CFDA Announcement on Releasing Good Manufacturing Practice for Medical Devices ([2014] No. 64)

國家食品藥品監督管理總局關于發布醫療器械生產質量管理規范的公告（2014年第64號）
CFDA Announcement on Releasing Good Manufacturing Practice for Medical Devices ([2014] No. 64)


關于發布醫療器械生產質量管理規范的公告
Announcement on Releasing Good Manufacturing Practice for Medical Devices

為加強醫療器械生產監督管理，規范醫療器械生產質量管理，根據《醫療器械監督管理條例》（國務院令第650號）、《醫療器械生產監督管理辦法》（國家食品藥品監督管理總局令第7號），國家食品藥品監督管理總局組織修訂了《醫療器械生產質量管理規范》，現予以發布。
In order to enhance the supervision and administration of, and standardize the quality management of, the medical devices manufacturing, and in accordance with the Regulations for the Supervision and Administration of Medical Devices ( State Council Order No. 650) and the Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7), China Food and Drug Administration(“CFDA”) organized the revision of the Good Manufacturing Practice for Medical Devices, and which is hereby released.

特此公告。
It is hereby notified!

附件：醫療器械生產質量管理規范
Annex: Good Manufacturing Practice for Medical Devices

食品藥品監管總局
China Food and Drug Administration

2014年12月29日
December 29, 2014

附件
Annex

醫療器械生產質量管理規范
Good Manufacturing Practice for Medical Devices

第一章 總 則
Chapter I General Provisions

第一條 為保障醫療器械安全、有效，規范醫療器械生產質量管理，根據《醫療器械監督管理條例》（國務院令第650號）、《醫療器械生產監督管理辦法》（國家食品藥品監督管理總局令第7號），制定本規范。
Article 1 With a view to ensuring the safety and effectiveness of medical devices and standardizing the management on quality of medical devices manufacturing, the Good Manufacturing Practice for Medical Devices (“GMP”) is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices (State Council Order No.650) and the Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7).

第二條 醫療器械生產企業（以下簡稱企業）在醫療器械設計開發、生產、銷售和售后服務等過程中應當遵守本規范的要求。
Article 2 Medical device manufacturers (hereinafter referred to as “manufacturers”) shall comply with the requirements set out in the GMP when designing and developing,manufacturing and selling medical devices, as well as providing after-sales service.

第三條 企業應當按照本規范的要求，結合產品特點，建立健全與所生產醫療器械相適應的質量管理體系，并保證其有效運行。
Article 3 Manufacturers shall establish and improve the quality management system adapted to the medical devices manufactured in combination with product features according to the requirements in the GMP and ensure its effective operation.

第四條 企業應當將風險管理貫穿于設計開發、生產、銷售和售后服務等全過程，所采取的措施應當與產品存在的風險相適應。
Article 4 Manufacturers shall conduct risk management through the whole process of design and development,manufacture, sales and after-sales service and take the measures adapted to product risks.

第二章 機構與人員
Chapter II Institution and Personnel

第五條 企業應當建立與醫療器械生產相適應的管理機構，并有組織機構圖，明確各部門的職責和權限，明確質量管理職能。生產管理部門和質量管理部門負責人不得互相兼任。
Article 5 Manufacturers shall establish the regulatory agency adapted to medical device manufacture with the organizational chart which clarifying the responsibilities and authorities of all divisions as well as quality function &responsibilities. Neither the head of manufacture management department nor the head of quality management department shall hold a concurrent post with each other.

第六條 企業負責人是醫療器械產品質量的主要責任人，應當履行以下職責：
Article 6 The principal of manufacturers is the main responsible person of the quality of medical devices and shall fulfill the following responsibilities:

（一）組織制定企業的質量方針和質量目標；
(1) Organize the formulation of quality policy and quality objectives of manufacturers;

（二）確保質量管理體系有效運行所需的人力資源、基礎設施和工作環境等；
(2) Ensure the human resources, infrastructures and working environment required for the effective operation of quality management system, etc.;

（三）組織實施管理評審，定期對質量管理體系運行情況進行評估，并持續改進；
(3) Organize the management review and carry out periodical evaluation on the operation of quality management system, and continuously improve it;

（四）按照法律、法規和規章的要求組織生產。
(4) Organize themanufacture in accordance with laws and regulations.

第七條 企業負責人應當確定一名管理者代表。管理者代表負責建立、實施并保持質量管理體系，報告質量管理體系的運行情況和改進需求，提高員工滿足法規、規章和顧客要求的意識。
Article 7 The principal of the manufacturer shall appoint a management representative. Such management representative shall be responsible for establishing, implementing and maintaining the quality management system, report the working conditions and improvement needs of the quality management system, and enhance the employees’ awareness of complying with the regulations, rules and customer requirements.

