(3) As for the import by a Category C importer, the spot inspection of each batch shall be performed.

Article 17 With respect to the import of ordinary risk medical devices, the spot inspection shall be performed combining with surveillant inspection, and the annual rates of spot inspection of batches shall be as follows respectively:

(1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 10 percent;

(2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; and

(3) As for the import by a Category C importer, the annual rate of spot inspection of batches shall not be lower than 50 percent.

Article 18 The GAQSIQ may, if necessary, arrange the production supervision, pre-shipment inspection and installment surveillance over the imported high risk medical devices as agreed in a foreign trade contract.

Article 19 Where the medical devices are imported, the consignee or its agent of the imported medial devices (hereinafter referred to as the inspection applicants) shall apply for inspection to the IQ organ at the place where the customs declaration is made, and file the following materials as well:

(1) Documents as required in the rules of inspection application;

(2) Certificate of China Compulsory Certification for the medical devices within the Catalogue of Products Subject to the Compulsory Product Certification;

(3) Registration certificate of imported medical devices as examined, approved and registered by the administrative authority of drug supervision of the State Council; and

(4) Certificate documents concerning importer category as issued by an IQ organ for a Category A or B importer.

Article 20 A port IQ organ shall examine the inspection application materials and inform the inspection applicants if the requirements are not satisfied; in the case of any satisfied requirements upon examination, it shall issue an Inbound Goods Notice, and the importer shall timely apply for inspection to the IQ organ after the goods have gone through the formalities of customs declaration.

Article 21 The imported medical devices shall be inspected at the destination where the the inspection applicants declare when making inspection declaration.

With respect to the imported medical devices that need the inspection combining with their installments and adjustments, the use place thereof shall be specified when the inspection declaration is made, and the inspection shall be implemented by the IQ organ at the use place. The GAQSIQ shall publicize and implement the catalogue of imported medical devices that need the inspection combining with their installments and adjustments.

The inspection of special products such as the implantable medical devices shall be performed by an IQ organ as appointed by the GAQSIQ.

Article 22 An IQ organ shall implement the inspection on imported medical devices in accordance with the compulsory requirements of the state technical specifications; in case the said requirements have not been constituted yet, it may perform the inspection with reference to the relevant foreign criteria as designated by the GAQSIQ.

Article 23 The spot inspection and surveillant inspection of imported medical devices by an IQ organ may include:

(1) Verifications on the consistency between the products and the relating certificates;

(2) Examinations on the quantity, specifications and type, and appearance;

(3) Inspections on packaging, labels and signs, and quarantine if wooden packaging is adopted;

(4) Examinations on users?manuals and documents and materials attached to the devices;

(5) Inspections on machinery, electric, electromagnetic compatibility and other aspects of safety;

(6) Inspections on radiation, noise, biochemistry and other aspects of sanitation;

(7) Inspections on emission and residue of toxic and hazardous substances, materials and other aspects of environmental protection;

(8) Inspections on performance of medical devices involving the diagnosis and treatment; and

(9) Examinations on product logos, signs and users?manuals in Chinese.

Article 24 With respect to the imported medical devices that are subject to the compulsory product certification system, an IQ organ shall perform an inbound inspection on the certificates, examine the documents, check the consistency between the certificates and goods, and draw a sample of the goods, if necessary, which shall be sent to the designated laboratory for testing in light of the compulsory product certification system and relevant standards of the state.

Article 25 In case no unqualified imported medical device is found in the inspection, a Certificate of Inspection and Quarantine of Inbound Goods shall be issued by an IQ organ.

If any unqualified imported medical device is found in the inspection, an IQ organ shall issue a Circular of Inspection and Quarantine Treatment, and shall issue an inspection certificate if a claim for damage is necessary. Where any item involving the human safety, health or environmental protection is unqualified or any item that may be technically treated still remains unqualified upon the technical treatment, the party concerned shall be ordered by an IQ organ to destroy the item or return the goods, the customs shall be notified in written form, and it shall be reported to the GAQSIQ.

