Medical Device Quality Systems Manual
A Small Entity Compliance Guide First Edition (Supersedes the
Medical Device Good Manufacturing Practices [GMP] Manual):
Complaints
INTRODUCTION
Section 820.3(b) of the Quality Systems regulation defines a complaint as "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution." All medical device manufacturers are subject to the complaint requirements in 21 CFR Part 820, Quality System regulation and to the reporting requirements in 21 CFR Part 803, Medical Device Reporting (MDR) regulation. A complaint is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. A complaint may be lodged against any finished device that had been released for distribution. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications is subject to the provisions of 21 CFR 820.198, Complaint Files.
The sources of oral and written complaints are numerous. A manufacturer can receive this information via telephone, facsimile, written correspondence, sales representatives, service representatives, scientific articles, and FDA or internal analyses. Information will also be submitted by health care professionals, lay users, consumers, user facilities and distributors on the MedWatch Forms FDA 3500 and FDA 3500A.
Manufacturers are required to review, evaluate, and, when appropriate, investigate complaints, establish and maintain written procedures describing the process used to perform these activities, and designate a responsible individual or entity to perform these tasks. Complaints concerning death, serious injury or malfunctions, as defined in the MDR regulation, shall be reported to FDA as discussed later. Manufacturers of any class of medical devices are never exempted from the Quality System regulation complaint requirements (820.198) nor the general record requirements (820.180) which permit FDA review and copying of these records. Complaint file requirements are necessary to make certain manufacturers have adequate quality systems for investigating complaints and
taking corrective action. Access to complaint files, device-related death and injury reports, and complaints about device defects enables FDA to determine if a manufacturer's quality system and corrective actions are adequate.
Manufacturers can identify problems with device component, labeling and packaging quality by several methods. To meet all GMP requirements these identification methods should include a review and evaluation of all complaints, failed devices, and service or repair requests. Complaints and service or repair requests are important sources of feedback information for a quality system. Finished devices that are returned for service or repair may meet the complaint requirements identified in section 820.198; therefore, these service or repair requests shall be evaluated to determine if they are complaints. Service or repair data shall be reviewed [820.200(b)&(e)] to identify systematic problems and problems that may qualify as complaints. When these problems are identified they should be processed as complaints according to the requirements in 820.198.
Complaint data, in conjunction with product audits, QA systems audits, operational analyses, inspection and test data, etc., is used by the quality assurance organization to:
z identify poor performance in the overall quality system, particularly faulty design of devices, and faulty manufacturing processes;
z aid in implementing solutions to these quality problems;
z verify confidence in, and improve the performance of the quality system;
z improve the safety and performance of devices;
z reduce medical device reporting;
z reduce costs and improve production schedules;
z reduce employee confusion;
z improve customer relations by reducing the frequency of problems, complaints, and recalls;
and,
z assure compliance with device regulations and consensus standards.
Complaint Handling System
An effective complaint handling system is an extremely important part of any quality system. Even manufacturers who have not received complaints should be prepared to receive and process them. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective actions shall be taken. The
results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution.
Using written procedures for handling complaints increases confidence that all complaints will be handled properly. Written procedures should be provided to employees to facilitate communication, maintain consistency, and reduce quality problems. Written procedures for the receiving, reviewing and evaluating of complaints by a formally designated unit shall be established and maintained in accordance with 820.198, Complaint Files, and 820.40, Document Controls, respectively. The procedures should include the need for complaints to be evaluated in accordance with 820.100, Corrective and Preventive Action.
The complaint files shall be maintained in accordance with the general record keeping requirements of 820.180. All complaint files are to be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution bythe manufacturer. The written procedure should specify: authority; responsibilities; and the process to follow in receiving, reviewing, and investigating complaints. However, for very small manufacturers where division of work is minimal, and authorities and responsibilities are obvious, the GMP requirements as detailed in 820.198 in conjunction with appropriate forms may be sufficient as a protocol for handling complaints.
Although FDA does not specify a standard complaint handling system, the GMP requirements do specify certain actions that shall be included in any system. Manufacturers shall: z document, review, evaluate, and file all complaints;
z formally designate a unit or individual to perform these activities;
z determine if an investigation is necessary;
z record the reason if no investigation is made;
z assign responsibility for deciding when not to investigate; and,
z determine if the complaint requires an MDR report.