第八條 技術、生產和質量管理部門的負責人應當熟悉醫療器械相關法律法規，具有質量管理的實踐經驗，有能力對生產管理和質量管理中的實際問題作出正確的判斷和處理。
Article 8 The head of technical, manufacture and quality management department shall be familiar with laws and regulations related to medical devices, have practical experiences on quality management and be able to make correct judgment and handling for the practical problems in manufacture management and quality management.

第九條 企業應當配備與生產產品相適應的專業技術人員、管理人員和操作人員，具有相應的質量檢驗機構或者專職檢驗人員。
Article 9 Manufacturers shall be equipped with the professional and technical personnel, management and operating personnel adapted to the products manufactured and have corresponding quality testing institutions or full-time testing personnel.

第十條 從事影響產品質量工作的人員，應當經過與其崗位要求相適應的培訓，具有相關理論知識和實際操作技能。
Article 10 The personnel engaged in the work affecting the product quality shall receive the training adapted to their job requirements and have relevant theoretical knowledge and practical operation skills.

第十一條 從事影響產品質量工作的人員，企業應當對其健康進行管理，并建立健康檔案。
Article 11 Manufacturers shall manage the health of the personnel engaged in the work affecting the product quality and establish health records.

第三章 廠房與設施
Chapter III Buildings and Facilities

第十二條 廠房與設施應當符合生產要求，生產、行政和輔助區的總體布局應當合理，不得互相妨礙。
Article 12 Buildings and facilities shall conform to manufacturing requirements. The overall lay out of manufacture, administration and the auxiliary areas shall be rational without interference with each other.

第十三條 廠房與設施應當根據所生產產品的特性、工藝流程及相應的潔凈級別要求合理設計、布局和使用。生產環境應當整潔、符合產品質量需要及相關技術標準的要求。產品有特殊要求的，應當確保廠房的外部環境不能對產品質量產生影響，必要時應當進行驗證。
Article 13 Buildings and facilities shall be rationally designed, deployed and applied according to the features, technological process and corresponding air cleanness class of the products manufactured. The manufacturing environment shall be clean and tidy and comply with the need of product quality and requirements in relevant technical standards. Where products have special requirements, it shall be ensure that the external environment of the buildings has no effect on products, and carry out verification if necessary.

第十四條 廠房應當確保生產和貯存產品質量以及相關設備性能不會直接或者間接受到影響，廠房應當有適當的照明、溫度、濕度和通風控制條件。
Article 14 It shall ensure the quality of the products manufactured and stored and properties of relevant equipment not directly or indirectly influenced in the buildings,which shall be equipped with appropriate illumination, temperature, humidity and ventilating control conditions.

第十五條 廠房與設施的設計和安裝應當根據產品特性采取必要的措施，有效防止昆蟲或者其他動物進入。對廠房與設施的維護和維修不得影響產品質量。
Article 15 For the design and installation of buildings and facilities, necessary measures shall be taken in accordance with the product features so as to effectively prevent the insects or other animals from entering. The maintenance and repair of buildings and facilities shall not affect the product quality.

第十六條 生產區應當有足夠的空間，并與其產品生產規模、品種相適應。
Article 16 There shall be sufficient space in the production area, matching with the manufacturing scale and type of the products to be manufactured there.

第十七條 倉儲區應當能夠滿足原材料、包裝材料、中間品、產品等的貯存條件和要求，按照待驗、合格、不合格、退貨或者召回等情形進行分區存放，便于檢查和監控。
Article 17 The warehousing area shall meet the storage conditions and requirements necessary for the raw materials, packaging materials, intermediate products and finished products, within which they shall be stored in different segments as per their following status, namely, products to be inspected, conforming, nonconforming,returned or recalled, so as to facilitate the inspection and monitoring.

第十八條 企業應當配備與產品生產規模、品種、檢驗要求相適應的檢驗場所和設施。
Article 18 Manufacturers shall be equipped with inspection place and facilities adapted to the manufacturing scale, varieties and inspection requirements of products.

第四章 設 備
Chapter IV Equipment

第十九條 企業應當配備與所生產產品和規模相匹配的生產設備、工藝裝備等，并確保有效運行。
Article 19 Manufacturers shall be equipped with manufacturing equipment and technological equipment matched with the products manufactured and manufacturing scale, and ensure their effective operation.