Chapter IV Inspection and Supervision on Imported Donated Medical Devices

Article 26 The imported donated medical devices shall not be used before, and shall not carry any article harmful to the environment or to the sanitation, or any other illegal or prohibited articles.

Article 27 No article within the Catalogue of Goods Prohibited From Being Imported of China may be carried with any imported donated medical devices.

Article 28 Any donating institution outside the territory of China that donates medical devices to China must apply by itself or by its agent in the territory of China to the GAQSIQ for going through the formalities of filing the donating institution and donated medical devices.

Article 29 The GAQSIQ may arrange the pre-inspection on the imported donated medical devices before the shipment thereof, if necessary.

Article 30 Any entity or its agent that accepts the imported donated medical devices shall make an inspection declaration to the IQ organ at the place where the declaration to customs is made upon relevant approving documents, and apply for inspection to the IQ organ at the place where the said devices are used.

The IQ organ shall accept the inspection declaration upon the relevant valid approving documents, and shall perform the port inspection and use place inspection accordingly.

Article 31 Only after the medical devices donated from outside the territory of China have been inspected to be qualified by the IQ organ inspects and a Certificate for Inspection and Quarantine of Inbound Goods has been issued, the donee may use the said devices; in the case of any unqualified devices after inspection, they shall be handled in accordance with the relevant provisions in the Inspection Law and the implementation rules thereof.

Chapter V Risk Warning and Fast Response

Article 32 The GAQSIQ shall set up a risk warning mechanism for imported medical devices. It shall issue warning information under relevant provisions and adopt corresponding risk warning measures and fast response measures by collecting and assessing information concerning the defective imported medical devices.

Article 33 An IQ organ shall be aware of the information relating to the quality of imported medical devices as used within its jurisdiction at regular intervals, and report to the GAQSIQ timely if any major quality accident concerning imported medical devices is found.

Article 34 Where the producer, importer or user finds any defect in the medical device, they shall report to the IQ organ and cooperate with the IQ organ in the risk warning measures and fast response measures.

Article 35 As for any defective imported medical device, the risk warning measures shall include:

(1) Releasing the risk warning bulletin to the IQ organs, and intensifying the inspection supervision on the medical devices as produced by the defective product producers and imported by the importers;

(2) Releasing the risk warning bulletin to the producers and importers of the defective products, and pressing them to take relevant measures to eliminate the risks in a timely manner;

(3) Releasing the risk warning bulletin to the consumers and users, and giving them a warning of the risks and harms of the defective imported medical devices; and

(4) Reporting relevant information to the related domestic Chinese authorities, foreign embassies or liaison offices of relevant countries and regions in China as well as relevant international organizations and institutions, and proposing necessary measures.

Article 36 As for the defective imported medical devices, the fast response measures shall include:

(1) Suggesting suspension of using the defective medical devices;

(2) Adjusting the category of the importer of the defective medical devices in the classified management;

(3) Stopping import of the defective medical devices;

(4) Suspending or revoking the certificates of state compulsory product certification for the defective imported medical devices; and

(5) Other necessary measures.

Chapter VI Supervision and Management

Article 37 The IQ organs shall implement supervisory examination on a Category A or B importer at least once per year, and may degrade the importer in light of the seriousness of any of the following circumstances:

(1) The importer has a bad credibility record;

(2) The medical devices as imported by this importer have severe potential risks in safety or serious quality problem;

(3) The unqualified import batches of the importer are up to 10 percent of the annual import batches upon inspections by the IQ organs,;

(4) The annual import batches of the importer fails to satisfy the requirements; or

(5) Otherwise the importer is in violation of any law or administrative regulation.

The degraded importer may lodge an application for resuming the original category in the classified management only after 12 months, and it must be reexamined, checked and approved, and publicized.

Article 38 The IQ organ, upon the approval of its principal, may seize or detain any imported medical devices under the following circumstances, except for those subject to the customs supervision:

(1) Prohibited from import;

(2) Any defectiveness in safety and sanitation or any potential health or environmental pollution risks; or

(3) Any possible circumstance that may harm the life or property safety of the doctor or patient and the situation is emergent.