Complaint Responsibility
Manufacturers shall formally assign responsibility for maintaining complaint files and conducting complaint investigations to individuals or an organizational unit. Under 820.25(b) it is the manufacturer's responsibility to ensure that personnel are properly trained to adequately perform their duties. These employees shall have the proper education and training to process complaints. Any difficulty noted in employees performing required tasks for proper complaint handling may be an indication that additional training is needed. Training shall be documented.
The person(s) assigned to review complaints should have a thorough knowledge of the product line in order to make an informed, reasonable decision as to the severity and significance of a complaint and to decide whether an investigation is necessary. If it is decided that an investigation is not necessary, a record shall be made of the rationale used to arrive at this decision. The record must identify the individual responsible for making this decision.
Executive management should ensure that adequate resources are provided, including trained personnel, to the designated complaint handling unit within the company. The activities of the unit should be assessed on a regular basis, and corrections made if necessary.
MDR Reportable Complaints
Section 820.198(c) specifically requires that any complaint involving the possible failure of a device, labeling, or packaging to meet its performance specifications shall be reviewed, evaluated, and investigated unless such investigation has already been performed for a similar complaint and another investigation is not necessary. Also, section 820.198(d) further specifies that any complaint that requires an MDR report shall be promptly reviewed, evaluated, and investigated by a designated individual(s), and shall be maintained in a separate portion of the complaint files or clearly identified. However, if maintained separately a manufacturer should duplicate these serious complaints in the regular complaint file to assure that any analysis performed by product is inclusive of all complaints. Analysis by appropriate statistical methodology where necessary is a means of identifying quality problems. A single event, of course, may also be an indicator of a quality problem.
Complaint Records
FDA does not specify a standard method for recording or retrieving complaint information. Each manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets requirements of
the Quality System regulation. A two sided form is suggested when using hard copy to record complaints. One side may be used to record complaint information such as:
z sequential number of the complaint;
z origin of the complaint;
z customer information;
z product information;
z any corrective actions already taken;
z details of the complaint;
z and dates, signatures, assignments, etc.
The other side may be used to record:
z instructions;
z investigations;
z analyses;
z conclusions;
z corrective action with respect to the product and to the customer;
z and dates, signatures, etc.
A typical form is exhibited at the end of this chapter. The completed form should be stored in the complaint file which may be a physical or electronic file.
Investigation Records
The designated unit or person(s) responsible for maintaining the complaint file(s) shall prepare
a written record of any investigations. This record shall include [820.198(e)]:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
Also, the investigation record of any complaint that is being reported to FDA in an MDR report shall include a determination of [820.198(e)]:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis; and
(3) The relationship, if any, of the device to the reported incident or adverse event.
Section 820.198(e) requires the record of investigation to include any reply to the complainant. Manufacturers should send a reply to each complainant as a courtesy, but more important to prevent further misuse, injury or other adverse situations from recurring. However, because of the nature of the complaint, there may be cases where a reply is not necessary. In such cases, the record should state that no reply was made and the reason for not replying. When the problem was caused by misuse, it is very important to advise the user to help prevent further misuse. Also, the manufacturer should determine if inadequate labeling may have lead to misuse.
File Accessibility and Location
The GMP requirement states in 820.180 that "All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of the Food and Drug Administration designated to perform inspections." "All records" includes complaint files and records of investigations. For complaint processing, responsible officials are general managers, complaint processors, QA managers, R&D and process engineers, and others who receive, process, investigate, and correct problems associated with complaints. Complaint files shall be reasonably accessible to FDA for review and copying. FDA has clear authority under Section 704(e) of the Food, Drug, and Cosmetic Act to inspect and copy all records required under section 519 of this Act.
The GMP requirement states that complaint files must be handled by a formally designated complaint unit. If the unit or individual(s) designated as responsible for investigating complaints is located away from the actual manufacturing site, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing site. If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at a location in the United States where the manufacturer's records are regularly kept or at the location of the original distributor.
When devices are produced for a manufacturer by a contract manufacturer, the manufacturer should forward to the contractor copies of complaints and investigations that pertain to operations performed by the contractor. The contractor should maintain a complaint file and process complaints as discussed herein for the primary manufacturer.
Relabelers, importers, and others who distribute under their own name should forward complaints to the actual manufacturers, including foreign manufacturers, who are usually in the best position to resolve complaints on their own products.
