Decoding Imported Medical Devices: Regulations, Standards, and Common Issues

ImportMedical EquipmentIt is not just an exchange of goods, but also a strict assessment of regulations, standards, and safety. Here, we will dissect the import process and common problems of medical devices for you.

1、Background:In recent years, medical devices have become a hot consumer item, especially various epidemic prevention supplies after the COVID-19 pandemic.
2、Definition:According to the Regulations on the Supervision and Administration of Medical Devices, medical devices mainly refer to various types of instruments, equipment, etc. used on the human body, and their effectiveness is mainly obtained through physical and other means.

1、Basic Regulations:
(1) Law of the Peoples Republic of China on Commodity Inspection: It stipulates the inspection standards and procedures for import and export commodities.import and export(2) Regulations for the Implementation of the Law of the Peoples Republic of China on Import and Export Commodity Inspection: It clarifies the specific implementation rules of the inspection law.
(3) Regulations on the Supervision and Administration of Medical Devices: It comprehensively stipulates the supervision and management of medical devices.
2、Classification Management:

According to the Regulations on the Supervision and Administration of Medical Devices, the state implements classification management of medical devices. Class I medical devices need to be filed, while Class II and Class III medical devices need to be registered and product risk analysis materials need to be submitted.3、Related Announcements and Guidelines:

(1) Announcement on Strengthening the Supervision and Management of Imported Donated Medical Devices: It specially manages imported donated medical devices.
(2) Announcement on the Implementation of Online Verification of 7 Regulatory Certificates such as the Customs Clearance Certificate for Imported Drugs: It verifies the customs clearance certificates for imported drugs and medical devices.
(3) Catalogue of Old Mechanical and Electrical Products Prohibited from Import and Announcement on Adjusting the Inspection Institutions for Imported Cardiac Pacemakers: It clarifies the items prohibited from import and the inspection institutions for cardiac pacemakers.
1、No Medical Device Registration Certificate:

Some imported medical devices such as oral scanners and X-ray tube assemblies do not have relevant medical device registration certificates, which will lead to the customs determining them as unqualified and returning them.CIF (Cost, Insurance, and Freight)
2、Inconsistent information:
(1) Model issues: For example, the model of an imported dental comprehensive treatment machine does not match the model stated on its medical device registration certificate.
(2) Document issues: The enterprise is unable to provide the corresponding medical device registration certificate, or the provided registration certificate does not match the actual goods.
3、Label and certification issues:
(1) Chinese labels: Medical devices should be equipped with Chinese instructions and Chinese labels, and ensure compliance with the relevant regulations of the Regulations on the Supervision and Administration of Medical Devices.
(2) Compulsory product certification: Some medical devices, such as wet wipes, require a fumigation certificate issued by the exporting country. When imported medical devices are subject to compulsory product certification, relevant markings should be ensured.
4、Electrical safety performance:Imported medical devices need to comply with the requirements of GB 9706.1. For example, the steady - state input power of medical electrical equipment should not exceed 10% of the nominal value. In the dielectric strength test, the test voltage of dielectric strength should be determined based on the peak value of the working voltage.

1、Standard revision:GB 9706.1—2020标准已修订，并于2023年5月1日起实施。
2、Safety requirements:More detailed regulations have been made on the basic safety and performance of medical electrical equipment.
3、Technical revisions:Such as specific requirements for input power, requirements for test voltage of dielectric strength, the concept of altitude for creepage distance and electrical clearance, etc.

Importing medical devices is not a simple matter. However, as long as one strictly follows the regulations, pays attention to common problems, and keeps up with the latest standards, the import process can be ensured to proceed smoothly.