Article 39 The GAQSIQ shall take the responsibility of training and examining qualifications of IQ organ staff for the administration of inspection and supervision on imported medical devices. The staff unqualified the examination shall not conduct the administration of inspection and supervision on imported medical devices.

Article 40 The used medical devices for scientific research or other non-applied-to-patient purposes may be imported only upon the approvals of the GAQSIQ and other relevant authorities.

With respect to any medical device as reproduced by the original factory, if it satisfies the requirements that new medical devices shall satisfy in safety and technology and comply with other relevant provisions of the state, it may be imported only upon the qualification assessment by the IQ organ and the approval of the GAQSIQ.

The used medical devices other than those in the two preceding paragraphs shall be prohibited from being imported.

Chapter VII Legal Liabilities

Article 41 Where anyone sells or uses the imported medical devices that are subject to the compulsory inspection and fails to apply for inspection or to go through inspection, or sells or uses the imported medical devices that fail to be applied for import verification that it should do, it shall be confiscated of the illegal income by an IQ organ, and be imposed upon a fine of no less than 5 percent but not more than 20 percent of the value of commodities; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws.

Article 42 Where anyone sells or uses the imported medical devices that are unqualified after the statutory inspection, sample inspection or verification, it shall be ordered by an IQ organ to stop sales or use, its illegal income and illegally sold or used commodities shall be confiscated, and shall be imposed upon a fine of the value of the commodities or not more than three times the value of commodities as sold or used illegally; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws.

Article 43 Where any importer of medical devices imports the used medical devices that are forbidden from being imported by the state, it shall return or destroy the said devices in accordance with the relevant provisions of the state. In case the imported used medical devices are electromechanical products and the circumstances are severe, it shall be concurrently imposed upon a fine of not more than 1 million yuan by an IQ organ.

Article 44 Where any staff of an IQ organ abuses his/her powers, deliberately creates difficulties, plays favoritism and engages in malpractice, forges inspection results, neglects their duties or delays the inspection and issuance of certificate, he/she shall be imposed upon an administrative punishment; if any crime is constituted, the criminal liability shall be investigated in accordance with relevant laws.

Chapter VIII Supplementary Rules

Article 45 The imported medical devices as referred to in these Measures are the machineries, equipment, apparatuses, materials or other articles, including the relevant software, that are brought into the territory of the People's Republic of China from overseas and applied separately or in combination to the human body, in order to do the prevention, diagnosis, treatment, care or mitigation of diseases, the diagnosis, treatment, care, mitigation and repair of injuries and disabilities, the research, substitution and adjustment in anatomy or physiological process, the control over pregnancy, etc.

The defective imported medical devices as referred to in these Measures are the imported medical devices that fail to comply with the provisions of state compulsory standards or have unreasonable dangers to the human body or property safety.

The importer as referred to in these Measures is an enterprise within the territory of China that shall be qualified as a legal person and has signed and implemented a foreign trade contract on medical device import or has entrusted a foreign-trade agent to import medical devices.

Article 46 These Measures shall be applicable to the medical devices that are brought into bonded areas, export procession zones or other customs supervision areas for use from outside the territory of China, and the medical devices that are brought into other areas within the territory of China from bonded areas, export procession zones or other customs supervision areas.

Article 47 The imported medical devices used for animals shall be governed by these Measures by analogy.

Article 48 In case any imported medical devices are the boiler pressure vessels, the safety surveillant inspection thereof shall observe other relevant provisions of the GAQSIQ. The imported medical devices subject to the Catalogue for the Model Examination of the Imported Measurement Devices of the People's Republic of China shall follow the laws and administrative regulations on measurement of the state.

Article 49 The GAQSIQ shall be responsible for interpreting these Measures.

Article 50 These Measures shall come into force as of December 1, 2007.

(Not the official translation. Source: www.fdi.gov.cn)