(a) the implementation of classification and management of medical device importers;
(b) the implementation of inspection and supervision of imported medical devices;
(c) the implementation of imported medical devices risk warning and rapid response management. Article III of the State General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as AQSIQ) in charge of the supervision and management of imported medical devices inspection, is responsible for organizing the collection and collation of imported medical devices and related risk information, risk assessment and take risk warning and rapid response measures.
AQSIQ in the entry-exit inspection and quarantine agencies around (hereinafter referred to as inspection and quarantine institutions) is responsible for the supervision and management of imported medical devices under the jurisdiction of the area, responsible for collecting and importing medical devices related to risk information and rapid response measures for specific implementation. Chapter II Classification and Supervision of Medical Device Importers Article IV The inspection and quarantine agencies based on the management level of medical device importers, integrity, imported medical device products, risk level, quality status and scale of imports, the implementation of classification and supervision of medical device importers, specifically divided into three categories.
Medical device importers can be based on the conditions of voluntary application for classification and management. Article a class of imported units should meet the following conditions:
(a) strict compliance with the Commodity Inspection Law and its implementing regulations, other relevant state laws and regulations, as well as the relevant provisions of the State Administration of Quality Supervision, high integrity, no bad record for five consecutive years;
(b) has a sound quality management system, ISO9000 quality system certification, with a sound quality management system Including import inspection, import acceptance, warehousing and storage, quality tracking and defect reporting system;
(C) has more than two qualified by the inspection and quarantine institutions trained quality management personnel, familiar with the basic technology, performance and structure of the relevant products, understanding of China's supervision and management of the inspection and management of imported medical devices;
(D) agent or business implementation of mandatory product certification system Imported medical equipment products, should obtain the appropriate documents;
(E) agent or business of imported medical equipment product quality reputation, 2 years did not occur due to product quality responsibility for the return of the product, claims or other accidents, etc.
(F) continuously engaged in the business of medical device imports for not less than 6 years, and can provide the appropriate documents;
(VII) in the last 2 years, the annual import batches of not less than 30 batches;
(VIII) collection and preservation of national standards for medical devices, industry standards and medical device regulations and special provisions, the establishment and preservation of a more complete file of imported medical equipment information, retention period of not less than 10 years;
(IX) with its imports of medical equipment products compatible with the technical training and After-sales service capabilities, or agreed by the third party to provide technical support;
(j) with the scope and scale of imported medical equipment products appropriate, relatively independent of the business premises and storage conditions. Article II import unit shall have the following conditions:
(a) strict compliance with the Commodity Inspection Law and its implementing regulations, other relevant state laws and regulations, as well as the relevant provisions of the State Administration of Quality Supervision, Inspection and Quarantine, with a high degree of integrity, for three consecutive years without adverse records;
(b) have a sound quality management system with a sound quality management system, including import inspection, import inspection, warehousing and storage, quality tracking and defect reporting and so on. Storage, quality tracking and defect reporting system;
(C) has more than one inspection and quarantine institutions trained and qualified quality management personnel, familiar with the basic technology, performance and structure of the relevant products, understanding of China's supervision and management of the inspection of imported medical devices;
(D) agent or business implementation of the mandatory product certification system of imported medical equipment products, should be Obtain the appropriate documents;
(E) agent or business of imported medical equipment product quality reputation, 1 year did not occur due to product quality responsibility for returns, claims or other accidents, etc.;
(F) continuously engaged in the business of importing medical equipment for not less than 3 years, and can provide the appropriate documents;
(VII) in the last 2 years, the annual imports of Batches of not less than 10 batches;
(viii) the collection and preservation of national standards for medical devices, industry standards and medical devices, rules and regulations and special provisions, the establishment and preservation of a more complete file of imported medical equipment information, retention period of not less than 10 years;
(ix) with its imports of medical equipment products and after-sales service capacity to adapt to the technical training and, or to agree to By the third party to provide technical support;
(J) with the import of medical equipment products with the scope and scale of the appropriate, relatively independent business premises. Article 7 three types of imported units include:
(a) engaged in the import of medical devices imported less than three years of business units;
(b) engaged in the import of medical devices imported more than three years of business, but did not file an application for classification and management of imported units;
(c) filed a classification application, after the assessment of the import of units do not meet the conditions of the first two categories, not included in the first two categories of classification and management of the imported units. Import units.