What are the Procedures for Importing Medical Device Equipment and Precautions for Customs Declaration?

ImportMedical EquipmentWhat documents/processes are required

(1) Import medical device registration certificate and business license issued by the National Medical Products Administration;

(2) For medical devices containing drug components, a China Compulsory Certification Certificate (Special Item Approval Form) should be provided;

(3) Some equipment requires an Automatic Import License (O Certificate);

(4) Equipment photos, nameplates, technical parameters, end-use, Chinese instruction manual, etc.;

(5) Import contract, packing list, invoice;

(6) Other required supplementary materials.

Customs inspection considerations for importing medical equipment:

(1). Select entry port—determined based on cargo volume and familiarity;

(2) Whether the customs declaration documents are complete—in addition to general import goods, all documents required for importing medical equipment must be prepared one by one.

The receiving unit for imported medical equipment should have the following qualifications:

(1) Medical device business license;

(2) Business license (with the scope of business including the sale of medical devices);

(3)import and exportRights (if there is no qualified import/export company to act as an import agent)

(4) Medical device registration form.

(4) Medical Device Registration Certificate.