第二十條 生產設備的設計、選型、安裝、維修和維護必須符合預定用途，便于操作、清潔和維護。生產設備應當有明顯的狀態標識，防止非預期使用。
Article 20 Manufacturing equipment shall conform to intended use in terms of design, model selection, installation, repair and maintenance to facilitate the operation,cleaning and maintenance. Manufacturing equipment shall have obvious status identification to prevent non-intended use.

企業應當建立生產設備使用、清潔、維護和維修的操作規程，并保存相應的操作記錄。
Manufacturers shall establish the operating procedures for the use, cleaning,maintenance and repair of manufacturing equipment and maintain corresponding operating records.

第二十一條 企業應當配備與產品檢驗要求相適應的檢驗儀器和設備，主要檢驗儀器和設備應當具有明確的操作規程。
Article 21 Manufacturers shall be equipped with related inspection instruments and equipment according to the product inspection requirements. There shall be clear operating procedures for main inspection instruments and equipment.

第二十二條 企業應當建立檢驗儀器和設備的使用記錄，記錄內容包括使用、校準、維護和維修等情況。
Article 22 Manufacturers shall establish usage records of inspection instruments and equipment, including the usage, calibration, maintenance and repair, etc.

第二十三條 企業應當配備適當的計量器具。計量器具的量程和精度應當滿足使用要求，標明其校準有效期，并保存相應記錄。
Article 23 Manufacturers shall be equipped with appropriate measuring instruments, of which the measuring range and precision shall meet operating requirements, the expiration date of calibration indicated, and the corresponding records maintained.

第五章 文件管理
Chapter V Document Management

第二十四條 企業應當建立健全質量管理體系文件，包括質量方針和質量目標、質量手冊、程序文件、技術文件和記錄,以及法規要求的其他文件。
Article 24 The manufacturer shall establish and perfect the quality management system documents, including the quality policies and quality objectives, the quality manual, the procedure files, the technical documents and records, and other documents required by regulations.

質量手冊應當對質量管理體系作出規定。
Quality manual shall include the requirements for quality management system.

程序文件應當根據產品生產和質量管理過程中需要建立的各種工作程序而制定，包含本規范所規定的各項程序。
Procedure files shall be formulated according to all working procedures to be established in product manufacturing and quality management, and shall contain all procedures specified in the GMP.

技術文件應當包括產品技術要求及相關標準、生產工藝規程、作業指導書、檢驗和試驗操作規程、安裝和服務操作規程等相關文件。
Technical documents shall include relevant documents such as product technical specification and relevant standards, manufacturing process procedures, operation instruction,operating procedures for inspection and testing, and operating procedures for installation and service, etc.

第二十五條 企業應當建立文件控制程序，系統地設計、制定、審核、批準和發放質量管理體系文件，至少應當符合以下要求：
Article 25 Manufacturers shall establish the document control procedure, systematically design, develop, review, approve and issue the documents of quality management system, which shall at least conform to the following requirements:

（一）文件的起草、修訂、審核、批準、替換或者撤銷、復制、保管和銷毀等應當按照控制程序管理，并有相應的文件分發、替換或者撤銷、復制和銷毀記錄；
(1) The draft,revision, review, approval, replacement or withdrawal, duplication, storage and destruction of documents shall be managed according to control procedures with corresponding records of document distribution, replacement or withdrawal,duplication and destruction;

（二）文件更新或者修訂時，應當按規定評審和批準，能夠識別文件的更改和修訂狀態；
(2) The update or revision of documents shall be reviewed and approved according to regulations.The modification and revision status of the documents shall be able to be identified;

（三）分發和使用的文件應當為適宜的文本，已撤銷或者作廢的文件應當進行標識，防止誤用。
(3) The documents to be distributed and used shall be the appropriate documents, and those withdrawn or abolished shall be indicated to prevent misuse.

第二十六條 企業應當確定作廢的技術文件等必要的質量管理體系文件的保存期限，以滿足產品維修和產品質量責任追溯等需要。
Article 26 Manufacturers shall validate the storage life of abolished technical documents and other necessary quality management system documents so as to meet the need for product maintenance and traceability of product quality responsibilities.

