1、医疗器械生产企业质量体系考核办法（局令第 22 号）Methods for the Quality System Inspection onMedical Device Manufacturing Enterprises（SFDA No.22）医疗器械生产企业质量体系考核办法于 2000 年 4 月 29 日经国家药品监督管理局局务会审议通过，现予发布，自 2000 年 7 月 1 日起施行。The Methods for Quality System Inspection on Medical Device Manufacturing Enterprises were created and
2、 passed by the State Food and Drug Administration at the general affairs meeting on April 29, 2000. It is henceforth passed and shall come into force effect from July 1, 2000.二年五月二十二日May 22, 2000医疗器械生产企业质量体系考核办法Methods for Quality System Inspection onMedical Device Manufacturing Enterprise第一条 为加强医疗器
3、械管理，强化企业质量控制，保证病患者的人身安全，根据医疗器械监督管理条例，制定本办法。Article 1These Methods are hereby formulated with a view to strengthening enterprise quality control and administration of Medical Device, ensuring patient safety, and enforcing the Regulations for the Supervision and Administration of Medical Device.第二条 本办
4、法适用于申请第二类、第三类医疗器械准产注册企业的审查及对企业的定期审查。Article 2 These methods are applicable for the inspection of enterprises that apply for Class II and Class III Medical Device manufacturing registration and regular inspections on respective enterprises.下列情况可视同已通过企业质量体系考核：Enterprises meeting the following conditio
5、ns are considered as having already passed the quality system inspection on the enterprise: (一)企业获得国务院药品监督管理部门认可的质量认证机构颁发的 GB/T19001 和 YY/T0287（或 GB/T19002和 YY/T0288）标准的质量体系认证证书，证书在有效期内的。1. The enterprise obtains the quality system certificate GB/ T19001 and YY/T0287 (or GB/T19002 and YY/T0288) issu
6、ed by a quality inspection institution authorized by the State Food and Drug Administration and the certificate is still in its validity period. (二)已实施工业产品生产许可证的产品,其证书在有效期内的。2. The manufacturing license required for the product is within its validity period. (三)已实施产品安全认证，企业持有的产品安全认证证书在有效期内的。3. Produ
7、cts are certified for their safety, with the safety certificates remaining within their validity period第三条 申请第二、三类医疗器械生产企业质量体系考核，均由所在地省、自治区、直辖市药品监督管理部门受理并组织考核。Article 3 The inspection on the quality system of enterprises applying for the production of Class II or Class III Medical Device shall be co
8、llected, organized, and inspected by the respective FDA of the province, autonomous region, or municipality directly under the central government in which the enterprise is located.国家规定的部分三类医疗器械，由所在地省、自治区、直辖市药品监督管理部门受理后，报国家药品监督管理局，由国家药品监督管理局组织考核。Certain Class III medical devices specified by the gov
9、ernment shall be forwarded to and inspected by the State Food and Drug Administration after their applications are handled by the respective FDA of the province, autonomous region, or municipality directly under the central government in which the enterprise is located.部分三类医疗器械目录由国家药品监督管理局确定并公布。The
10、list of specified Class III Medical Device shall be confirmed and distributed by the State Food and Drug Administration.质量体系的考核，可委托下一级药品监督管理部门或具有相应资格的第三方机构进行。质量体系考核结果由委托方负责。The quality system inspection may be entrusted to the next lower-rank FDA or a third party institution with the same qualificat
11、ion. The entrusting party is responsible for the result of the quality system inspection.第四条 企业在申请产品准产注册前，应填写医疗器械生产企业质量体系考核申请书（见附件 1），向省级以上药品监督管理部门提出企业质量体系考核申请。Article 4 Enterprises shall, before applying for the Permission on the Product Registration, fill out the Application Form for the Quality S
12、ystem Inspection of Medical Device Enterprise (see Attachment 1), which is then submitted to the FDA at or above the provincial level.国家规定的部分三类医疗器械的质量体系考核，企业提出质量体系考核申请的同时，向国家药品监督管理局提交被考核产品的质量保证手册和程序文件。For the quality system inspection application of certain Class III Medical Devices specified by the
