Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments

Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments Order of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (No.95) The Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments, which were deliberated and adopted at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on May 30, 2007, are hereby enacted, and shall be effective as of December 1, 2007. Director-general: Li Changjiang June 18, 2007 Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments Chapter I General Provisions Article 1 In order to strengthen the administration of inspection and supervision of the imported medical instruments and protect the human health and life safety, these Measures have been made in accordance with the Law on the Inspection of Imported and Exported Commodities of the People's Republic of China (the “Inspection Law”) and its implementing regulation and other relevant laws and administrative regulations. Article 2 These Measures shall apply to: (a) Categorized management of the medical instrument importers; (b) Inspection supervision of the imported medical instruments; and (c) Risk precaution and rapid 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 (the “GAQSIQ”) shall be in charge of the national administration of the inspection and supervision of the imported medical instruments, and be responsible for organizing, gathering and sifting the risk information in relation to the imported medical instruments, assessing the risks, and taking the risk precaution and rapid response measures. The local entry-exit inspection and quarantine agencies set up by the GAQSIQ (the “IQ agencies”) shall be responsible for the administration of the inspection and supervision of the imported medical instruments within their respective jurisdictions, and be responsible for organizing, gathering and sifting the risk information in relation to the imported medical instruments, assessing the risks, and implementing the risk precaution and rapid response measures. Chapter II Categorized Supervision of Medical Instrument Importers Article 4 On the basis of the level of management and credibility of the medical instrument importers and the risk level, quality and import scale of the imported medical instruments, the IQ agencies shall implement the categorized supervision of the medical instrument importers, specifically, three categories. According to its conditions, a medical instrument importer may voluntarily lodge an application for categorized management. Article 5 The importers in Category A shall meet the following conditions: (a) Strictly complying with the Inspection Law and its implementing regulation, other relevant laws and administrative regulations of the state and the relevant provisions of the GAQSIQ, enjoying a high degree of credibility, and without any bad record for five consecutive years; (b) Having a sound quality management system, having acquired the ISO9000 quality system certification, and having sound quality management rules covering the import declaration, inspection and acceptance of imports, storage, quality follow-up, defect report, etc.; (c) Having two or more quality management personnel who are qualified after training by an IQ agency, familiar with the basic technology, performance and structure of the relevant products, and have a knowledge of the administration of the inspection and supervision of the imported medical instruments in China; (d) Having acquired the relevant supporting certificates, if it deals, by itself or as an agent, in the imported medical instruments subject to the mandatory product certification system; (e) The imported medical instruments dealt in by itself or as an agent enjoy a good reputation of quality, and have no recall, claim for damage or any other accident due to the product quality liability over the last two years; (f) Having operated the medical instrument import business for at least 6 consecutive years, and able to provide relevant supporting certificates; (g) Having no less than 30 batches of imports each year, over the last two years; (h) Having gathered and kept the national and industrial standards for relevant medical instruments and the administrative regulations and rules and the special provisions on medial instruments, and having established and kept relatively complete data files on the imported medical instruments, with the period of keeping being no less than 10 years; (i) Having the technical training and aftersales service capabilities suitable for the imported medical instruments, or having agreed on the provision of technical support by a third party; and (j) Having relatively independent business premises and storage conditions suitable for the extent and scale of the imported medical instruments. Article 6 The importers in Category B shall meet the following conditions: (a) Strictly complying with the Inspection Law and its implementing regulation, other relevant laws and administrative regulations of the state and the relevant provisions of the GAQSIQ, enjoying a relatively high degree of credibility, and without any bad record for three consecutive years; (b) Having a sound quality management system and sound quality management rules covering the import declaration, inspection and acceptance of imports, storage, quality follow-up, defect report, etc.; (c) Having one or more quality management personnel who are qualified after training by an IQ agency, familiar with the basic technology, performance and structure of the relevant products, and have a knowledge of the administration of the inspection and supervision of the imported medical instruments in China; (d) Having acquired the relevant supporting certificates, if it deals, by itself or as an agent, in the imported medical instruments subject to the mandatory product certification system; (e) The imported medical instruments dealt in by itself or as an agent enjoy a good reputation of quality, and have no recall, claim for damage or any other accident due to the product quality liability within a year; (f) Having operated the medical instrument import business for at least 3 consecutive years, and able to provide relevant supporting certificates; (g) Having no less than 10 batches of imports each year, over the last two years; (h) Having gathered and kept the national and industrial standards for relevant medical instruments and the administrative regulations and rules and the special provisions on medial instruments, and having established and kept relatively complete data files on the imported medical instruments, with the period of keeping being no less than 10 years; (i) Having the technical training and aftersales service capabilities suitable for the imported medical instruments, or having agreed on the provision of technical support by a third party; and (j) Having relatively independent business premises suitable for the extent and scale of the imported medical instruments. Article 7 The importers in Category C shall include: (a) An importer having not operated the medical instrument import business for three years; (b) An importer having operated the medical instrument import business for three years but having not lodged an application for the categorized management; and (c) An importer having lodged an application for the categorized management but not listed in the Category A or B management due to a failure to meet the conditions for the importers in Category A or B after assessment. Article 8 A medical instrument importer applying for a Category A or B importer (the “applicant”) shall lodge an application with the administration of inspection and quarantine directly under the GAQSIQ at the place where the applicant is located, and submit the following materials: (a) A written application with the authorized signature and the official seal affixed thereon; (b) Legal person business license and medical instrument business enterprise permit; (c) Quality management system (QMS) certificate and quality management documents; (d) Supporting certificates on the quality management personnel who are qualified after training by an IQ agency; (e) Supporting certificates on the number of import batches over the last two......