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. The Regulations stipulate that an overseas production enterprise that exports the first type of medical devices to China shall be submitted to the State Council's food and drug supervision and administration department for filing and filing with its representative office established within the territory of China or an enterprise legal person designated within the territory of China. The competent authority of the country (region) where the person is located permits the documentary evidence of 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 in China or an enterprise legal person designated within China. And the certification document that the competent authority of the country where the applicant is registered permits the sale of the medical device.
In addition, according to the "Regulations on the Supervision and Administration of Medical Devices": imported medical devices should have Chinese manuals and Chinese labels. The instructions and labels shall comply with the requirements of these Regulations and relevant mandatory standards, and specify the origin of the medical device and the name, address and contact information of the agent. No Chinese manual, Chinese label or manual, label does not comply with the provisions of this article, may not be imported. Therefore, the importer should replace the Chinese mark in time before the product is imported, and the corresponding Chinese manual. The inspection and quarantine department reminded that medical devices, as instruments or equipment and appliances 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 logo, medical device registration certificate and other issues. The medical devices imported by the formal channels have the entry inspection and quarantine certificates issued by the inspection and quarantine department. Imported medical device users and consumers should improve product identification capabilities, verify the corresponding entry inspection and quarantine certificate, and verify that the model number in the certificate is consistent with the model of the actual product used, and verify the product with the certificate holder or overseas manufacturer if necessary. information. (Transferred from: Zhejiang News)