第二十七條 企業應當建立記錄控制程序，包括記錄的標識、保管、檢索、保存期限和處置要求等，并滿足以下要求：
Article 27 Manufacturers shall establish the record control procedure, including the identification,storage, searching, storage life and disposal requirements, etc. of the records, which shall meet the following requirements:

（一）記錄應當保證產品生產、質量控制等活動的可追溯性；
(1) The records shall ensure the traceability of the activities such as product manufacturing and quality control;

（二）記錄應當清晰、完整，易于識別和檢索，防止破損和丟失；
(2) The records shall be clear, complete, easy to be identified and searched, and prevented from damage and loss;

（三）記錄不得隨意涂改或者銷毀，更改記錄應當簽注姓名和日期，并使原有信息仍清晰可辨，必要時，應當說明更改的理由；
(3) The records shall not be arbitrarily altered or destroyed. It shall endorse one’s name and date for altering the records with original information that shall still be clear,and the reason for the alteration shall be illustrated when necessary;

（四）記錄的保存期限應當至少相當于企業所規定的醫療器械的壽命期，但從放行產品的日期起不少于2年，或者符合相關法規要求，并可追溯。
(4) The storage life of records shall at least be equivalent to the shelf life of medical devices specified by manufacturers, but shall not be less than two years upon releasing date of products or incompliance with relevant laws and regulations, and shall be traceable.

第六章 設計開發
Chapter VI Design and Development

第二十八條 企業應當建立設計控制程序并形成文件，對醫療器械的設計和開發過程實施策劃和控制。
Article 28 The manufacturer shall establish the design control procedures and formulate corresponding documents, and the medical device design and development process may be planned and controlled.

第二十九條 在進行設計和開發策劃時，應當確定設計和開發的階段及對各階段的評審、驗證、確認和設計轉換等活動，應當識別和確定各個部門設計和開發的活動和接口，明確職責和分工。
Article 29 When planning the medical device design and development, the manufacturer shall validate the design and development stages, as well as the review,verification, validation and design conversion in each stage, and identify and validate the design and development activities attributable to each department and the interfaces so as to define their respective duties and functions.

第三十條 設計和開發輸入應當包括預期用途規定的功能、性能和安全要求、法規要求、風險管理控制措施和其他要求。對設計和開發輸入應當進行評審并得到批準，保持相關記錄。
Article 30 The design and development input shall include the function， the performance and the safety requirements, regulatory requirements, risk control measures and other requirements set out in the intended use. The design and development input shall be reviewed and obtain approval, and relevant records shall be maintained.

第三十一條 設計和開發輸出應當滿足輸入要求，包括采購、生產和服務所需的相關信息、產品技術要求等。設計和開發輸出應當得到批準，保持相關記錄。
Article 31 The design and development output shall meet the input requirements, including the information and product technical specification necessary for the product procuring, manufacturing and service. The design and development output shall be approved, and relevant records shall be maintained.

第三十二條 企業應當在設計和開發過程中開展設計和開發到生產的轉換活動，以使設計和開發的輸出在成為最終產品規范前得以驗證，確保設計和開發輸出適用于生產。
Article 32 In the process of design and development, the manufacturer shall perform the manufacturing conversion activities relating to design and development, so as to ensure the design and development output to be verified prior to final product specifications and ensure that the design and development output applicable to the manufacturing.

第三十三條 企業應當在設計和開發的適宜階段安排評審，保持評審結果及任何必要措施的記錄。
Article 33 The manufacturer shall schedule review in suitable design and development stage and maintain the records related to the review results and any necessary measures.

第三十四條 企業應當對設計和開發進行驗證，以確保設計和開發輸出滿足輸入的要求，并保持驗證結果和任何必要措施的記錄。
Article 34 The manufacturer shall verify the design and development to ensure that the output meets the input requirements and maintain the records related to the verification results and any necessary measures.

第三十五條 企業應當對設計和開發進行確認，以確保產品滿足規定的使用要求或者預期用途的要求，并保持確認結果和任何必要措施的記錄。
Article 35 The manufacturer shall validate the design and development to ensure that the products meet the required application requirements or the requirements for intended use and maintain the records related to the validation results and any necessary measures.

第三十六條 確認可采用臨床評價或者性能評價。進行臨床試驗時應當符合醫療器械臨床試驗法規的要求。
Article 36 The manufacturer shall validate whether clinical evaluation or performance evaluation may be applied. Any clinical trial shall be conducted in accordance with the regulations for medical device clinical trials.

第三十七條 企業應當對設計和開發的更改進行識別并保持記錄。必要時，應當對設計和開發更改進行評審、驗證和確認，并在實施前得到批準。
Article 37 The manufacturer shall identify any changes to the design and development and maintain relevant records. When necessary, the manufacturer shall review, verify and validate such changes, and may not implement them until the same is approved.