Non-medical Complaints
Certain manufacturers products may be used both as a medical device and for non-medical uses, for example lasers and motors. The complaints received from non-medical users do not necessarily have to be included in complaint files. However, if the non-medical product fails to meet specifications, then that report should be in the manufacturer's complaint file. This action would help assure compliance with 820.100, which requires identifying, recommending, or providing solutions for quality problems and verifying implementation of such solutions. The person receiving such complaints shall be trained [820.25(b)] to identify complaints that also affect those units used as medical devices.
Complaint Analysis
To facilitate detection of failure or defect trends, complaint files should be arranged in a manner that permits correlating present and past complaints for a particular product or product line. Thus, files are usually organized according to product or product lines. Manufacturers who do not organize complaint files by product or product line may have to search several files to find similar complaints or indications to identify problem trends. Complaints may be maintained in a computer file so that complaint data on a specific device or type of complaint can be readily accessed and analyzed. As appropriate, complaint analysis or their summaries should be included in the management review and the quality system [820.20(c)].
DEVICE FAILURE ANALYSIS
Manufacturers should process and analyze failed devices per 820.100. Section 820.100(a)(1) states that returned product is subject to corrective action. Failure analysis must be conducted by appropriately trained and experienced personnel [820.25(b)]. They should use a written procedure to assure that the process of device handling and analysis will not compromise the determination of the cause of the device failure. The failure investigation and analysis should determine the actual failure mechanism to the objective level necessary to correct the problem. When systematic failure
has been diagnosed and corrective action established, a manufacturer need not analyze all additional devices that are returned with the same symptoms.
If a failure is determined to be related to safety and effectiveness, the deficiency should be determined, corrected and documented. If an investigation verifies a particular device deficiency and that this deficiency may exist in other products, the investigation should extend to determining its effect on other medical products.
Any corrective or preventive action taken shall be done following the requirements in 820.100.
FEEDBACK FOR QA SYSTEM
The more comprehensive a quality system is, the lower the probability of complaints occurring. However, in order for a quality assurance system to be dynamic or self correcting, data on quality problems from all sources should be fed back into the system. Complaints are a valuable source of data that can point to corrective actions.
Feedback data should flow into all operations that could be affected by the data and should be used to aid in device and process design evaluation and/or redesign, and to aid in improving the overall quality system program.
Regardless of the size of the formal quality system, the feedback data path in any company should be the same, that is, the data should flow into all affected operations even if some of these are not covered by the formal quality system or by FDA regulations.
COMPLAINT SOURCES
Complaints that shall be processed according to the GMP requirements may be received from: z customers by letter, credit memo, returned goods form, or phone;
z a manufacturer's representative, or other employees;
z the MedWatch voluntary reporting program;
z a service or repair request;
z journal articles; or
z the FDA.
Complaints from any source shall be equally addressed by and be processed according to the company complaint policy and procedure. The company should make certain that market, sales,
engineering, manufacturing, regulatory, installation, and service personnel are trained to properly identify and report complaints. These employees shall be made aware of this requirement according to section 820.25(b).
MEDICAL DEVICE REPORTING
In addition to the GMP requirements covering complaint handling and failure investigations, device manufacturers shall also comply with the Medical Device Reporting (MDR) regulation, 21 CFR Part 803.
Who Must Report
The MDR regulation requires that all manufacturers of medical devices notify FDA when they become aware of a death or serious injury that may have been caused or contributed to by one of their marketed devices and/or any malfunction of one of their devices which, if it were to recur, would be likely to cause or contribute to a death or serious injury. These are the same complaints that the Quality System regulation requires a manufacturer to place in a separate portion of the complaint file or otherwise clearly identify [820.198(d)]. The MDR regulation is intended to supplement the Quality System regulation -- it is not meant to replace the GMP complaint and failure investigation requirements.
When to Report
There are specific time limits within which the MDR reports shall be made. Any report of a device-related death, serious injury and malfunction shall be submitted within 30 calendar days from becoming aware of an MDR reportable event. To meet these requirements, manufacturers shall have an information handling system to assure that data are screened to determine what shall be reported to FDA. This system shall also be able to follow up this information quickly and accurately in order to comply with the MDR regulation. Manufacturers which have a good system for processing complaint and failure investigations such as described in this chapter will have the organization and data processing capabilities to meet the MDR requirements.
Manufacturers of medical devices are required to report a device related death, serious injury or malfunction to FDA using FDA Form 3500A, within 30 calendar days after becoming aware of the event. However, if the event necessitates remedial action to prevent an unreasonable risk of substantial harm to public health, then a report shall be submitted within 5 work days. Reports shall
also be submitted when FDA notifies a manufacturer that 5-day reports involving a particular type of medical device or type of event are required.
