Medical devices, as instruments or equipment used directly or indirectly in the human body, are closely related to the health and safety of ordinary people. Therefore, importers of such products must declare in strict accordance with relevant requirements when importing.
With the continuous improvement of domestic medical standards, the demand for high-end imported medical devices is increasing. Medical devices, as instruments or equipment used directly or indirectly in the human body, are closely related to the health and safety of ordinary people. Therefore, importers of such products must declare in strict accordance with relevant requirements when importing, especially Chinese signs and medical devices. Registration card and other issues.
Taking Ningbo area as an example, from January to April 2017, Ningbo Port completed a total of 170 batches of imported medical device inspections, amounting to USD 27.438 million, an increase of 39.3% and 77.8% compared with the same period of last year. The products are mainly based on diagnostic medical equipment , and a total of 4 batches of unqualified imported medical devices were detected. One of the batches was ordered to be destroyed because it could not provide the Imported Medical Device Registration Certificate. It is reported that since last year, inspection and quarantine departments in Shanghai, Guangdong, Shenzhen, Shaanxi and other regions have repeatedly found various types of medical devices that do not comply with China's relevant regulations. In view of this, the inspection and quarantine department reminds all types of medical device importers and users to pay attention to the following three requirements:
First, need to file and register
As a kind of product closely related to human health and life safety, medical equipment has strict management system for its production, operation and use. Among them, the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council) has made relevant provisions on the development, production, operation and use of medical devices and their supervision and management in China.
With the continuous deepening of import and export trade, more and more enterprises are beginning to engage in the operation of imported medical devices, but some enterprises do not know much about the filing and registration of products. The regulations specifically explain the filing and registration of imported medical devices. The overseas production enterprise that exports the first type of medical equipment to China shall be the representative of the representative office established in China or the enterprise legal person designated in China, and submit the filing materials and the record holder to the food and drug supervision and administration department of the State Council. The competent authority of the country (region) permits the certification document for the sale of the medical device. An overseas production enterprise that exports Class II and Class III medical devices to China shall submit its application for registration to the Food and Drug Administration of the State Council as an agent of its representative office established within the territory of China or an enterprise legal person designated within the territory of China. And the certification document that the competent authority of the country where the applicant is registered permits the sale of the medical device.
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