當選用的材料、零件或者產品功能的改變可能影響到醫療器械產品安全性、有效性時，應當評價因改動可能帶來的風險，必要時采取措施將風險降低到可接受水平，同時應當符合相關法規的要求。
In the event that any change to the selected materials, parts or product functions may affect the safety and effectiveness of any medical device, the manufacturer shall evaluate the risks which may arise from such change, and if necessary,take measures to reduce the risks to an acceptable degree, meanwhile, pursuant to the requirements set out in relevant regulations.

第三十八條 企業應當在包括設計和開發在內的產品實現全過程中，制定風險管理的要求并形成文件，保持相關記錄。
Article 38 In the whole process, including the product design and development, the manufacturer shall establish the risk control requirements and formulate corresponding documents,and maintain relevant records.

第七章 采 購
Chapter VII Procurement

第三十九條 企業應當建立采購控制程序，確保采購物品符合規定的要求，且不低于法律法規的相關規定和國家強制性標準的相關要求。
Article 39 Manufacturers shall establish procurement control procedure to ensure that the procured articles conform to the requirements specified, which shall at least meet the relevant provisions in laws and regulations and relevant coercive national mandatory standards.

第四十條 企業應當根據采購物品對產品的影響，確定對采購物品實行控制的方式和程度。
Article 40Manufacturers shall validate the way and degree of control on procured articlesaccording to the procured articles’ effect on products.

第四十一條 企業應當建立供應商審核制度，并應當對供應商進行審核評價。必要時，應當進行現場審核。
Article 41 Manufacturers shall establish supplier review system and carry out review and evaluation on the suppliers in which carrying out on-spot review when necessary.

第四十二條 企業應當與主要原材料供應商簽訂質量協議，明確雙方所承擔的質量責任。
Article 42Manufacturers shall conclude and sign Quality Agreement with the suppliers ofmain raw materials clarifying the quality responsibilities of both sides.

第四十三條 采購時應當明確采購信息，清晰表述采購要求，包括采購物品類別、驗收準則、規格型號、規程、圖樣等內容。應當建立采購記錄，包括采購合同、原材料清單、供應商資質證明文件、質量標準、檢驗報告及驗收標準等。采購記錄應當滿足可追溯要求。
Article 43 In case ofprocurement, manufacturers shall clarify procurement information and clearlydescribe procurement requirements, including the category of procured articles,acceptance criteria, models and specifications, procedures and drawings.Procurement records shall be established, including Procurement Contract, listof raw materials, supporting documents of supplier’s qualification, qualitystandards, testing report and acceptance criteria. Procurement records shall meetthe requirements for traceability.

第四十四條 企業應當對采購物品進行檢驗或者驗證，確保滿足生產要求。
Article 44 The manufacturer shall inspect or verify any articles procured thereby so as to ensure that they meet the manufacturing requirements.

第八章 生產管理
Chapter VIII Manufacture Management

第四十五條 企業應當按照建立的質量管理體系進行生產，以保證產品符合強制性標準和經注冊或者備案的產品技術要求。
Article 45 Manufacturers shall carry out manufacture according to established quality management system to ensure that the products conform to mandatory standards as well as product technical specification registered or filed.

第四十六條 企業應當編制生產工藝規程、作業指導書等，明確關鍵工序和特殊過程。
Article 46 Manufacturers shall compile manufacturing process procedures and operation instructions, and clarify critical process and special process.

第四十七條 在生產過程中需要對原材料、中間品等進行清潔處理的，應當明確清潔方法和要求，并對清潔效果進行驗證。
Article 47 Where raw materials, work-in-progress require to be cleaned during the manufacturing process, cleaning method and requirements shall be clarified, and cleaning effect shall be verified.

第四十八條 企業應當根據生產工藝特點對環境進行監測，并保存記錄。
Article 48 Manufacturers shall carry out environment monitoring according to manufacturing process features and maintain the records.

第四十九條 企業應當對生產的特殊過程進行確認，并保存記錄，包括確認方案、確認方法、操作人員、結果評價、再確認等內容。
Article 49 Manufacturers shall validate the special manufacturing process and maintain the records, including validation plan, validation method, operators, result evaluation and re-validation, etc.

生產過程中采用的計算機軟件對產品質量有影響的，應當進行驗證或者確認。
Where computer softwareused in the manufacturing process has effect on the product quality, theverification or validation shall be carried out.

第五十條 每批（臺）產品均應當有生產記錄，并滿足可追溯的要求。
Article 50 There shall be manufacturing record for each batch (set) of products which can meet the requirements for traceability.

