Chapter I General Rules
Article 1 These Measures are formulated according to the Law on the Inspection of Imported and Exported Commodities of the People's Republic of China (hereinafter referred to as the Inspection Law) and its implementing regulation and other relevant laws and administrative regulations for the purpose of strengthening the administration of inspection and supervision of the imported medical instruments and safeguarding the human health and life safety.
Article 2 These Measures shall be applicable to: (1) classified management of the medical instrument importers; (2) inspection surveillance of the imported medical instruments; and (3) risk warning and fast response management of the imported medical instruments.
Article 3 The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as the GAQSIQ) administers the inspection and supervision of the imported medical instruments all over the country, and shall take the responsibility of organizing, gathering and processing relevant risk information concerning the imported medical instruments, assessing the risks, and adopting the risk warning and fast response measures as well. The local entry-exit inspection and quarantine organs as established by the GAQSIQ (hereinafter referred to as the IQ organs) shall administer the inspection and supervision of the imported medical instruments within their jurisdictions respectively, and shall take the responsibility of gathering relevant risk information concerning the imported medical instruments, and implementing fast response measures.
Chapter II Classified Surveillance of Medical Instrument Importers
Article 4 The IQ organs shall perform the classified surveillance over the medical instrument importers according to the level of management and credibility thereof and the risk level, quality and import scale of the imported medical instruments, and there are three categories specifically. A medical instrument importer may voluntarily apply for classified management as required by their conditions.
Article 5 The importers in Category A shall satisfy the requirements as follows: (1) It shall severely observe the Inspection Law and its implementing regulation, other relevant laws and administrative regulations of the state as well as the relevant provisions of the GAQSIQ, shall have high credibility without any bad record for five successive years; (2) It shall have a sound management system quality, have already obtained a certification for the ISO9000 quality system, and have sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, etc.; (3) It shall have more than two quality management staff that have been through training by an IQ organ, are aware of basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China; (4) It shall have obtained relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent; (5) It shall have a good quality reputation when engaging in the business of the imported medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the liability of product quality over the last two years; (6) It shall have been engaged in import business of the medical instrument for at least six successive years, and be able to provide relevant certificate documents; (7) It shall have no less than 30 batches of imports for each year in the last two years; (8) It shall have collected and preserved the national and industrial standards for relevant medical instruments and the regulations and rules as well as the exclusive provisions concerning medial instruments, and have established and preserved fairly complete data archives regarding the imported medical instruments, with a preservation period of no less than 10 years; (9) It shall have the capabilities of technical training and after sales service that is appropriate for the imported medical instruments, or have an agreement of acquiring technical support by a third party; and (10) It shall have relatively independent business premises and storage conditions that is appropriate for the scope and scale of the imported medical instruments.
Article 6 The importers in Category B shall satisfy the requirements as follows: (1) It shall be in strict accordance with the Inspection Law and its implementation rules, other relevant laws and regulations of the state and the relevant provisions of the GAQSIQ, have a relatively high credibility, and without any bad record for three successive years; (2) It shall have a sound quality management system and sound quality management system including the import declaration, inspection and acceptance of import goods, storage, quality follow-up, defect report, and etc.; (3) It shall have more than one quality management staff that have been through training by an IQ organ, are aware of the basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical instruments in China; (4) It shall have obtained the relevant certificate documents, if it engages in the import business of medical instruments under the compulsory product certification system by itself or as an agent; (5) It shall have a good quality reputation when engaging in the import business of the medical instruments by itself or as an agent, and have no recall, claim for damage or any other accident because of the product quality liability within a year; (6) It shall have been engaged in the import business of the medical instrument for at least three successive years, and be able to provide relevant certificate documents; (7) It shall have no less than 10 batches of imports for each year in the last two years; (8) It shall have collected and preserved the national and industrial standards for relevant medical instruments and the regulations and rules and the exclusive provisions concerning medial instruments, and have established and preserved fairly complete data archives regarding the imported medical instruments, with a preservation period of no less than 10 years; (9) It shall have the capabilities of the technical training and after sales service that are appropriate for the imported medical instruments, or have an agreement of obtaining technical support by a third party; and (10) It shall have relatively independent business premises that are appropriate for the scope and scale of the imported medical instruments.
