medical devices should improve their product identification ability, verify the corresponding inspection and quarantine certificate of the entry goods, and verify whether the model in the certificate is consistent with the model of the actual product used, and verify the product information with the certificate holder or foreign manufacturer when necessary.

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