生產記錄包括產品名稱、規格型號、原材料批號、生產批號或者產品編號、生產日期、數量、主要設備、工藝參數、操作人員等內容。
Manufacturing records shall include the product name, model and specification,batch number of raw materials, manufacturing batch number or product ID,manufacturing date, quantity, main equipment, technological parameters and operators.

第五十一條 企業應當建立產品標識控制程序，用適宜的方法對產品進行標識，以便識別，防止混用和錯用。
Article 51 Manufacturers shall establish product identification control procedure and identify the products with appropriate method to facilitate identification and prevent mixing and misuse.

第五十二條 企業應當在生產過程中標識產品的檢驗狀態，防止不合格中間產品流向下道工序。
Article 52 Manufacturers shall indicate the inspection status of products during manufacturing process to prevent the nonconforming work-in-progress from flowing to next procedure.

第五十三條 企業應當建立產品的可追溯性程序，規定產品追溯范圍、程度、標識和必要的記錄。
Article 53 Manufacturers shall establish a procedure for the traceability of products and specify its scope, degree, identification and necessary records.

第五十四條 產品的說明書、標簽應當符合相關法律法規及標準要求。
Article 54 The product instruction for use and labels shall conform to relevant laws and regulations as well as standards.

第五十五條 企業應當建立產品防護程序，規定產品及其組成部分的防護要求，包括污染防護、靜電防護、粉塵防護、腐蝕防護、運輸防護等要求。防護應當包括標識、搬運、包裝、貯存和保護等。
Article 55 Manufacturers shall establish product protection procedure and specify the protection requirements for products and their components, including requirements for pollution protection, electrostatic protection, dust protection, corrosion prevention and transportation protection, etc. The protection shall include identification, transportation, packaging, storage and protection, etc.

第九章 質量控制
Chapter IX Quality Control

第五十六條 企業應當建立質量控制程序，規定產品檢驗部門、人員、操作等要求，并規定檢驗儀器和設備的使用、校準等要求，以及產品放行的程序。
Article 56 Manufacturers shall establish quality control procedure specifying requirements for product inspection department, personnel and operation, and requirements for the use and calibration of inspection instruments and equipment as well as product release procedure.

第五十七條 檢驗儀器和設備的管理使用應當符合以下要求：
Article 57 The management and use of inspection instruments and equipment shall conform to the following requirements:

（一）定期對檢驗儀器和設備進行校準或者檢定，并予以標識；
(1) Carry out calibration or verification of inspection instruments and equipment periodically and identify them;

（二）規定檢驗儀器和設備在搬運、維護、貯存期間的防護要求，防止檢驗結果失準；
(2) Specify the protection requirements for the inspection instruments and equipment during their transportation, maintenance and storage to prevent the inaccuracy of inspection results;

（三）發現檢驗儀器和設備不符合要求時，應當對以往檢驗結果進行評價，并保存驗證記錄；
(3) Where inspection instruments and equipment failing to meet the requirements, evaluate the previous inspection results and maintain verification records;

（四）對用于檢驗的計算機軟件，應當確認。
(4) Validate the computer software used for inspections.

第五十八條 企業應當根據強制性標準以及經注冊或者備案的產品技術要求制定產品的檢驗規程，并出具相應的檢驗報告或者證書。
Article 58 Manufacturers shall develop inspection procedures of products according to mandatory standards as well as product technical specification registered or filed, and issue corresponding inspection report or certificate.

需要常規控制的進貨檢驗、過程檢驗和成品檢驗項目原則上不得進行委托檢驗。對于檢驗條件和設備要求較高，確需委托檢驗的項目，可委托具有資質的機構進行檢驗，以證明產品符合強制性標準和經注冊或者備案的產品技術要求。
The incoming inspection, process inspection and finished product inspection projects requiring routine control shall not be entrusted for inspection in principle. Where the projects have comparatively high requirements for inspection conditions and equipment needing entrusted inspection, a qualified institution may be entrusted to carry out inspections so as to prove that products conform to mandatory standards as well as product technical specification registered or filed.

第五十九條 每批（臺）產品均應當有檢驗記錄，并滿足可追溯的要求。檢驗記錄應當包括進貨檢驗、過程檢驗和成品檢驗的檢驗記錄、檢驗報告或者證書等。
Article 59 Each batch(set) of products shall be accompanied with such inspection records that can be traceable. Such incoming records shall include any inspection records, testing reports or certificates arising out of incoming inspection, process inspection and finished product inspection.

第六十條 企業應當規定產品放行程序、條件和放行批準要求。放行的產品應當附有合格證明。
Article 60 Manufacturers shall specify product release procedure, conditions and requirements for release approval. Certificate of Conformance shall be attached for the products released.