Article 7 The importers in Category C shall comprise: (1) Importers that have been engaged in the import business of medical instrument for less than three years; (2) Importers that have been engaged in the import business of the medical instrument for three years but fails to bring an application for the classified management; and (3) Importers that have brought an application for the classified management but not listed in the Category A or B management because of failing to satisfy the requirements for the importers in Category A or B upon examination.
Article 8 Where a medical instrument importer applies for a Category A or B importer (hereinafter referred to as the applicant), it shall submit an application to the administration of inspection and quarantine directly under the GAQSIQ at the place where the applicant is situated, and submit the materials as follows: (1) An application in written form with a signature of the authorized person and the official seal thereon; (2) Legal person business license and medical instrument business enterprise permit; (3) Quality management system (QMS) certificate and quality management documents; (4) Certificate documents as granted by an IQ organ to the quality management staff after training; (5) Certificate materials on the number of import batches in the last two years; and (6) Statement as promised to observe the relevant laws and administrative regulations of the state and the principle of providing true materials (self-statement).
Article 9 The administration of inspection and quarantine directly under the GAQSIQ shall complete the assessment on written application as submitted by an applicant within five workdays; in case the application materials are incomplete, the applicant shall make supplement as required. As for an application for a Category A importer, the administration of inspection and quarantine directly under the GAQSIQ shall arrange the spot assessment after completing the assessment on written application, and shall submit the result of assessment and relevant materials to the GAQSIQ if the assessment is passed. The GAQSIQ shall verify and approve an applicant that satisfies the requirements for a Category A importer, and publicize the list of Category A importers at regular intervals. As for an application for a Category B importer, the administration of inspection and quarantine directly under the GAQSIQ may arrange the spot assessment by itself or entrusting the IQ organ at the place where the importer is situated after completing the assessment of written application. If the assessment is passed, the applicant shall be verified and approved by the administration of inspection and quarantine directly under the GAQSIQ shall and shall be submitted to the GAQSIQ for filing. The administration of inspection and quarantine directly under the GAQSIQ shall take the responsibilities of publicizing the list of Category B importers at regular intervals.
Chapter III Risk Levels and Inspection Supervision of Imported Medical Instruments
Article 10 In accordance with the relevant provisions of the GAQSIQ, an IQ organ shall take the spot inspection and supervision on the imported medical instruments combining with the follow-up surveillance and management (hereinafter referred to as the surveillant inspection) on the basis of the risk levels of the imported medical instruments and the categories of the importers.
Article 11 The GAQSIQ shall divide the risks of the imported medical instruments into three risk levels: high risk, relatively high risk and ordinary risk in light of the structural features, use forms and use conditions of the imported medical instruments as well as relevant rules on the categorization of medical instruments of the state, requirements for the import inspection management, etc.. The GAQSIQ shall make adjust the catalogue of the risk levels of the imported medical instruments and shall publicize it 60 days prior to the date of implementation of the catalogue.
Article 12 Any imported medical instrument that satisfy the following requirements shall be at a level of high risk: (1) Any medical instrument implanted into the human body; (2) Any powered medical instrument intervening in the human body; (3) Any medial instrument used for the life support or life maintenance; (4) Any medical image equipment and energy treatment equipment that may have potential dangers to the human body; and (5) Any medical instrument that are unstable in product quality, have led to major quality accidents for several times, and must be controlled rigidly in product safety and effectiveness.
Article 13 Any imported medical instrument that satisfy the following requirements shall be at a level of relatively high risk: (1) Any unpowered medical instrument intervening in the human body; (2) Any other powered medical instrument contacting the human body but not at the level of high risk; and (3) Any medical instrument that are unstable in product quality, have led to quality problems for several times, and must be controlled rigidly in product safety and effectiveness.
