Article X inspection and quarantine agencies in accordance with the risk level of imported medical devices, the classification of imported units, according to the relevant provisions of the State Administration of Quality Supervision, the implementation of on-site inspection of imported medical devices, as well as follow-up supervision and management (hereinafter referred to as supervision and inspection) combined with the inspection and supervision mode.
Article XI of the State Administration of Quality Supervision, according to the structural characteristics of imported medical devices, the use of forms, the use of conditions, the relevant rules of the national classification of medical devices as well as the need for import inspection and management of imported medical equipment products are divided into: high-risk, high-risk and general risk of three risk levels.
Imported medical devices risk level catalog by the AQSIQ to determine, adjust, and in the implementation of 60 days before the date of publication.
Article XII of the following conditions for the import of medical equipment products for high-risk level:
(1) implanted medical devices;
(2) intervention in the body of active medical devices;
(3) used to support, life-sustaining medical devices;
(4) potentially hazardous to the human body of the medical imaging equipment and energy treatment
(E) unstable product quality, repeated major quality incidents, the effectiveness of its safety must be strictly controlled medical devices.
Article XIII of the following conditions for the import of medical equipment products for higher risk level:
(a) intervention in the human body of passive medical devices;
(b) does not belong to the high-risk of other contact with the human body of the active medical devices;
(c) product quality is more unstable, the quality of the many occurrences of quality problems, the effectiveness of the safety of its must strictly control the medical device. The medical device.
Article XIV is not included in the high-risk, higher risk level of imported medical devices are general risk level.
Article XV of the import of high-risk medical devices, in accordance with the following manner of inspection and management:
(A) a class of imported units imported, the implementation of on-site inspection and supervision and inspection of a combination of ways, which the annual batch of on-site inspection rate of not less than 50%;
(B) two or three types of imports imported units, the implementation of on-site inspection of the batch.
Article XVI of the import of higher-risk medical devices, in accordance with the following inspection and management:
(A) a class of imported units imported, the annual batch on-site inspection rate of not less than 30%;
(B) two types of imports imported units, the annual batch on-site inspection rate of not less than 50%;
(C) three types of imports imported units imported, the implementation of a batch of On-site inspection.
Article XVII of the general risk of imported medical devices, the implementation of on-site inspection and supervision and inspection of a combination of inspection and management, in which the annual batch on-site inspection rate were:
(a) a class of imported units imported, the annual batch on-site inspection rate of not less than 10%;
(b) two types of imports imported units imported, the annual batch on-site inspection rate of not less than 30%
(C) three types of imported units imported, the annual batch on-site inspection rate of not less than 50%.
Article 18 According to the need, the AQSIQ high-risk imports of medical devices can be agreed in accordance with foreign trade contracts, the organization and implementation of supervision, pre-shipment inspection and supervision of loading.
Article XIX of imported medical devices imported, the consignee of imported medical devices or its agent (hereinafter referred to as the inspection) shall declare to the inspection and quarantine institutions, and provide the following materials:
(a) the inspection regulations require the provision of documents;
(b) belong to the "implementation of mandatory product certification of the product catalog" within the medical device, it should be Provide China Compulsory Certification;
(C) the State Council Drug Administration approval of the registration of imported medical devices registration certificate;
(D) the import unit for the first and second class of imported units, should provide the inspection and quarantine agencies to issue the classification of imported units to prove the document.
Article 20 of the port inspection and quarantine agencies shall review the inspection materials, does not meet the requirements, shall notify the inspection; after reviewing the requirements, the issuance of "Customs Clearance of Entry Goods", the goods for Customs clearance procedures, it should be timely to the inspection and quarantine institutions to apply for inspection.
Article 21 of the imported medical equipment shall be declared in the declaration of the inspection of the destination inspection.
The need to implement the test in conjunction with the installation and commissioning of imported medical devices, should be clear at the time of inspection, the use of inspection and quarantine institutions to implement the test. Need to be combined with the installation and commissioning of imported medical devices to implement the test directory published by the AQSIQ external implementation.
For implantable medical devices and other special products, should be designated by the AQSIQ inspection and quarantine institutions to implement the test.
Article 22 The inspection and quarantine agencies in accordance with the mandatory requirements of national technical specifications for the inspection of imported medical devices; has not yet been formulated the mandatory requirements of the national technical specifications, you can refer to the State Administration of Quality Supervision designated by the relevant foreign standards for inspection.
Article 23 The inspection and quarantine agencies to implement on-site inspection of imported medical devices and supervision and inspection may include:
(a) verification of the consistency of the product and the relevant certificates;
(b) the number, specifications, appearance of the inspection;
(c) packaging, labeling and labeling of the inspection, such as the use of wooden packaging, the implementation of quarantine shall be implemented;< /p>
(d) instructions, verification of random documentation;
(e) mechanical, electrical, electromagnetic compatibility and other safety inspections;
(f) radiation, noise, biochemistry and other health inspections;
(g) toxic and hazardous substances, emissions, residues, and materials and other environmental protection inspections;
(h) involves diagnosis, treatment, medical device performance inspection. Medical device performance test;
(ix) product identification, labeling and verification of Chinese instructions.
Article 24 The implementation of mandatory product certification system of imported medical devices inspection and quarantine agencies to implement entry verification, inspection of documents, check whether the goods match the certificate, if necessary, take samples sent to the designated laboratory, in accordance with the mandatory product certification system and the relevant state standards for testing.
Article 25 of the imported medical devices have not been found unqualified by the inspection, inspection and quarantine institutions shall issue "proof of entry inspection and quarantine of goods.
The inspection found unqualified, the inspection and quarantine institutions shall issue "inspection and quarantine treatment notice", the need for claims should be issued inspection certificate. Involving personal safety, health, environmental protection projects failed, or can be technically processed by the technical treatment of the project after the test is still unqualified, by the inspection and quarantine institutions shall order the parties to destroy, or return and inform the Customs and Excise Department in writing, and reported to the State Administration of Quality Supervision.