第六十一條 企業應當根據產品和工藝特點制定留樣管理規定，按規定進行留樣，并保持留樣觀察記錄。
Article 61 Manufacturers shall formulate administrative provisions for sample retention according to product and process features, retain the samples according to relevant provisions and maintain the observation records of retention samples.

第十章 銷售和售后服務
Chapter X Sales and After-sales Service

第六十二條 企業應當建立產品銷售記錄，并滿足可追溯的要求。銷售記錄至少包括醫療器械的名稱、規格、型號、數量；生產批號、有效期、銷售日期、購貨單位名稱、地址、聯系方式等內容。
Article 61 Manufacturers shall establish product sales records meeting the requirements for traceability which shall at least include: the name, specification, model and quantity of medical devices; batch number, expiry date, distribution date,the name, address and contact of procuring units, etc.

第六十三條 直接銷售自產產品或者選擇醫療器械經營企業，應當符合醫療器械相關法規和規范要求。發現醫療器械經營企業存在違法違規經營行為時，應當及時向當地食品藥品監督管理部門報告。
Article 63 The manufacturer,which sells or retains a medical device distributing enterprise to sell any products manufactured by it, shall comply with the relevant medical devices regulations and rules. Upon their awareness of any distributing activities by such medical device distributing enterprise in violation of any laws or regulations, the manufacturer shall promptly report to the local food and drug regulatory authority.

第六十四條 企業應當具備與所生產產品相適應的售后服務能力，建立健全售后服務制度。應當規定售后服務的要求并建立售后服務記錄，并滿足可追溯的要求。
Article 64 Manufacturers shall be equipped with after-sales service ability adapted to the products manufactured, and establish and improve after-sales service system.They shall specify the requirements for after-sales service and establish after-sales service record, and meet the requirements for traceability.

第六十五條 需要由企業安裝的醫療器械，應當確定安裝要求和安裝驗證的接收標準，建立安裝和驗收記錄。
Article 65 Where the medical devices need to be installed by manufacturers, manufacturers shall validate the installation requirements and acceptance criteria for installation and verification and establish installation and acceptance record.

由使用單位或者其他企業進行安裝、維修的，應當提供安裝要求、標準和維修零部件、資料、密碼等，并進行指導。
Where the medical devices are installed and repaired by consumption units or other enterprises, manufacturers shall provide installation requirements,criteria, components and parts,material, password etc., and provide guidance.

第六十六條 企業應當建立顧客反饋處理程序，對顧客反饋信息進行跟蹤分析。
Article 66 Manufacturers shall establish the customer feedback handling procedure, and carry out follow-up analysis on customer feedback information.

第十一章 不合格品控制
Chapter XI Control of Nonconforming Products

第六十七條 企業應當建立不合格品控制程序，規定不合格品控制的部門和人員的職責與權限。
Article 67 The manufacturer shall establish control procedures of non-conforming products and define the responsibilities and authorities of the departments and personnel controlling nonconforming products.

第六十八條 企業應當對不合格品進行標識、記錄、隔離、評審，根據評審結果，對不合格品采取相應的處置措施。
Article 68 The manufacturer shall mark, record, isolate and review any non-conforming products and take corresponding disposal measures against them based on the review results.

第六十九條 在產品銷售后發現產品不合格時，企業應當及時采取相應措施，如召回、銷毀等。
Article 69 Where manufacturers discover products nonconforming after sale, they shall promptly take corresponding measures, such as recall or destruction, etc.

第七十條 不合格品可以返工的，企業應當編制返工控制文件。返工控制文件包括作業指導書、重新檢驗和重新驗證等內容。不能返工的，應當建立相關處置制度。
Article 70 Where nonconforming products may be reworked, manufacturers shall develop control document of rework including the contents of operation instruction,re-inspection and re-verification, etc. Where nonconforming products cannot be reworked, manufacturers shall establish relevant disposal systems.


第十二章 不良事件監測、分析和改進
Chapter XII Adverse Events Monitoring, Analysis and Improvement

第七十一條 企業應當指定相關部門負責接收、調查、評價和處理顧客投訴，并保持相關記錄。
Article 71 Manufacturers shall assign relevant department to receive, investigate,evaluate and handle customer complaints and maintain relevant records.

第七十二條 企業應當按照有關法規的要求建立醫療器械不良事件監測制度，開展不良事件監測和再評價工作，并保持相關記錄。
Article 72 Manufacturers shall establish the medical device adverse event monitoring system in accordance with relevant laws and regulations, carry out monitoring and re-evaluation of adverse events and maintain the relevant records.