Article 14 Any other imported medial instruments that are not listed in the levels of high risk and relatively high risk shall be at the level of ordinary risk.
Article 15 With respect to the import of high risk medical instruments, the inspection and management shall be performed in the modes as follows: (1) As for the import by a Category A importer, the spot inspection shall be performed combining with surveillant inspection, and the annual rate of spot inspection of batches shall not be lower than 50 percent; and (2) As for the import by a Category B or C importer, the spot inspection of each batch shall be performed.
Article 16 With respect to the import of relatively high risk medical instruments, the inspection and management shall be performed in the following modes as follows: (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 50 percent; and (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 instruments, 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, as required, arrange the production supervision, pre-shipment inspection and installment surveillance over the imported high risk medical instruments as agreed in a foreign trade contract.
Article 19 Where the medical instruments are imported, the consignee or its agent of the imported medial instruments (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 instruments within the Catalogue of Products Subject to the Compulsory Product Certification system; (3) Registration certificate of imported medical instruments 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 customs 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 a Circular of Customs Clearance of Inbound Goods, 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 instruments shall be inspected at the destination where the inspection declaration is made by the inspection applicants. With respect to the imported medical instruments that require 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 instruments that require the inspection combining with their installments and adjustments. The inspection of the special products such as the implanted medical instruments shall be performed by an IQ organ as appointed by the GAQSIQ.
Article 22 An IQ organ shall implement the inspection on imported medical instruments 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 criterions as designated by the GAQSIQ.
Article 23 The spot inspection and surveillant inspection of imported medical instruments 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 user's manuals and documents and materials attached to the instruments; (5) Inspections on machinery, electric and electromagnetic compatibility and other aspects of safety; (6) Inspections on radiation, noise, biochemistry and other aspects of sanitation; (7) Inspections on emission, residue and materials of toxic and hazardous substances and other aspects of environmental protection; (8) Inspections on performance of medical instruments involving the diagnosis and treatment; and (9) Examinations on product logos, signs and user's manuals in Chinese.
Article 24 With respect to the imported medical instruments 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 instrument 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 instrument 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 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 Supervision on Imported Donated Medical Instruments
Article 26 The imported donated medical instruments shall not be used before, and shall not carry any article harmful to the environment or to the sanitation, or any other illegal imports.
Article 27 No article within the Catalogue of Goods Prohibited from Being Imported of China may be carried with any imported donated medical instruments.
Article 28 Any donating institution outside the territory of China that donates medical instruments to China by itself or by its agent in the territory of China must apply to the GAQSIQ for going through the formalities of filing the donating institution and donated medical instruments.
Article 29 The GAQSIQ may arrange the pre-inspection on the imported donated medical instruments before the shipment thereof, if necessary.
Article 30 Any entity or its agent that accepts the imported donated medical instruments shall make an inspection application 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 instruments are used. The IQ organ shall accept the inspection application upon the relevant valid approving documents, and shall perform the customs inspection and use place inspection accordingly.
Article 31 After the IQ organs inspect the medical instruments donated from outside the territory of China have been inspected to be qualified and a Certificate for Inspection and Quarantine of Inbound Goods has been issued by, the donee may use the said instruments; in the case of any unqualified inspection, they shall be handled in accordance with the relevant provisions in the Inspection Law and the implementation regulations thereof.
Chapter V Risk Warning and Fast Response
Article 32 The GAQSIQ shall set up a risk warning mechanism for imported medical instruments, it shall issue warning information under relevant provisions and adopt corresponding risk warning measures and fast response measures by collecting and assessing the information concerning the defective imported medical instruments.
Article 33 An IQ organ shall be aware of the information relating to the quality of imported medical instruments as used within its jurisdiction at regular intervals, and report to the GAQSIQ timely, if any major quality accident concerning imported medical instruments is found.
