Au Aida medical device consulting organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, Jinan, the United States) is the only focus on the field of medical equipment medical device regulatory consulting organization
Medical device production quality management standard (for trial)
Chapter I General Provisions
Article I In order to strengthen the supervision and management of medical device production, standardize In order to strengthen the supervision and management of medical device production, standardize the medical device production quality management system, according to the "supervision and management of medical devices regulations" and related regulations, the formulation of this specification.
Second, this specification is the basic guidelines for the production of medical devices quality management system, applicable to the design and development of medical devices, production, sales and service of the whole process.
Article 3 The medical device manufacturer (hereinafter referred to as the manufacturer) should be based on the characteristics of the product, in accordance with the requirements of this specification, the establishment of quality management system, and maintain effective operation. As a component of the quality management system, the production enterprise shall implement risk management in the whole process of product realization.
Chapter II Management
Article 4 The production company should establish the appropriate organizational structure, the responsibilities of each agency, authority, clear quality management functions. Production management and quality management department shall not be responsible for each other.
Article 5 The person in charge of the production enterprise shall have and perform the following duties:
(1) organization to develop the quality policy and quality objectives of the production enterprise;
(2) organization to plan and determine the realization of the product process to ensure that it meets the customer's requirements;
(3) to ensure that the quality management system for the effective operation of the necessary human resources, infrastructure and working environment (d) organization and implementation of management review and keep records;
(e) designate people and departments responsible for the collection of relevant laws and regulations, to ensure that the corresponding laws and regulations are implemented within the production enterprise.
Article 6 The person in charge of the production enterprise shall determine a manager's representative. Manager's representative is responsible for the establishment, implementation and maintenance of the quality management system, report on the operation of the quality management system and the need for improvement, and improve the awareness of employees to meet the regulations and customer requirements.
Chapter III Resource Management
Article 7 The person in charge of the production, technology and quality management departments shall be familiar with the medical device-related regulations, have practical experience in quality management, and have the ability to make correct judgment and deal with the actual problems in production and quality management.
Article VIII of the personnel engaged in work affecting product quality, shall undergo appropriate technical training, with relevant theoretical knowledge and practical skills.
Article IX of the production enterprises should have and maintain the production site, production equipment, monitoring and measuring devices, storage sites and other infrastructure required for the production of products, as well as the working environment. Production environment should be in line with relevant regulations and technical standards.
Chapter IV Documentation and Records
Article 10 The production company shall establish a quality management system and the formation of documents. Quality management system documents should include the quality policy and quality objectives, quality manual, the requirements of this specification prepared by the program documents, technical documents, operating instructions and records, as well as other documents required by law.
Quality manual should be the production enterprise quality management system to make commitments and provisions.
Article XI of the production enterprise shall prepare and maintain the production of medical devices and technical documentation. Including product specifications, production process specifications, inspection and test specifications, installation and service specifications.
Article XII The manufacturer shall establish document control procedures and documents, stipulating the following document control requirements:
(1) documents should be reviewed and approved before release to ensure that the documents are appropriate and adequate and meet the requirements of this specification;
(2) when the documents are updated or revised, they should be reviewed and approved in accordance with the provisions of the regulations, and be able to Identify the status of changes and revisions to documents, and ensure that the applicable version of the document is available at the work site;
(c) The manufacturer shall ensure that relevant medical device regulations and other foreign documents are identified and controlled;
(d) The manufacturer shall mark retained obsolete documents to prevent incorrect use.
Article XIII of the production enterprises shall retain the invalidated technical documents, and determine its retention period to meet the needs of product maintenance and product quality responsibility traceability.
Article XIV of the production enterprises shall establish record management procedures and documents, the record labeling, storage, protection, retrieval, retention period, disposal requirements. Records shall meet the following requirements:
(a) the records are clear, complete, easy to identify and retrieve, and to prevent breakage and loss;
(b) the period of time for which the manufacturer keeps the records is at least equivalent to the life span of the medical device specified by the manufacturer, but not less than 2 years from the date of release of the product by the manufacturer or in accordance with the requirements of the relevant laws and regulations, and traceability.
Chapter V Design and Development
Article 15 The manufacturing enterprise shall establish design control procedures and documents to implement planning and control of the design and development process of medical devices.
Article XVI of the production enterprises in the design and development planning, should determine the design and development of the stage and the review of each stage, verification, validation and design conversion and other activities, should identify and determine the activities and interfaces of the various departments of the design and development of a clear division of responsibilities and labor.