The reporting process starts when an MDR reportable event is first recognized. Manufacturers are responsible for making sure their employees know how to recognize what may be reportable. Manufacturers should also emphasize that any employee may learn of an adverse event during a phone call, a sales visit, a professional conference, from correspondence received or from
service/warranty orders.
Individual Adverse Event Reports
There are two types of individual adverse event reports that may be submitted by manufacturers. The 5 work day and 30 calendar day reports.
The 5-day report (803.53) is for MDR reportable event(s) that require a remedial action to prevent an unreasonable risk of substantial harm to the public health or where FDA has specified that a 5-day report is needed. This situation may be identified by the manufacturer or FDA: z If the manufacturer identifies the event and initiates a remedial action to prevent an unreasonable risk of substantial harm to the public health, a 5-day report is submitted
instead of the 30-day report. Information not available within the five days should be
provided in a supplemental report.
z If FDA identifies the event, the manufacturer will receive a written request directing them to file a 5-day report for all subsequent events of the same nature that involve
similar devices for a specified time period. The FDA identification may be a result of its
review of 30-day reports, inspection reports, user facility reports, etc.
The 5-day period of reporting starts the day after any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
The MDR regulation defines remedial action as any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrence of a reportable event.
Not all remedial actions need to be submitted as 5-day reports. Only remedial actions that are necessary to prevent an unreasonable risk of substantial harm to the public health shall be submitted.
If a remedial action is taken, but it is not done to prevent an unreasonable risk of substantial harm to the public health a 5-day report is not required. A 30-day report, however, may be required.
The discovery that a remedial action is necessary may be a direct result of one or more MDR reportable events occurring, or may be discovered through the performance of internal analyses using appropriate statistical or other acceptable methodologies for processing data.
Actions taken to fix a single device involved in the MDR reportable event are not remedial actions.
A 30-day report is required once a manufacturer receives or otherwise becomes aware of information that reasonably suggests that a device they have marketed:
(1) has or may have caused or contributed to a death or serious injury; or
(2) has malfunctioned and such device or similar device marketed by the manufacturer would
be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.
The 30-day period for reporting starts the day after receipt by any employee of information that reasonably suggests that an MDR reportable event has occurred. FDA expects manufacturers to train their employees to recognize that they have received information on an adverse event and to know to whom in the company to forward this information for an MDR evaluation.
A manufacturer is NOT required to file an MDR report:
z when it determines that a device related event did not occur, or
z when it determines that the device was made by another manufacturer.
For the latter instance, the regulation requires the manufacturer to forward whatever information they have to FDA with a cover letter explaining that they did not manufacture the device so that FDA can send it on to the correct manufacturer. In this case, a 3500A should not be completed. Manufacturers may also voluntarily send a copy of this information to the manufacturer they identify as being the actual manufacturer.
Written MDR Procedures
In addition to having general complaint handling procedures, the MDR regulation(803.17) requires manufacturers to develop, maintain and implement written MDR procedures that at a minimum:
A. Set up internal systems for:
z timely and effective identification, communication, and evaluation of any events that may be MDR reportable;
z a standardized review process/procedure for determining when an event meets the criteria for reporting under the MDR regulation; and
z timely transmission of a complete MDR report to FDA.
B. Set up documentation and recordkeeping for:
z information that was evaluated to determine if an event was MDR reportable;
z all MDR reports and information submitted to FDA;
z any information that was evaluated when preparing the annual certification report; and z systems that ensure access to information that facilitates timely follow up and inspection by FDA.
The MDR procedures should be either incorporated in the overall complaint handling procedure or be a companion to it. In either case these MDR procedures shall be clearly identified. If a companion procedure, it shall be incorporated by reference in the overall procedure. This will assure that all complaints are properly evaluated for MDR reporting.
Each manufacturer has certain discretion to determine the level of detail and depth of information that their written MDR procedures contain. FDA suggests that manufacturers provide policy and interpretation information regarding "typical" adverse events or product problems that may be MDR reportable. FDA also suggests that the procedures describe the investigation protocol that will be followed, e.g., two or three or four attempts will be made to contact the reporter either by phone, FAX or letter before an investigation is closed; that the complaint records will contain a concise but thorough description of the adverse event or product problem, that the complaint records will be legible, etc.
