Hello, now the latest version is September 2011.
(a) This standard is based on the "Medical Device Business License Management" (State Food and Drug Administration Decree No. 15) to develop and "Hunan Province, the supervision and management of the circulation of medicines and medical devices regulations", and reported to the State Food and Drug Administration and the Hunan Provincial People's Government Legislative Affairs Office for the record.
(b) This standard applies to medical device business enterprises in Hunan Province (retail) qualification recognition of on-site inspection and acceptance, including applications for licenses, applications for reissuance of licenses, as well as changes in licensing matters; but also medical device business enterprises to conduct self-inspection and food and drug supervision and management at all levels of the daily supervision and inspection of medical device business enterprises on the basis of.
(C) this standard *** 3 major 20 articles, of which the veto 8, general 12.
Part I: personnel and institutions, Item No. 1.1 to 1.7;
Part II: site and facilities, Item No. 2.1 to 2.5;
Part III: systems and records, Item No. 3.1 to 3.8;
(d) Application for the issuance and replacement of the "Medical Device Business License," the daily supervision and must be inspected All contents. Change the person in charge of quality; check the qualifications of its quality personnel; change of business address, warehouse address check the second part of the site and facilities; change the scope of business is checked in its entirety.
(E) the criteria for determining: on-site inspection, should be listed in the project and its coverage of the content of a comprehensive inspection, and make a conformity or non-conformity assessment. Negative items and general items all qualified, judged to pass the on-site inspection; Negative items qualified, but any general items failed, judged to fail the on-site inspection, given a deadline for rectification, the enterprise submitted rectification report and application for re-inspection of the report, by the Provincial Bureau of the re-organization of the on-site inspection; any negative items failed, judged to be unqualified, the information retired from the review, the enterprise 6 months before the declaration of the re-declaration.
(F) the approved scope of business will be based on the application of the enterprise, on-site inspection of the final conclusion of the comprehensive approval. Retail enterprises are limited to: (a) Class II: 6815 glass syringes; 6823 ultrasonic nebulizer; 6824 weak laser external therapeutic device (home); 6826 physical therapy and rehabilitation equipment; 6827 Chinese medicine apparatus; 6840 test strips; 6846 hearing aids (except implantable): 6854 medical gas equipment (home); 6866 medical high molecular weight material and products. Class Ⅲ: 6815 single-use sterile syringes, single-use sterile injecting needles; 6822 corneal contact lenses and care solution; 6826 high-voltage potentiostatic therapy apparatus (household). Enterprises can independently operate Class I medical devices and some Class II medical devices that do not require application for a Medical Device Operator's License (subject to the product list established by the state). (B) only directly to the consumer's personal sales of medical equipment is the nature of the fitting of the enterprise business scope is approved for corneal contact lenses and care solution, or hearing aids (except implantable hearing aids).
(H) State Food and Drug Administration has new provisions, from its provisions.
(VII) the meaning of some of the terms used in this standard:
(1) medical device retail: the purchase of medical devices will be sold directly to consumers of medical equipment business enterprises.
(2) medical device-related professions, refers to machinery, engineering, chemistry, medical imaging, nursing, computer science, clinical medicine, pharmacy, laboratory science, information automation and other professions.
(3) The first enterprise: it refers to the medical equipment manufacturing and operating enterprises whose supply and demand relationship occurs for the first time in this enterprise.
(4) the first varieties: refers to the enterprise to a medical device manufacturer or business enterprise for the first time to purchase medical equipment varieties.