Article 17 The design and development inputs shall include the function, performance and safety requirements for the intended use, regulatory requirements, risk management control measures and other requirements. Design and development inputs shall be reviewed and approved, and relevant records shall be maintained.
Article 18 The design and development output shall meet the input requirements and provide the basis for procurement, production and service, product characteristics and acceptance criteria. Design and development output shall be approved and relevant records shall be maintained.
Article 19 The manufacturer shall carry out design and development to production conversion activities in the design and development process, so that the design and development output can be verified before becoming the final product specifications to ensure that the design and development output is suitable for production.
Article 20 The manufacturer shall arrange for reviews at appropriate stages of design and development, and keep records of the results of the reviews and any necessary measures.
Article 21 The manufacturer shall verify the design and development to ensure that the design and development output meets the input requirements, and keep records of the verification results and any necessary measures.
Article 22 The production enterprise shall confirm the design and development to ensure that the product meets the specified applicable requirements or the requirements of the intended use, and maintain records of the confirmation results and any necessary measures.
Confirmation may be by clinical evaluation or performance evaluation. Clinical trials should be conducted in accordance with the requirements of the medical device clinical trial regulations.
Article 23 The manufacturer shall identify and maintain records of changes in design and development. If necessary, the design and development changes should be reviewed, validated and confirmed, and approved before implementation.
Elected materials, parts or product functionality changes may affect the medical device product safety, effectiveness, should be evaluated due to changes in the risks that may be brought about, if necessary, take measures to reduce the risk to an acceptable level, and at the same time should be consistent with the relevant regulatory requirements.
Article 24 The manufacturer shall, in the whole process of product realization, including design and development, formulate risk management requirements and documents, and maintain relevant records.
Chapter VI Procurement
Article 25 A production enterprise shall establish and document procurement control procedures to ensure that the products procured comply with the prescribed procurement requirements.
When the procured products are required by laws, administrative regulations and national mandatory standards, the requirements of the procured products shall not be lower than the requirements of laws, administrative regulations and national mandatory standards.
Article 26 The production enterprise shall determine the manner and degree of control to be exercised on the supplier and the purchased products in accordance with the impact of the purchased products on the subsequent product realization and the final product. When the product is entrusted to the production, the commissioning party and the entrusted party shall meet the requirements of the relevant regulations for the supervision and management of medical device production.
Producers shall evaluate the ability of suppliers to meet their procurement requirements and establish guidelines for the selection, evaluation and re-evaluation of suppliers.
Producing enterprises shall maintain records of the evaluation results and the evaluation process.
Article 27 Procurement information shall clearly express the requirements of the procurement of products, including the procurement of product categories, acceptance guidelines, specifications, specifications, drawings, if necessary, including process requirements, personnel qualification requirements, quality management system requirements.
Producers should maintain relevant procurement information according to the scope and extent of traceability requirements.
Article 28 The production enterprise shall inspect or verify the procured products to ensure that they meet the specified procurement requirements and maintain records.
Chapter VII Production Management
Article 29 Production enterprises shall plan and implement all production processes under controlled conditions.
Article 30 The production enterprises shall prepare production process regulations, operating instructions, etc., and specify the key processes and special processes.
Article 31 The production enterprises shall use appropriate production equipment, process equipment, monitoring and measuring devices, and to ensure that they are controlled.
Article 32 in the production process must be cleaned or removed from the product when the treatment, the production enterprise shall be cleaned on the product requirements for the formation of documents and implementation. Contamination of sterile medical devices should be controlled and the sterilization process.
Article 33 If the results of the production process can not or can not be easily verified by subsequent inspection and testing, the process shall be confirmed. Records of confirmation activities and results shall be maintained. Production enterprises shall identify the qualifications of process validation personnel.
If the computer software used in the production and service delivery process has an impact on the quality of the product, it should be prepared to confirm the procedural documents, to ensure that the initial application of the software, as well as any changes in the software before the application of the confirmation and record-keeping.
Article 34 The manufacturer shall establish and maintain production records for each batch of products. Production records should meet the requirements of medical device traceability, and indicate the number of production and storage quantities.
Article 35 The manufacturer shall establish the product identification control procedures and documents, clearly in the product realization of the whole process, in an appropriate way to identify the product, in order to identify, prevent mixing and misuse.
Article 36 The manufacturer shall identify the product inspection and test status, in order to ensure that in the whole process of product formation, only the required inspection and test qualified products can be released.