13、 State, the enterprises shall in addition submit to the SFDA the Quality Assurance Manual and the Procedural Documents for each product under the inspection.其它产品的质量体系考核，企业提出质量体系考核申请前，应按质量体系考核企业自查表（见附件 1 的附表）进行自查，填写自查表。自查表填写内容应如实、准确，以备现场考核时查验。Before submitting the quality system inspection applicatio
14、n for all other products, enterprises shall fill in the Self- Inspection Form on the Quality System Inspection of the Enterprise (see the form in Attachment 1) and perform self-inspection accordingly. The content of the self-inspection form shall be authentic and accurate for the time the inspection
15、 is performed.第五条 对二类医疗器械，省、自治区、直辖市药品监督管理部门应对企业填写的质量体系考核企业自查表和提供的相关资料进行审核，经审核后签署意见，必要时可对申请企业进行现场查验。Article 5 For Class II Medical Device, the respective FDA of the province, autonomous region, and municipality directly under the central government shall check the Self-Inspection Form and any relativ
16、e materials submitted by the enterprise and note their decision; the FDA concerned shall, where necessary, perform an on-site inspection to check the validity of materials submitted.对三类医疗器械，按本办法第三条执行后，质量体系考核申请和考核报告（见附件 1,2）应在国家药品监督管理局备案正本（原件）一份。For Class III Medical Device, following the execution o
17、f Article 3 of these methods, one original copy of both the Quality Examination System Application Form and the inspection report (see Attachment 1 and 2) shall be filed and recorded for reference with the State Food and Drug Administration.第六条 考核人员至少应有一人经贯彻 GB/T19001 和 YY/T0287 标准的培训，并取得内审员或外审员的资格；
18、考核人员至少由二人组成；确定的考核人员与被考核的企业应无经济利益联系。Article 6 At least one auditor shall be trained on the GB/T19001 and YY/T0287 standards and shall be qualified as an internal auditor or external auditor; the inspection group shall be comprised of at least two persons; the appointed auditor shall have no economic
19、relation to the enterprise under inspection.第七条 质量体系现场考核，参照质量体系认证审核的方法；依据附件 1 自查表确定的内容进行考核，重点考核项目及判定规则为：Article 7 The on-site quality inspection shall follow the methods for the quality system certification; the inspection shall be carried out in accordance with the contents of Attachment 1 self-ins
20、pection chart, the focus items shall be based on the following determining criterion:产品类别Product Classification重点考核项目Focus Assessment Items考核结论Assessment ResultClass III 4. 1, 2 1. 重点考核项目全部合格，其它考核项目不符合项不超过五项，判定为通过考核。Focus assessment items all passed, with not more than five items failed in other ass
21、essments, shall be considered as pass. 2. 重点考核项目有不合格，其它考核项目不符合项超过五项，判定为整改后复核。One or more focus assessment items fail, with not more than five items failed in other assessments, shall be re-assessed following the correction.5. 1, 3 6. 1, 2, 3 7 . 1, 2, 3, 9, 10 8. 1, 2, 6, 7, 8 9. 2, 3, 4, 5 Class II
22、 4. 1 1. 重点考核项目全部合格，其它考核项目不符合项不超过五项，判定为通过考核。Focus assessment items all passed, with not more than five items failed in other assessments, shall be considered as pass. 2. 重点考核项目有不合格，其它考核项目不符合项超过五项，判定为整改后复核。Failure in one or more focus assessment items, with not more than five items failed in other as
23、sessments, shall be re-assessed following the correction.5. 1, 3 6. 1 7. 1, 2 8. 1, 6, 8 9. 2, 3, 4 考核结论判定为“通过考核”的，对质量体系的评价和存在不合格项要如实陈述，对不合格项给出整改期限。不能如期完成整改的应作为“整改后复核”处理。Enterprises receiving a “pass” assessment result shall make an authentic statement on the inspection of the quality system and the
24、 existing “failed” items, and shall denote the deadline for the correction of the “failed” items. Enterprises failing to complete the correction as of the deadline stated shall be dealt with as “re-inspect following correction”.第八条 考核结论为“整改后复核”的，以“考核报告”的签署日起，企业必须在半年内完成整改并申请复核，逾期将取消申请准产注册资格。Article 8