Article 34 Where any defect in the medical instrument is found by the producer, importer or user thereof, it shall be reported to the IQ organ, and assistance shall be made in the risk warning measures and fast response measures taken by the IQ organ.
Article 35 As for any defective imported medical instrument, the risk warning measures shall include: (1) releasing the risk warning bulletin to the IQ organs, and intensifying the inspection supervision on the medical instruments 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 avoid 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 troubles of the defective imported medical instruments; and (4) reporting relevant information to the related domestic authorities, China embassies or liaison offices in relevant countries and regions, and to relevant international organizations and institutions, and proposing necessary measures.
Article 36 As for the defective imported medical instruments, the fast response measures shall include: (1) suggesting the suspension of using the defective medical instruments; (2) adjusting the category of the importer of the defective medical instruments in the classified management; (3) stopping the import of the defective medical instruments; (4) suspending or invalidating the certificates of state compulsory product certification for the defective imported medical instruments; and (5) other necessary measures.
Chapter VI Supervision and Management
Article 37 The IQ organs shall implement the supervisory examination on a Category A or B importer at least one time 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 instruments 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 an IQ organ,; (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 instruments under the following circumstances, except for those subject to the customs supervision: (1) prohibited importations; (2) any defectiveness in safety and sanitation or any possible potential health risks or environmental pollution; or (3) any possible circumstance that may harm the life or property safety of the doctor or patient or any emergency.
Article 39 The GAQSIQ shall take the responsibility of training and examining a qualification of IQ organs staff for the administration of inspection and supervision on imported medical instruments. The staff without examination to be qualified shall not conduct the administration of inspection and supervision on imported medical instruments.
Article 40 The used medical instruments 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 instrument as reproduced by the original factory, if it satisfies the requirements that new medical instruments shall satisfy in safety and technology and comply with other relevant provisions of the state, may be imported only upon the qualification assessment by the IQ organ and the approval of the GAQSIQ. The used medical instruments other than those in the two preceding paragraphs shall be prohibited from being imported.
Chapter VII Legal Liability
Article 41 Where any importer sells or uses the imported medical instruments that is subject to the statutory inspection and fails to apply for the inspection or to go through the inspection, or it sells or uses the imported medical instruments that fails to be applied for the import verification that it should be, it shall be confiscated of the illegal income by an IQ organ, and be imposed upon a fine of 5 percent or 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 any importer sells or uses the imported medical instruments 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 it shall be imposed upon a fine of the value 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 instruments imports the used medical instruments that are forbidden from being imported by the state, it shall return or destroy the said instruments in accordance with the relevant provisions of the state. In case the imported used medical instruments are electromechanical products and the circumstances are severe, it shall be concurrently imposed upon a fine of not more than RMB one 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 commits irregularities, forges inspection results, neglects their duties or delays the inspection and issuance of certificate, it 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 instruments as referred to in these Measures are the machineries, equipments, apparatuses, materials or other articles, including the relevant software, that are brought into the territory of 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 instruments as referred to in these Measures are the imported medical instruments 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 instrument import or has entrusted a foreign-trade agent to import medical instruments.
Article 46 These Measures shall be applicable to the medical instruments that are brought into bonded area or export procession zone or other customs supervision areas for use from outside the territory of China, and the medical instruments that are brought into other areas within the territory of China from bonded area or export procession zone or other customs supervision areas.
Article 47 The imported medical instruments for animals shall be governed by these Measures by analogy.
Article 48 In case any imported medical instruments are the boiler pressure vessels, the safety surveillant inspection thereof shall observe other relevant provisions of the GAQSIQ. The imported medical instruments within the Catalogue for the Model Examination of the Imported Measurement Instruments of the People's Republic of China shall follow the laws and administrative regulations on measurement of the state.
Article 49 The power to interpret these Measures shall remain with the GAQSIQ.
Article 50 These Measures shall come into force as of December 1, 2007. |
