Agent Import of Class I and Class II Medical Devices
When exporting medical devices to the Russian market, understanding the relevant certification and market access requirements is crucial. Russian legislation and regulatory agencies for medical devices aim to ensure product safety and compliance. Below are the certification requirements to consider when exporting medical devices to Russia:
With the continuous development of medical technology, medical devices have become an indispensable part of modern healthcare. Many medical devices need to be imported from abroad, making it particularly important to understand the procedures and formalities for importing medical devices. In this article, we will introduce the definition, classification, and required import procedures for medical devices.
Importing dental medical equipment through agencies requires meeting specific conditions to ensure compliance with national regulations/quality standards and user safety/health protection.
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.
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PSB Record: Shanghai No.31011502009912
