Medical equipmentImportation is the gateway, the file involved is more complex than the human cardiac chart, and the classification management is more detailed than the diagnosis of diseases. Below, let us analyze for you the importation of medical devices A to Z, helping you avoid small plugs when importing, making sure each step is step by step!

Documents Required for Import of Medical Devices

For the import of medical devices, you need to prepare a series of documentation to ensure smooth customs. These documents include but are not limited to contracts, invoices, receipts, but may also require automatic import licenses, mandatory certification certificates, business licenses for importers, etc. Certain devices or diagnostic reagents may also require other special licenses or approvals. Make sure you have all the necessary documents before you start importing to avoid any unnecessary delays.

Classification of Medical Devices

According to the level of risk of medical devices, medical devices are classified into three categories:
The first category:These types of medical devices are relatively low in risk, such as common diagnostic devices and basic surgical devices.
? The second category:Such devices are at moderate risk and require stricter management, such as medical protective masks and medical high-frequency instrument equipment.
? Third category:These are the highest-risk medical devices, such as implanted heartbeaters and laser surgical devices.

Management of medical device products

For different categories of medical devices, different management measures have been implemented.
Category 1 Medical Equipment:Implementation of product record management.Overseas production enterprises need to submit documentation data and relevant certification documents.
Class II and Class III medical devices:Foreign production enterprises need to submit relevant information to the Food and Drug Administration Department under the State Council.

Management of Medical Device Operating Units

Medical device operating units need to file or apply for business permission according to the category of medical device they operate. Class 1 medical devices do not need to file or business permission; Class 2 medical devices need to file; and Class 3 medical devices need to apply for business permission.

Imports and operations of medical devices are strictly regulated and supervised in our country. Whether you are a manufacturer, importer or distributor, you need to ensure that you follow all regulations and guidelines to ensure that you provide consumers with safe and efficient medical devices.

We can provide medical device agent import and clearance goods shipping services to customers, mainly responsible for the first class and second class medical device agent import services.