医疗器械生产企业质量体系考核办法22号令

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 on Medical 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 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ＯＯＯ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 on Medical Device Manufacturing Enterprise

第一条 为加强医疗器械管理，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 conditions 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) issued 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. Products 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 collected, 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 government 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 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 qualification. 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 System 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 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 application 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 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 relative 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 of 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；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 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-inspection chart, the focus items shall be based on the following determining criterion:

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 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 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 inspected 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 the 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，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 department 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 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1] Attachment 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，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 System 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 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

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 enterprise 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/T19000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 and name of the products covered by the report: _____________________________. 四、企业质量管理职责

IV. Quality Management Responsibility of the Enterprise

1. 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 validation? 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 maintain 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 GB/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 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 maintained 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 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 control

1. 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 No

2. 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? Yes No

3. 该产品所需的设备、工装、检验仪表是否具备，并能满足产品制造过程的要求。 是□ 否□

3. Are the equipment, tooling, testing instruments and gauges in place for the product and are they capable of meeting the requirements of the manufacturing process? Yes No

4. 参加该产品的施工制造人员是否具备相应资格或经过针对性的培训。 是□否□

4. Personnel involved in the product formation and in the production possess the adequate qualifications or have received job-specific trainings. Yes No

5. 是否确定了该产品过程检验的内容、规程和记录。是□ 否□

5. Are the content, procedures, and records of the inspection process confirmed? Yes No

6. 是否对该产品要求的作业环境，产品清洁作出规定。是□否□

6 Are the requirements in place for the work environment and product cleaning? Yes No

7. 是否建立了用于该产品安装、查验的技术资料和接受准则。是□ 否□

7 Are the technical data and acceptance criteria set up for product installation and inspection?

8. 是否规定了过程控制中应形成的记录。 是□ 否□

8 Are documentation requirements set up for the process control? Yes No

9. 是否对该产品的可追溯性范围和程度进行了确定。（材料、元件、过程和去向）。是□ 否□

9. Are the scope and extent defined for product traceability? (Including materials, components, process, and destination)Yes No

10、现场能否看到产品标识（包括最终产品的标签）及检验试验状态的标识。 是□ 否□

10. Are the product labeling (including the final product labels) and the labeling of inspection and test status

visible on site? Yes No

八、产品检验和试验

VIII. Product Inspection and Testing

1. 是否设有专职的检验试验机构，并规定了其职责和权限。对有源医疗器械和植入性医疗器械是否记录了检验人员身份。是□ 否□

1. Are the professional inspection and test institution established with the corresponding responsibilities and authorities defined? Is the identification of the inspection personnel documented for active medical devices and the implant-able medical devices? Yes No

2. 是否建立了进行检验和试验，形成文件的程序。 是□否□

2. Are documented procedures established for inspection and tests? Yes No

3. 是否进行进货检验和验证。 是□ 否□

3. Are the inspection and verification performed on the incoming stock? Yes No

列出进货检验和验证规程、名称______________________________ ___________________________________________________。

List the procedures and their titles for the inspection and verification of the incoming stock __________________________________________________________________ ___________.

4. 是否进行过程检验。 是□ 否□

4. Is in-process inspection carried out? Yes No

列出过程检验的检验规程、名称______________________________

_____________________________________________________。

List the procedures and their titles for the in-process inspection

_____________________________________________________________________________.

5. 最终产品的检验试验是否覆盖了该产品的技术标准全部出厂检验项目。 是□ 否□

5. The test and inspection on final products cover all the inspection items of ex-works technical specifications. Yes No

6. 上述检验试验记录及最近一次型式试验报告是否保存。是□ 否□

6. Are the test and inspection records maintained with the latest comprehensive test report in place? Yes No

7. 企业有无相应的测试设备。 是□ 否□

7. Does the enterprise possess adequate testing equipment? Yes No

8. 企业是否建立并实施了对检验、测量和试验设备进行控制、校准和维护的规定文件。 是□ 否□

8. Has the enterprise established and implemented the documented procedures for the control, calibration, and maintenance of the inspection, measurement and testing equipment? Yes No

九、其它方面IX. Other Aspects

1. 企业是否定期对产品质量及质量管理工作进行审核，评审和评价。 是□ 否□

1. Has the enterprise regularly carried out the audit, evaluation, and assessment on product quality and quality management activities? Yes No

2. 是否保留了前款评价活动的记录。 是□ 否□

2. Are records maintained of the previous evaluation activities? Yes No

3. 是否对不合格品如何评价处理作出规定。 是□ 否□

3. Is there any requirement in place on the handling of non-conformance? Yes No

4. 是否按一定程序处理顾客投诉并保留记录。 是□ 否□

4. Are customer complaints handled as per procedures with records maintained? Yes No

5. 有无实施纠正和预防措施的规定文件。 是□ 否□

5. Are procedures in place for the implementation of corrective and preventive measures? Yes No

十、省级主管部门对企业自查结果的审核意见：

X. Decision on the self-inspection results by the Provincial administration department:

年 月 日 （主管部门盖章）

Year Month Day (Departmental Director's Seal)

附件2 Attachment 2

医疗器械生产企业质量体系考核报告

Quality System Inspection Report for Medical Device Manufacturing Enterprises

一、考核组成员

I. Inspection Team Members

二、被考核方主要现场人员

II. Members of Inspected Unit Present

三、考核日期：__________________ III. Inspection date: _____________

四、考核结论和建议

IV. Inspection results and suggestions:

1）对企业质量体系的基本评价。1. Basic evaluation on the quality system of the enterprise.

2）对主要不合格内容的陈述。2. Statement on non-conforming sections.

3）考核结论（建议通过考核，建议整改后复核）。3. Conclusion (Inspection passed, or re-inspection following adjustment and correction suggested).

4）考核组长签字 日期

4. Head Inspector signature ____________ Date____________

五、企业法人代表意见

V. Remarks from the Enterprise Legal Representative

企业法人代表签字 ________日期________

Signature of the Enterprise Legal Representative_______________ Date___________