Article 10 Inspection and quarantine institutions shall, according to the risk level of imported medical devices and the classification of importing units, and in accordance with the relevant provisions of the General Administration of Quality Supervision, Inspection and Quarantine, implement an inspection and supervision mode combining on-site inspection of imported medical devices with follow-up supervision and management (hereinafter referred to as supervision and inspection).

Article 11 The General Administration of Quality Supervision, Inspection and Quarantine classifies imported medical devices into three risk levels: high risk, high risk and general risk according to their structural characteristics, use forms, use conditions, relevant provisions of national medical device classification and the needs of import inspection management.

The Catalogue of Risk Grades of Imported Medical Devices shall be determined and adjusted by the AQSIQ and published 60 days before the implementation date.

Article 12 Imported medical device products that meet the following conditions are of high risk level:

(1) Medical devices implanted in human body;

(2) Active medical devices involving the human body;

(3) Medical devices used to support and maintain life;

(4) Medical imaging equipment and energy therapy equipment that are potentially dangerous to human body;

(five) the product quality is unstable, and major quality accidents have occurred many times, and its safety and effectiveness must be strictly controlled.

Article 13 The risk level of imported medical device products meeting the following conditions is relatively high:

(a) Passive medical equipment involving the human body;

(two) other active medical devices that are not in contact with the human body;

(3) Medical devices with unstable product quality and recurring quality problems whose safety and effectiveness must be strictly controlled.

Article 14 Imported medical devices that are not included in the high-risk or high-risk level belong to the general risk level.

Fifteenth imported high-risk medical devices shall be inspected and managed in the following ways:

(a) a class of imported units, the implementation of on-site inspection and supervision and inspection, the annual batch of on-site inspection rate of not less than 50%;

(two) two or three types of imported units, the implementation of batch on-site inspection.

Article 16 The import of high-risk medical devices shall be subject to inspection management in the following ways:

(1) The annual batch on-site inspection rate of Class I importers shall not be less than 30%;

(2) The annual batch on-site inspection rate shall not be less than 50% if imported by Class II importers;

(three) three types of imported units, the implementation of batch on-site inspection.

Seventeenth imported general risk medical devices, the implementation of on-site inspection and supervision and inspection of the inspection management, of which the annual batch of on-site inspection rate is:

(1) The annual batch on-site inspection rate shall not be less than10% if imported by Class I importers;

(2) The annual batch on-site inspection rate shall not be less than 30% if imported by Class II importers;

(3) For Class III importers, the annual batch on-site inspection rate shall be no less than 50%.

Article 18 As required, AQSIQ may organize the supervision of manufacturing, pre-shipment inspection and loading supervision of high-risk imported medical devices according to foreign trade contracts.

Article 19 When imported medical devices are imported, the consignee of the imported medical devices or its agent (hereinafter referred to as the inspection applicant) shall apply for inspection at the inspection and quarantine institution at the customs declaration place and provide the following materials:

(a) Check the documents required in the requirements;

(two) medical devices belonging to the catalogue of compulsory product certification shall provide the compulsory certification certificate of China;

(three) the registration certificate of imported medical devices approved by the drug supervision and administration department of the State Council;

(4) If the importer is a Class I or Class II importer, the importer classification certificate issued by the inspection and quarantine institution shall be provided.

Article 20 The port inspection and quarantine institution shall examine the inspection data and notify the inspection applicant if it does not meet the requirements. If it meets the requirements after inspection, a Customs Clearance Form for Inbound Goods shall be issued. After the goods have gone through the formalities of customs declaration, they shall report to the inspection and quarantine organ for inspection in time.

Article 21 Imported medical devices shall be inspected at the destination declared by the inspector at the time of inspection.

For imported medical devices that need to be inspected in combination with installation and debugging, the place of use shall be designated during inspection, and the inspection and quarantine institution at the place of use shall conduct inspection. The catalogue of imported medical devices that need to be inspected in combination with installation and debugging shall be promulgated and implemented by the AQSIQ.

Special products such as implantable medical devices shall be inspected at the inspection and quarantine institutions designated by the AQSIQ.

Article 22 Inspection and quarantine institutions shall inspect imported medical devices in accordance with the mandatory requirements of national technical specifications; If the mandatory requirements of the national technical specifications are not formulated, the inspection can be carried out with reference to the relevant foreign standards designated by the AQSIQ.

Article 23 The contents of on-site inspection, supervision and inspection of imported medical devices by inspection and quarantine institutions may include:

(1) Verify the conformity of products with relevant certificates;

(2) quantity, specification, model and appearance inspection;

(three) inspection of packaging, labels and signs, such as the use of wooden packaging, should be quarantined;

(4) Verification of instructions and accompanying documents;

(five) mechanical, electrical, electromagnetic compatibility and other safety inspections;

(six) radiation, noise, biochemical and other health checks;

(seven) the inspection of environmental protection such as the discharge and residue of toxic and harmful substances and materials;

(eight) to test the performance of medical devices involved in diagnosis and treatment;

(9) Verification of product identification, marks and Chinese instructions.

Article 24 Inspection and quarantine institutions shall, in accordance with the compulsory product certification system and the relevant standards stipulated by the state, conduct entry verification on the imported medical devices subject to the compulsory product certification system, check the documents, check the conformity of the certificates and goods, and if necessary, take samples and send them to designated laboratories for testing.

Article 25 If the imported medical devices are not found to be unqualified after inspection, the inspection and quarantine institution shall issue an inspection and quarantine certificate for the imported goods.

If it is found unqualified after inspection, the inspection and quarantine institution shall issue a notice of inspection and quarantine treatment, and if it is necessary to claim compensation, it shall issue an inspection certificate. Where articles related to personal safety, health and environmental protection are unqualified, or articles that can be technically treated are still unqualified after technical treatment, the inspection and quarantine institution shall order the parties concerned to destroy them, or return the goods and notify the customs in writing, and report to the AQSIQ at the same time.