Article 37 The sterile medical device manufacturer shall establish the sterilization process to confirm the procedures and documents. Sterilization process should be in accordance with the relevant standard requirements before the initial implementation of confirmation, re-confirmation when necessary, and maintain the sterilization process confirmation records.
Article 38 The manufacturer shall establish traceability procedures and documents, the scope of medical device traceability, the degree of uniqueness of the logo and the required records.
Production of implantable medical devices, in specifying the traceability requirements, shall include records of all parts, components and working environmental conditions that may cause the medical device not to meet its specified requirements. At the same time the manufacturer shall require the agent or distributor to maintain a record of the distribution of the medical device for traceability purposes and to have access to this record when required.
Article 39 The instructions, labeling, packaging and marking of the product shall comply with the corresponding regulations and standards for medical devices.
Article 40 The manufacturer shall establish and document the procedures for product protection, stipulating the requirements for product protection, which shall include labeling, handling, packaging, storage and protection, and the protection shall also apply to the components of the product.
There is a storage period or special storage conditions required for medical devices and materials should be stored in accordance with the specified conditions, and keep relevant records.
Chapter VIII Monitoring and Measurement
Article 41 The manufacturer shall establish monitoring and measurement control procedures and documents, to determine the required monitoring and measurement activities, configure the appropriate devices, monitoring and measurement devices for control. Ensure that the monitoring and measurement activities comply with the following requirements:
(1) measuring devices should be regularly calibrated or calibrated and labeled, and keep records;
(2) should be stipulated in the handling, maintenance, and storage during the monitoring and measurement device protection requirements, to prevent inaccuracy of the test results;
(3) when found that the monitoring and measurement devices do not meet the requirements When the monitoring and measuring device is found to be non-compliant, the effectiveness of previous monitoring and measuring results should be evaluated and recorded. And should take appropriate measures on the device and the affected products, keep records of the device calibration and product verification results;
(d) for monitoring and measurement of computer software, before initial use should confirm its ability to meet the expected requirements, and if necessary, re-confirmation.
Article 42 The manufacturer in the product realization process at the appropriate stage, the product should be monitored and measured to verify that the product meets the specified requirements.
Article 43 A production enterprise shall release a product only after it has completed all the processes specified for product realization. The production enterprise shall release the product procedures, conditions and release of the approval of the provisions, should maintain the product meets the specified requirements of the evidence, and record the right to release the product of the personnel. Release of products should be accompanied by proof of conformity.
Article 44 The manufacturer shall establish and document a feedback procedure to monitor information on whether customer requirements have been met, and to determine the methods of obtaining and utilizing such information.
Article 45 The production enterprise shall establish the quality management system internal audit procedures and form a document, stipulating the audit guidelines, scope, frequency, participants, methods, record requirements, corrective measures to assess the effectiveness of the quality management system to determine whether the quality management system in line with the requirements of this specification and effective implementation.
Chapter IX Sales and Service
Article 46 The manufacturer shall review and keep records of the requirements related to the product, and stipulate and document the product requirements determined, such as contracts, bids, orders or product information to ensure that the manufacturer has the ability to meet these requirements. If the product requirements are changed, they shall be reevaluated and records of the evaluation shall be maintained, and the relevant documents shall be revised and notified to the relevant personnel.
Article 47 If this article applies, the manufacturer shall determine and document the acceptance guidelines for medical device installation requirements and installation verification.
When the medical device installation activities are done by personnel other than the manufacturer or its authorized agent, the manufacturer shall provide documentation of the installation and validation requirements and take appropriate control measures for the installation and validation activities.
The manufacturer shall maintain records of installation and validation completed by it or its authorized agent.
Article 48 A production enterprise shall, where there is a service requirement, specify the requirements for service activities and their validation and maintain records of the service activities performed.
Article 49 The manufacturer shall select the medical device business enterprise, shall comply with the requirements of medical device related regulations.
Article 50 The manufacturer shall establish and maintain sales records, according to the sales records should be able to trace each batch of products sold.
Chapter X Nonconforming Products Control
Article 51 The manufacturer shall establish nonconforming products control procedures and documents, the control of nonconforming products on the department and personnel responsibilities and authority.
Article 52 The production enterprise shall mark, record, isolate and evaluate the nonconforming products, and according to the evaluation results, take corresponding disposal methods for the nonconforming products.
Article 53 After the delivery of the product or start using the product is found to be unqualified, the production enterprise shall take appropriate measures.
Article 54 If the product needs to be reworked, rework documents shall be prepared, including operating instructions and re-inspection and re-evaluation of non-conforming products after rework, and shall be approved. Before the approval of rework documents shall determine the adverse effects of rework on the product.
