The demand for high-end imported medical devices is growing as the medical network improves at home on May 23. Medical apparatus and instruments as a direct or indirect instruments, equipment and instruments used in the human body, is closely related to ordinary people's life and health security, therefore, such products importers in import declaration should be carried out in strict accordance with the relevant requirements, especially the Chinese label, medical device registration certificate, and other issues. 

 

In ningbo area, for example, 1 to April, 2017, ningbo port, a total of 170 batch of import medical instrument examination, the amount of $27.438 million, compared with the same period last year growth of 39.3% and 39.3% respectively. The product mainly USES diagnostic type medical equipment mainly, check out unqualified imported medical equipment 4 batches. One of them was ordered to be destroyed for failing to provide the registration certificate for imported medical instruments. 

 

It is understood that since last year, Shanghai, guangdong, shenzhen, shaanxi and other regions of inspection and quarantine departments repeatedly found that do not conform to the rules to import all kinds of medical equipment in China. In view of this, the inspection and quarantine department warns that importers and users of all kinds of medical devices should pay attention to the following three requirements: 

 

First, the record and registration are required 

 

Medical devices, as a kind of products that are closely related to human health and life safety, produce, operate and use strict management system. The regulations on the supervision and administration of medical devices (state council order no. 650) to be engaged in the development of medical equipment in China, production, management and use activities and supervision and management to make the rules. 

 

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. 

 

Chinese logo and instruction manual 

 

In the case of import inspection and regulation, the main products of imported medical instruments are found to be more important than those in Chinese. According to the regulations on the supervision and administration of medical devices, the imported medical instruments shall have Chinese instruction and Chinese labels. Manual, label shall comply with these regulations and compulsory standards requirements, and the origin of medical apparatus and instruments as stated in the specification and the agent's name, address, contact information. No import shall be imported without the Chinese instruction, the Chinese label or the instruction and the label. Therefore, the importer should replace the Chinese logo before the import and match the corresponding Chinese instruction. 

 

Verification of the entry inspection and quarantine certificate 

 

Medical instruments imported from the normal channel have inspection and quarantine certificates issued by the inspection and quarantine department. Imported medical equipment users and consumers should improve product recognition, to verify the corresponding incoming goods inspection and quarantine certificate, and verification certificate model and the actual use of product model are consistent, with necessary certificate holder or overseas manufacturers to verify the product information.