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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 implementation rules and other relevant laws and administrative regulations for the purpose of strengthening the administration of inspection and supervision of the imported medical devices and safeguarding the human health and life safety.
Article 2 These Measures shall be applicable to:
(1) Classified management of the medical device importers;
(2) Inspection surveillance of the imported medical devices; and
(3) Risk warning and fast response management of the imported medical devices.
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 devices all over the country, and shall take the responsibility of organizing, gathering and processing relevant risk information concerning the imported medical devices, 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 devices within their jurisdictions respectively, and shall take the responsibility of gathering relevant risk information concerning the imported medical devices, and implementing fast response measures.
Chapter II Classified Supervision of Medical Device Importers
Article 4 The IQ organs shall perform classified surveillance over the medical device importers according to the level of management and credibility thereof and the risk level, quality and import scale of the imported medical devices, and there are three categories specifically.
A medical device 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 strictly observe the Inspection Law and its implementation rules, other relevant laws and administrative regulations of the state as well as the relevant provisions of the GAQSIQ, and shall have high credibility without any bad record for five successive years;
(2) It shall have a sound quality management system, have already obtained a certification for the ISO9000 quality system, and have sound quality management mechanisms including those on import declaration, inspection and acceptance of import goods, storage, quality tracking, defect report, etc.;
(3) It shall have more than two quality management staff members that have passed training by an IQ organ, well know basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical devices in China;
(4) It shall have obtained relevant certificate documents if it engages in the import business of medical devices 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 devices 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 medical device 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 collect and preserve national and industrial standards for relevant medical devices and the regulations and rules as well as the special provisions concerning medial devices, and shall establish and preserve fairly complete data archives regarding the imported medical devices with a preservation period of no less than 10 years;
(9) It shall have the capabilities of technical training and after-sale service appropriate for the imported medical devices, 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 are appropriate for the scope and scale of the imported medical devices.
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, and have a relatively high credibility without any bad record for three successive years;
(2) It shall have a sound quality management system and sound quality management mechanisms including import declaration, inspection and acceptance of import goods, storage, quality tracking, defect report, and etc.;
(3) It shall have more than one quality management staff member that have passed training by an IQ organ, well know the basic technology, performance and structure of the relevant products, and know the administration on the inspection and supervision of the imported medical devices in China;
(4) It shall have obtained the relevant certificate documents if it engages in the import business of medical devices 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 devices by itself or as an agent, and have no recall, claim for damage or any other accident because of the product quality liability within one year;
(6) It shall have been engaged in the import business of the medical devices 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 collect and preserve national and industrial standards for relevant medical devices and the regulations and rules and the special provisions concerning medial devices, and establish and preserve fairly complete data archives regarding the imported medical devices with a preservation period of no less than 10 years;
(9) It shall have the capabilities of technical training and after-sale service that are appropriate for the imported medical devices, 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 devices.
Article 7 The importers in Category C shall include:
(1) Importers that have been engaged in the import business of medical devices for less than three years;
(2) Importers that have been engaged in the import business of the medical devices for three years or above but have not brought an application for the classified management; and
(3) Importers that have brought an application for the classified management but are 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 device 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 located, and submit the materials as follows:
(1) An application in written form with signature of the authorizing person and the official seal thereon;
(2) Legal person business license and medical device 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 who pass 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 commitment to provide authentic materials (self-statement).
Article 9 The administration of inspection and quarantine directly under the GAQSIQ shall complete the examination on written application as submitted by an applicant within five workdays; in case the application materials are incomplete, it shall require the applicant to make supplement.
As for an application for a Category A importer, the administration of inspection and quarantine directly under the GAQSIQ shall arrange a spot assessment after completing the examination on written application materials, 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 a spot assessment by itself or entrusting the IQ organ at the place where the importer is located after completing the examination of written application materials. If the assessment is passed, the applicant shall be verified and approved by the administration of inspection and quarantine directly under the GAQSIQ 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 Devices
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 devices connecting the follow-up surveillance and management (hereinafter referred to as the surveillance inspection) on the basis of the risk levels of the imported medical devices and the categories of the importers.
Article 11 The GAQSIQ shall divide the risks of the imported medical devices 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 devices as well as relevant rules on the classification of medical devices of the state, requirements for the import inspection management, etc.
The GAQSIQ shall formulate and adjust the catalogue of risk levels of the imported medical devices and publicize it 60 days prior to the date of implementation of the catalogue.
Article 12 Any imported medical device that satisfies the following requirements shall be at the level of high risk:
(1) Any medical device implanted into the human body;
(2) Any active medical device intervening in the human body;
(3) Any medial device used for supporting or maintaining life;
(4) Any medical imaging equipment and energy treatment equipment that may have potential dangers to the human body; and
(5) Any medical device that has unstable product quality, has led to major quality accidents for several times, and must be controlled rigidly in product safety and effectiveness.
Article 13 Any imported medical device that satisfies the following requirements shall be at the level of relatively high risk:
(1) Any passive medical device intervening in the human body;
(2) Any other active medical device contacting the human body but not at the level of high risk; and
(3) Any medical device that has comparatively unstable product quality, has led to quality problems for several times, and must be controlled rigidly in product safety and effectiveness.
Article 14 Any other imported medial devices 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 devices, 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 devices, the inspection and management shall be performed in the 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
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