25、 Enterprises decided as “re-inspect following correction” shall complete the correction and re-apply for inspection within six months since the sign-off date of the “inspection report”, otherwise the qualification for the registration application shall be revoked.第九条 企业产品质量体系考核以“考核报告”通过的签署日为准，其有效期为四
26、年；在有效期内企业申请同类产品准产注册，不再进行考核（药品监督管理部门另有规定的除外）。Article 9 The validity period of the quality system inspection of the enterprise is four years from the sign-off date of passing; during the validity period, enterprises applying for the permission registration of the same class products are not to be insp
27、ected again (unless otherwise specified by the regulations of the Food and Drug Administration).企业应定期进行质量体系自查，自查结果应按质量体系考核企业自查表的规定进行记录、归档。Enterprises shall carry out self-inspection on its quality system at regular intervals and the assessment result shall be documented and maintained according to t
28、he requirements set forth in the Self-inspection form of the quality system of the enterprise.省、自治区、直辖市药品监督管理部门定期对企业进行体系审查。The respective FDA of each province, autonomous region, and municipality directly under the central government shall perform scheduled inspection on enterprises.第十条 企业通过质量体系考核后，
29、不按规定进行自查、不按质量体系要求组织生产的，经核实，由所在地省、自治区、直辖市药品监督管理部门予以警告，并限期整改。Article 10 Enterprises not performing scheduled self-inspections or manufacturing according to the quality system requirements after passing the quality examination, shall be issued a corrective warning by the food and drug administration de
30、partment of the respective province, autonomous region, and municipality directly under the central government and with the duration for the corrective actions specified.第十一条 本办法由国家药品监督管理局负责解释。Article 11 The State Food and Drug Administration shall be responsible for the further clarification of any
31、 part of these methods.第十二条 本办法自 2000 年 7 月 1 日起施行。Article 12 These methods shall come into force on April 20, 2000 . 附件 1Attachment 1 医疗器械生产企业质量体系考核申请书Application Form for the Quality System Inspection on Medical Device Enterprises本企业根据医疗器械监督管理条例中医疗器械注册管理办法要求，准备办理： 产品准产注册；现已按医疗器械生产企业质量体系考核办法做了准备，进行
32、了质量体系自查，并保证填报内容真实，现申请质量体系考核。This enterprise, on the basis of the requirements set forth in the Regulations for the Supervision and Administration of Medical Devices, intends to conduct registration for the manufacturing of_ product. It has completed preparations based on the Methods for Quality Syst
33、em Inspection on Medical Device Manufacturing Enterprises, has completed the quality self-inspection and assures the authenticity of content contained in the form, and hereby applies for the quality.附质量体系考核企业自查表一份。Enclosed is one copy of the Self-Inspection Form for the Quality System Inspection of
34、the Enterprise.（企业名称，法人代表签字）_._._._年_月_日（企业盖章）Name of the Enterprise, Signature of Legal Representative_. _. Year Month Day (Enterprise Seal)质量体系考核企业自查表Self-Inspection Form for the Quality System Inspection of the Enterprise一、企业基本情况 Basic Information of the Enterprise企业名称Enterprise Name经济性质Economic
35、Classification隶属关系Affiliations地 址 Address邮 编 Postal Code电 话Telephone传 真Fax法人代表Legal Representative职 务Title职 称Professional Rank联 系 人Contact Person职 务 Title 职 称Professional Rank企 业 管 理 人 员 一 览 表 List of the Enterprise Management Personnel 姓名 Name 性别Gender年龄 Age 文化程度Highest Education Completed职务 Title
36、职称Professional Rank主管工作 Primary Job主要产品 种类：Main Product Varieties:建厂日期 ：Date of Establishment:占地面积 平方米 Square Meters 建筑 面积 Construction 平方米 Square MetersLand Area Covered职工总数Number of Employees in total人 人注册资金Registered Capital万元 In Millions - RMB 万元 In Millions - RMB上年医械总产值 Gross Product of Medical
37、 Device of Previous Year万元 In Millions - RMBArea中级职称 以上人数 Total Number of Employees w/ Intermediate Rank or Above固定资产 原值Value of Fixed Capital上年医械 销售收入Sales of Medical Device of the Previous Year万元 In Millions - RMB质量情况Quality Condition(有无出口，国家质量抽查情况，试产期用户反映)(With or without export, result of the qu
