Agent Import of Class I and Class II Medical Devices
Enterprises declaring the export of medical devices must ensure that the exported medical devices meet the requirements of the importing country (region). Generally, the exporting country does not inspect the goods.
What are the Procedures for Importing Medical Device Equipment and Precautions for Customs Declaration?
The medical device industry is highly regulated with corresponding laws. China implements risk classification and catalog management for medical devices, which are legally controlled commodities. Therefore, enterprises must understand relevant regulations of medical device import/export authorities and master related procedures.
The scope of medical devices is extensive, ranging from surgical knives and infusion sets to magnetic resonance imaging (MRI) equipment, CT scanners, cardiac pacemakers, and vascular stents—all classified as medical devices.
Three Essential Certificates and Processes for Exporting Medical Masks
Detailed analysis of the import process for endovenous radiofrequency closure generators, covering required documents, tariffs, and operational steps to facilitate smooth customs clearance.
The import of tractor head equipment needs to strictly comply with regulations, and the steps are complex, including signing agreements, providing product information, customs approval, transportation and customs clearance, tax payment and inspection, etc. This article analyzes the process and required materials in detail to help importers operate smoothly.
Analyze the compliance requirements for the return and repair of imported medical devices, discuss the difficulties in customs clearance and the restrictions on bonded area repairs, and provide alternative solutions.
Detailed explanation of the regulatory requirements for exporting medical products to Spain, including customs clearance documents, special permits, CE certification, and AEMPS registration, as well as practical suggestions and risk control strategies.
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PSB Record: Shanghai No.31011502009912