Chapter XI Customer Complaints and Adverse Event Monitoring
Article 55 The manufacturer shall designate the relevant department responsible for receiving, investigating, evaluating and dealing with customer complaints, and maintain records.
Article 56 The manufacturer shall establish and document procedures for the issuance and implementation of advisory notices, and maintain records of issuance and implementation.
Article 57 The manufacturer shall establish adverse event monitoring procedures and documents in accordance with the requirements of the medical device adverse event monitoring and re-evaluation management, define the duties of the adverse event management personnel, and stipulate the method of collection of adverse events, reporting principles, reporting procedures and time limits.
Article 58 The manufacturer shall keep records of monitoring and re-evaluation of adverse events of medical devices and establish relevant files.
Chapter XII Analysis and Improvement
Article 59 The manufacturer shall establish data analysis procedures and documents, which provide for the collection of data related to product quality, adverse events and quality management system operation, including feedback, product quality, market information and supply-side situation.
Article 60 The production enterprise shall use appropriate analytical methods, including the application of statistical techniques, etc., to analyze data in order to determine the conformity of the product, the extent to which customer requirements have been met, and the effectiveness of the quality management system, and to maintain a record of the results of the data analysis.
Article 61 The manufacturer shall establish corrective action procedures and documents to determine and eliminate the causes of non-conformity, to take measures to prevent non-conformity from recurring, and review the effectiveness of the corrective measures taken.
Article 62 For the existence of potential safety hazards of medical devices, the manufacturer shall take measures such as recall, and report to the relevant departments in accordance with the provisions.
Article 63 The manufacturer shall establish preventive measures procedures and documents to identify and eliminate potential causes of nonconformity, take preventive measures, and evaluate the effectiveness of the preventive measures taken.
Article 64 If a manufacturer fails to take corrective and/or preventive measures in response to a customer complaint, it shall be approved and the reasons recorded.
Chapter XIII Supplementary Provisions
Article 65 The State Food and Drug Administration in accordance with the special requirements of the quality management system for the production of different categories of medical devices, will be separately formulated for the implementation of the rules for different categories of products.
Article 66 The manufacturer may, according to the characteristics of the medical devices produced, determine the provisions that are not applicable, and explain the reasonableness of the non-application.
Article 67 The meaning of the following terms in this specification is:
Customer Complaint: any claim in writing, orally, or by telecommunication, that a medical device that has been placed on the market is deficient in terms of its characteristics, quality, durability, reliability, safety and performance.
Advisory Notice: A notice issued by the manufacturer after delivery of a medical device, intended to give additional information and/or recommended actions in respect of:
-- Use of the medical device;
-- Use of the medical device;
-- Modification of the medical device;
-- Use of the medical device;
-- Use of the medical device. alteration of the medical device;
- return of the medical device to the manufacturer;
- destruction of the medical device.
Marking: a written, printed, or illustrated object.
- labeled on the medical device or on its box or packaging;
- accompanying the medical device;
information about the marking of the medical device, its technical description and instructions for use, but not including shipping documentation.
Verification: a determination that specified requirements have been met by providing objective evidence.
Confirmation: A determination that the requirements for a specific intended use or application have been met by providing objective evidence.
Surveillance: a group of operations to determine the conformity of a process, an ongoing process that refers to observing, supervising, and keeping the object under control. May include periodic measurement or testing.
Measurement: a set of operations to determine the quantitative value.
Design and Development Input: the process of documenting the intended use, function, performance requirements, safety requirements, legal and regulatory requirements, risk management, and related information related to the product requirements in the beginning stages of the design and development of the product in an adequate, appropriate, and complete manner.
Design and Development Outputs: The results of the design and development process, which refers to the transformation of product requirements into product characteristics or specifications necessary for product safety and performance, including prototypes, samples, documents, drawings, formulations, manufacturing, service and acceptance guidelines. Design and development outputs shall validate and satisfy the requirements of the design and development inputs.
Critical process: refers to the process that plays a decisive role in product quality. For example: through the processing of the formation of key, important characteristics of the process, processing difficulty, quality instability of the process.
Special process: refers to the formation of the product is qualified difficult to verify the process through subsequent monitoring and measurement.
The terms not listed in this bylaw and GB/T19001 family of standards in the term common.
Article 68 of this specification by the State Food and Drug Administration is responsible for interpretation.
Article 69 This specification shall come into force on January 1, 2011