38、ality sample check performed by the state, user feedback during the pilot production)二、按照 GB/T19000 系列标准建立健全企业质量体系计划II. Establish a comprehensive plan for the quality system according to the GB/T19000 standard series.1.是否准备按 GB/T19001（或 GB/T19002）；YY/T0287（或 YY/T0288）标准建立健全本企业质量体系？ 是 否1. Is the ente
39、rprise about to establish and complete its quality system based on the GB/T19001 (or GB/T19002), and YY/T0287 (or YY/T0288) standards series? Yes No 2.企业打算在_年申请质量体系认证。或尚无计划。2. The enterprise plans to apply for the quality system certificate in year _. Or the plan is yet to be made.3.企业有_人接受了 GB/T190
40、00 系列标准及 YY/T0288 标准的培训。取得内审员证书的有_ 人。3. _persons have been trained on GB/T19000 and YY/T0288 series standards. _ persons are qualified as internal auditors. 4.企业通过质量体系认证的困难是：4. The challenge(s) for passing the quality system inspection and certification for the enterprise are the following:费用问题 ； 无人
41、指导 ； 管理水平低 ；Expense ; Lacking Guidance ; Low Management Level认识不够 ； 迫切性不大 Lack of Familiarity; Low urgency level三、本次申请注册产品名称和报告适用范围III. The Name of the Product under the Registration and the Scope of Application.申请注册产品名称：_。Names of products for the registration certificate _.本报告覆盖产品范围及名称：_ 。Range an
42、d name of the products covered by the report: _.四、企业质量管理职责IV. Quality Management Responsibility of the Enterprise1.与质量有关的管理、执行、验证工作人员是否规定了质量职责并形成文件。 有无1. Are the quality responsibilities defined and documented for personnel performing quality related activities such as management, execution and vali
43、dation? Yes No 2.企业的管理者代表是_ 。或未指定 2. The management representative of the enterprise is _. Or has not been appointed 3.能否提供企业质量体系组织结构图。 能否3. Can the organization chart of the quality system be provided or not? Yes No 4.企业是否收集并保存与生产、经营有关的法律、法规、行政规章，各级质量标准。 是 否4. Does the enterprise collect and mainta
44、in the laws, statutes, administration regulations and quality standards of various levels related to its production and business operation? Yes No 5.企业法人代表或管理者代表是否经过了 GB/T19000 及 YY/T0287 标准的培训。 是否5. Has the enterprise legal representative(s) or administrative representative(s) been trained on the G
45、B/T19000 and YY/T0287 series standards? Yes No五、设计控制 V. Design Control 1.企业是否建立并保持设计控制和验证的形成文件的程序或相应要求。 是否1. Has the enterprise established and maintained the documented procedures or requirements for the design control and validation? Yes No 2.在设计过程中是否进行了风险分析 是 否2. Has a risk analysis been carried
46、out during the design process? Yes No 3.是否建立并保存了该产品的全部技术规范和应用的技术文件（包括产品技术文件清单） 是 否3. Are the technical documents set up and maintained of all technical specifications and their applications (including the list of product technical documents)? Yes No 4.是否保存了试产注册后该产品设计修改的记录。 是否 4. Are the records main
47、tained of the design modifications after the pilot production? Yes No六、采购控制VI. Purchase Control 1.是否建立并保持控制采购过程的形成文件的程序。 是 否1. Are the documented purchase control procedures established and maintained? Yes No 2. 是否建立了申请准产注册产品主要采购内容清单，并确定了合格分承包方。 是 否2. Is the main purchase list of the products under
48、the application established with the qualified contractors defined? Yes No 3.该产品的采购资料是否清楚、明确、齐全。 是 否3. Is the purchase data of the product clear, definite, and complete? Yes No七、过程控制VII. Process control1.是否确定了申请准产注册产品的关键过程和特殊过程（工序）并制定了相应的控制文件或作业指导书。是 否1. Are both the key and special processes confirmed for the product under the application and are the corresponding control documents and work instructions formulated? Yes No2.无菌医疗器械是否按照无菌医疗器械生产管理规范组织生产。 是否2 Are sterile medical devices manufactured as per the Good Manufacturing Practice for Sterile Medical Devices?