MDR Event Files
Each event that requires a determination regarding its MDR reportability shall be documented in an MDR event file (MEF) (803.18). This MEF will be one of the bases for establishing compliance with the requirements of the MDR regulation. Files are to be accessible to FDA personnel for review and evaluation, be as complete as possible, and are to clearly document MDR related actions and decisions. The following information should be in the MEF to assure that it complies with the MDR requirements:
a) The original or a copy of the initial record complaint/event. This record should include
the available information needed to complete the Form FDA 3500A. The record may be
documentation of a telephone call, a letter or facsimile, a service report, documents
related to a lawsuit, a voluntary FDA 3500 received from a health care professional or
consumer, or mandatory FDA 3500A received from a User Facility and/or a Distributor,
etc.
b) Copies of any records documenting the manufacturer's attempts to follow-up and obtain
missing or additional information about the event. When information cannot be obtained
an explanation shall be made part of the file.
c) Copies of any test reports, laboratory reports, service records and reports, records of
investigation, etc.
d) Copies of all documentation involving the final assessment of the event, any
deliberations and/or decision making processes used to determine whether an MDR
report was or was not needed. When applicable, the final assessment should indicate
what action, if any, the manufacturer has taken to assure that the cause of the event is
corrected or otherwise mitigated.
e) Copies of all FDA 3500A forms submitted to FDA, when applicable. This includes a
copy of any FDA 3500A forms received from User Facilities and Distributors.
f) Documents verifying that the event has been evaluated in accordance with the applicable
requirements of the QS regulation, sections 820.100 and 820.198.
g) References to any other relevant documents or information used during assessment. How To Maintain MDR Event Files
The MEF can be written or electronic files. They may make reference to other information that was used during the investigational process, in lieu of copying and maintaining duplicates in the file. Any referenced material is to be made available to FDA personnel for review, copying and verification.
Each MEF shall be retained for a period of two (2) years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. Each MEF file shall be maintained for this period of time even if the device is no longer sold/distributed by the manufacturer.
The MEF may be maintained as part of the complaint file required by 21 CFR Section 820.198, however, the MEF files shall be prominently identified.
ADDITIONAL MDR GUIDANCE
Manufacturers should refer to the guidance document entitled, "Medical Device Reporting for Manufacturers," for further information on how to comply with this requirement.
There is also a Web page devoted to MDR issues.
REPORTS OF REMOVALS AND CORRECTIONS
At the time of completion of this manual, FDA has not published a final rule implementing its authority under section 519(f) of the Act to require reports of removals and corrections. It is important to note, however, that the agency published a proposal to implement this authority at 59 FR 13828 (March 23, 1994). A final rule based on the proposed rule may require reporting different from or in addition to that required by the Quality System and MDR regualtions.
EXHIBITS
Exhibits are described below which follow in the order described.
Complaint Processing Procedure and Forms
This sample procedure is used to establish and help implement a system for processing routine complaints for devices. The customer complaint form mentioned in the sample procedure is essentially the same as the form, "customer/device complaints," in the next exhibit. Nowadays the complaint log shown on sheet 3 of 5 is easily maintained on a computer.
An example of a complaint recording form follows the complaint processing procedure.
The form titled "Customer Complaint" can be used to record most complaints.
If it matches a manufacturer's needs, the complaint form may be used as is. Also, it may be modified to meet specific needs. If the form is modified or a new one is developed, a manufacturer should make sure the resulting form is consistent with the GMP requirements and consistent with any complaint handling policy and/or procedures being used at the manufacturer.
MedWatch Forms
A copy of the MedWatch 3500A is included at the end of this chapter. This form may be photocopied for submitting reports.
The MedWatch 3500A is also available from the Web page devoted to MDR issues.
*** SAMPLE PROCEDURE ***
C O M P A N Y L O G O Sheet 1 of 5 Title Complaint Processing Procedure SOP Number
Prepared by Date Prepared
Approved by Date Rev
ECN Notes
PURPOSE: To establish and implement a procedure and forms for recording customer complaints, analysis, response, and corrective action.
POLICY: It is the policy of our company that all complaints regarding safety, performance, or quality of our products or services will be subject to management review and/or investigation and will result in prompt response and corrective action where indicated.
SCOPE / DEFINITION: This policy is applicable to and must be complied with by all personnel who receive a customer complaint, including personnel in Sales and other departments.
