In the specific work of import and export, some import and export control will be involved. In the implementation of import and export control, various working departments cooperate with the customs inspection system, in which the customs inspection system plays the role of the implementer rather than the implementer of the current policies.
In terms of the theme style of today's discussion, if a trading company exports protective masks belonging to class ii medical machinery management method, will the customs inspection system require that the trading company must have the operating qualification certificate of medical machinery? Of course it's not easy.
As we all know, the competent agency for the management of medical machinery is the state food and drug administration. Therefore, people find the state food and drug supervision and quality supervision administration order no. 8 "medical device business supervision and administration measures", in which the following provisions should be concerned:
Article 2 the theme activities and supervision of the operation of medical machinery in the region of the People's Republic of China should follow this method.
Article 4 according to the risk level of medical machinery, the management of medical machinery shall be carried out by grouping.
There is no need for approval and filing to operate category I medical machinery. The management method of filing shall be implemented for operating category ii medical machinery, and the management method of approval shall be implemented for operating category iii medical machinery.
Let the fruit explain the specific meaning of these two roots:
In article 4, the enterprise that has established the operation of class ii medical machinery shall apply for the filing, and only after the filing shall the words of class ii medical machinery be added to the business scope of the sales market supervision unit. So, as an enterprise in which situation can must apply for medical machinery record? In article 2, it is established that it can be regulated by this method under the condition of operating subject activities in the "region". Therefore, people talk about the definition of "area" and "operation" respectively.
First, "operations." In industrial and commercial bureau business license on the business scope, this is to limit the enterprise in the area of the subject activity category, with which to limit? Use the rules and regulations of the state administration of taxation. Suppose a stationery store to sell the frozen dumplings, the shop's frozen dumplings take goods tax bill according to the financial management system is not accounted for, even if the accounting violation of the provisions of accounting, for consumers is not issued to the sales invoice of dumplings, because there is no dumplings in your business scope. So why will not be subject to this limitation for export goods, because you do not need to write value-added invoice to foreigners ah, why will tax bureau tube you. In other words, the "operation" in the medical machinery operation supervision method means that the situation of buyer and seller metropolis area can be regulated by this method.
Talk about regions. In China's relevant laws and regulations for the conceptual language is unified, attention to the measures for the supervision and administration of medical equipment management in the second article is established the "region", and in the law of the People's Republic of China customs inspection system in article 2 of the customs inspection system is the shipments that environmental regulation of administrative organs, the entry and exit. This shows that the scope of supervision of the food and drug administration and the customs inspection system are different.
If others did not establish the problem, can continue to see article 6 the customs examination system act, it requires the inspection right of the customs inspection system, in view of the entry and exit vehicle can perform inspection rights immediately, and delivery vehicles for contraband behavior (no entry and exit) such as to perform the inspection authority shall perform the necessary approval processes. It is not difficult to see that the customs inspection system is unlikely to abuse its power to exercise control.
In the proposal under discussion, the scope of operation of medical machinery must be limited to those enterprises that manufacture and market medical machinery locally. If the enterprise only does the illegal inspection medical machinery import and export need not have this business scope.
The second part, the situation of export scope control
If say the business scope that the system of custom check does not do superintendency completely to the export commodity also is wrong, this kind of superintendency method is indirect sex superintendency normally is not superintendency immediately. In other words, it is not easy for the customs inspection system to check the relationship between the goods and the business scope of the enterprise at the time of export declaration. If the previous customs inspection system had not done so, it would not have been necessary during the pneumonia outbreak period, which, as mentioned in the previous paragraph, is not the scope of the customs inspection system.
The indirect supervision of the customs inspection system over the business scope of enterprises is discussed again. The example of food export shows that:
According to the requirements of article 99 of the food safety law of the People's Republic of China, "exporting food producers shall ensure that their exported food conforms to the regulations of the exporting country (region) or the provisions of the contract. Export food production enterprises and export food planting and breeding plants should register with the national entry-exit visa inspection and testing units. All of you have noticed that the export food production enterprises are supposed to file with the customs inspection system according to the text. The whole process of filing must include the business license of the enterprise covering the scope of food production and business.