Related Introduction

is a highly regulated industry with corresponding laws.China implements risk classification and catalog management for medical devices,which are legally controlled commodities.Therefore,enterprises must understand medical deviceauthorities regulations and master import/export procedures.

Medical Device Import Regulatory Requirements

Import regulatory requirements

According to the Medical Device Supervision and Administration Regulations,imported medical devices must be registered or filed

Imported medical devices must have Chinese instructions and labels

Strictly prohibit importing expired,faulty,or obsolete medical devices

Obtain import licenses in advance as required

Key points for medical device import clearance are as follows:

Prepare basic reporting materials

After customs declaration,review corresponding filing/registration certificates

Inspection and Testing Institutions for Entry and Exit

Medical Device Export Regulatory Requirements

Export regulatory requirements

According to the Regulations on the Supervision and Administration of Medical Devices,enterprises exporting medical devices must ensure that the exported medical devices meet the requirements of the importing country (region).The quality of exported medical devices is regulated by the importing country.Therefore,Chinese customs generally does not conduct commercial inspections on exported medical devices.

However,after the outbreak of the pandemic,the following compliance risks should be noted for exporting medical devices:

If the medical device falls under the category of statutory inspection goods,it must still pass inspection by Chinese customs before export.

During entry and exit quarantine,if the medical device is a special item (such as an antibody test kit),an exit approval procedure must be completed.

Special attention should be paid to whether the medical device carries human genetic resources.

To summarize,the main areas of attention include the following:

Tax-related aspects: Tariff classification,origin and tariffs in the U.S.and Canada,special relationships,and royalty fees.

Inspection-related aspects: Statutory inspection,special items involving quarantine.

Certification-related aspects: Medical device registration/filing-related documents,individuals requiring import licenses,special items requiring quarantine approval.

Regulatory-related aspects: Whether physical items,technology,or software fall under import/export control items,biosafety and exit restrictions for human genetic resources.