A "complaint" is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Thus, any written, oral, or returned goods expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of any device manufactured by this manufacturer would be considered a complaint.
Types of complaints intended to be covered by this policy are as follows:
1.PRODUCT PERFORMANCE: the product in some way does not perform to user's expectation or to any level of performance conveyed to the customer by printed labeling or verbally by company employees.
2.PRODUCT SAFETY: all safety complaints are covered by this procedure.
3. PRODUCT RELIABILITY: failure rate or need for service adjustments greater than user expectation, i.e. beyond the tolerable level of expected wear or malfunction.
4.PRODUCT APPEARANCE: visual defects inconsistent with the user's expectations for a medical device.
5.GENERAL COMPLAINTS: order or shipping error, delayed or unacceptable response to problems, unfulfilled promises, etc.
6. MDR REPORTABLE COMPLAINTS: all complaints involving device-related deaths, serious injuries and malfunctions. (See Policy/Procedure No. XXX for handling of MDR reports.)
FORMS USED: Customer/Device Complaint and Analysis and Complaint Log
PROCEDURE: Upon receipt of a customer complaint, the recipient completes side one of a CUSTOMER/DEVICE COMPLAINT form and, if the complaint is written, attaches the complaint letter to the form. The recipient then gives the form, with any attachments, by the next day to the Manager of Quality Assurance.
*** SAMPLE PROCEDURE Sheet 2 of 5
IMPORTANT COMPANY POLICY: Where a complaint requires immediate corrective action or response to a customer, the complaint recipient must either take the required action or communicate with the proper person to take the required action. It is the responsibility of the recipient of any complaint to see that the customer receives a response -- nothing in the following procedure relieves him or her of this responsibility.
Quality Assurance:
1. Assigns a sequential complaint number and enters the complaint into the Complaint Log.
2. Determines and notes on the complaint form the person to whom the complaint is to be assigned
for investigation and/or corrective action and the date a response is required from the assignee.
3. Notes any specific instructions to the assignee.
4. Distributes a copy to appropriate Department(s) as checked on side 1 of the complaint form.
5. Makes 2 copies of all sides of the inprocess form and attachments, and distributes:
Original to the Assignee.
One copy to the "UNDER INVESTIGATION" complaint folder.
The Assignee:
1. Performs the investigation and/or corrective actions and records the results on the form; and
attaches any investigation records. If no investigation was done the reason why must be recorded and the name of the approving official documented.
2. Returns the original of the inprocess form to QA.
Quality Assurance:
1. Records on the Analysis side:
If no action is taken, the reason for inaction should be recorded on the analysis form.
Any additional corrective action taken or directed by QA.
Whether an MDR report was submitted to the FDA.
The nature and date of any response made to the originator or the customer. If this response is written, a copy of the letter or FAX is attached to the analysis form.
The final disposition of the complaint.
QA signature and date.
2. Records the final disposition of the complaint on the complaint log.
3. Files the completed form in the appropriate complaint file for the type of device involved; and
discards the copy previously filed in the "UNDER INVESTIGATION" complaint folder.
1.Distributes the complaint log monthly to Staff and specifically involved departments. This
log should include a trend analysis of complaints for the month correlated with trends noted in previous months.
*** SAMPLE RECORD ***
COMPLAINT LOG Sheet 3 of 5 MONTH , 19
Seq. No. Date
Rec=d.