第七十三條 企業應當建立數據分析程序，收集分析與產品質量、不良事件、顧客反饋和質量管理體系運行有關的數據，驗證產品安全性和有效性，并保持相關記錄。
Article 73 Manufacturers shall establish the data analysis procedure, collect and analyze the data related to the product quality, adverse event, customer feedback and operation of quality management system, verify the safety and effectiveness of products,and maintain relevant records.

第七十四條 企業應當建立糾正措施程序，確定產生問題的原因，采取有效措施，防止相關問題再次發生。
Article 74 The manufacturer shall establish corrective action and procedures to validate the cause of any problem and take efficient measures to prevent the re-occurrence of such problem.

應當建立預防措施程序，確定潛在問題的原因，采取有效措施，防止問題發生。
The manufacturer shall establish preventive measures and procedures to validate the cause of any potential problem and take efficient measures to prevent such problem from happening.

第七十五條 對于存在安全隱患的醫療器械，企業應當按照有關法規要求采取召回等措施，并按規定向有關部門報告。
Article 75 For the medical devices with potential safety hazards, manufacturers shall take measures such as recall, etc. in accordance with relevant laws and regulations,and report to relevant authorities in accordance with relevant provisions.

第七十六條 企業應當建立產品信息告知程序，及時將產品變動、使用等補充信息通知使用單位、相關企業或者消費者。
Article 76 Manufacturers shall establish the notification procedure of product information and promptly inform consumption unit, enterprises or consumers concerned of supplementary information such as product change and usage, etc.

第七十七條 企業應當建立質量管理體系內部審核程序，規定審核的準則、范圍、頻次、參加人員、方法、記錄要求、糾正預防措施有效性的評定等內容，以確保質量管理體系符合本規范的要求。
Article 77 The manufacturer shall establish internal review procedures for the quality management system and specify the requirements for reviewing rules, scope, frequency,participants, method, records, as well as evaluation on the effectiveness of corrective and preventive action so as to ensure that the quality management system meets the requirements in the GMP.

第七十八條 企業應當定期開展管理評審，對質量管理體系進行評價和審核，以確保其持續的適宜性、充分性和有效性。
Article 78 The manufacturer shall perform regular management review, through which the quality management system may be evaluated and reviewed, to ensure its continuous suitability,sufficiency and effectiveness.

第十三章 附 則
Chapter XIII Supplementary Provisions

第七十九條 醫療器械注冊申請人或備案人在進行產品研制時，也應當遵守本規范的相關要求。
Article 79 Where medical devices registration applicant or filing applicant conducting product development, they shall also comply with the relevant requirements in the GMP.

第八十條 國家食品藥品監督管理總局針對不同類別醫療器械生產的特殊要求，制定細化的具體規定。
Article 80 CFDA shall formulate detailed provisions for different categories of medical devices according to their respective manufacturing requirements.

第八十一條 企業可根據所生產醫療器械的特點，確定不適用本規范的條款，并說明不適用的合理性。

Article 81 The manufacturer may identify those inapplicable provisions in the GMP according to the characteristics of the medical devices manufactured thereby and explain the reasons.

第八十二條 本規范下列用語的含義是：
Article 82 Thefollowing terms in the GMP are defined as:

驗證：通過提供客觀證據對規定要求已得到滿足的認定。
Verification: the affirmation that the requirements specified have been satisfied through providing objective evidence.

確認：通過提供客觀證據對特定的預期用途或者應用要求已得到滿足的認定。
Validation: the affirmation that specific intended use or application requirements have been satisfied through providing objective evidence.

關鍵工序：指對產品質量起決定性作用的工序。
Critical process: refers to the process that plays decisive role in product quality.

特殊過程：指通過檢驗和試驗難以準確評定其質量的過程。
Special process: refers to the process the quality of which is hard to be correctly evaluated through inspections and tests.

第八十三條 本規范由國家食品藥品監督管理總局負責解釋。
Article 83 The GMP shall be explained by CFDA.

第八十四條 本規范自2015年3月1日起施行。原國家食品藥品監督管理局于2009年12月16日發布的《醫療器械生產質量管理規范（試行）》（國食藥監械〔2009〕833號）同時廢止。

Article 84 The GMP shall come into force as of March 1, 2015, and the Good Manufacturing Practice for Medical Devices (Interim) (GSYJX[2009] No. 833) published by the former CFDA on December 16, 2009 shall be abolished simultaneously.