Type
Device
COMPLAINT DISPOSITION
*** SAMPLE RECORD*** Sheet 4 of 5 of Procedure No. _________________
CUSTOMER COMPLAINT (Side 1) SEQUENTIAL NO. __________________________
Device Name _______________________________________ Model Number __________________ Catalog Number ____________________________________ Lot Number _______________________ Distributor___________________________________________________________________________ Name of Complainant ________________________________ Phone No. ________________________ Complainant Address __________________________________________________________________ Complaint Received by _________________________________________________________________ Title ______________________________________________ Date Received ____________________ By: Q Visit Q Phone Q Letter Q Sales Q Credit Memo Q Other _________________________________ COMPLAINT ABOUT
Q Sterility __________________________________________________________________________
Q Particulate Matter Type ________________ Location ____________________________________
Q Defect ________________________________________________________________
Q Packaging _______________________________________________________________
Q Labeling ________________________________________________________________
Q Patient Death ___________________________________________________________
Q Patient Injury ____________________________________________________________
Q Product Malfunction ________________________________________________________
Q Other (specify) ___________________________________________________________
Comments/Description of Event ________________________________________________
______________________________________________________________________
____________________________________________________________________
ATTACHMENTS Q Implicated Sample Q Associated Sample Q Letter
Received By QA Mgr ________________________________ Date ________________________________ Assigned To _______________________________________ Response Due ________________________ Instructions
____________________________________________________________________________________
____________________________________________________________________________________
_____________________________________________________________________________________ Distribution: Q Quality Control Q Engineering Q Production Q QA Q Sales Q Service
*** SAMPLE RECORD*** Sheet 5 of 5 of Procedure No. _________________
CUSTOMER ANALYSIS (Side 2) SEQUENTIAL NO. __________________________
Device Name ____________________________________ Model Number __________________________ Catalog Number __________ Lot Number ____________ Date of Complaint Report ___________________ Name of Complainant _____________________________________________________________________ Nature of Complaint ______________________________________________________________________ ASSIGNEE EVALUATION
Date(s) Evaluation
Performed______________________________________________________________________ Evaluation
Results_______________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
Q Copy of evaluation attached
CONCLUSIONS
Q Device Defective Q Device Failed to Meet Specifications Q Improper Use
Q Shipping Damage Q Repair Request
Q Other(specify)
_______________________________________________________________________________
_______________________________________________________________________________ ACTION/REPLY TO COMPLAINANT
?None. Reason for no action ______________________________________________________ ?____________________________________________________________________________
Q Recalled. FDA phoned on - Date ______________ Spoke to ___________________________
Q Complaint Committee Informed on - Date ___________________ Q MDR Filed on - Date
__________________
Q Referred to _________________________________ for Further Investigation or Correction
标题21-食物和毒品 第一章-食品和药物管理局 卫生和人类服务部 第h章-医疗设备 第820部分质量体系监管 A部分----一般规定 秘书。820.1范围。 (a)适用性。（1）本质量体系条例规定了现行良好制造做法要求。本部分的要求指导所有用于人类使用的成品设备的设计、制造、包装、标签、储存、安装和维修所使用的方法以及所使用的设施和控制。本部分的要求旨在确保成品设备将是安全和有效的，否则符合联邦食品、药品和化妆品法案（该法案）。本部分确立了适用于成品医疗器械生产厂家的基本要求..如果制造商只从事符合本部分要求的某些操作，而不是其他操作，则该制造商只需遵守适用于其所从事操作的要求。关于I类设备，设计控制只适用于820.30(A)（2）中列出的设备。本条例不适用于部件制造商或成品设备部件制造商，但鼓励这些制造商使用本条例的适当规定作为指导。用于输血或进一步制造的血液和血液成分的制造商不受本部分的限制，但受本章F节的限制。本章第1271.3(d)段所界定的人体细胞、组织、细胞和组织产品制造商，即医疗设备（根据该法的设备规定提交的申请或根据《公共卫生服务法》第351节提交的生物产品许可证申请，须接受市场前审查或通知，或免于通知），均须遵守本章第1271节C部分所规定的供者资格程序适用本章第1271节D部分现行良好做法程序。如果第1271部分和本章其他部分中的适用条例发生冲突，则具体适用于该装置的条例应取代较一般的条例。 （2）本部分的规定适用于在美国任何州或领土、哥伦比亚特区或波多黎各自由邦制造、进口或提供进口的本部分所界定的供人类使用的任何成品装置。 （3）本条例多次使用“酌情”一词。如果一项要求被“酌情”限定，则被认为是“适当的”，除非制造商可以另有证明。如果合理地预期不实施会导致产品不符合其规定的要求或制造商无法采取任何必要的纠正行动，则要求是“适当的”。 (b)本部分的质量体系条例补充了本章其他部分的规定，但另有明确说明的除外。如果本部分的适用法规与本章其他部分发生冲突，则具体适用于该装置的法规应取代任何其他普遍适用的要求。 (c)权力。第820部分是在该法第501、502、510、513、514、515、518、519、520、522、701、704、801、803节的授权下设立和发布的(21U.S.C。351、352、360、360c、360d、360e、360h、360i、360j、360l、371、374、381、383)。未能遵守本部分的任何适用规定，使设备在该法第501(H)节中掺假。这种装置以及任何不遵守规定的责任人都要受到管制。 (d)外国制造商。如果提供进口到美国的设备的制造商拒绝允许或允许完成食品和药物管理局(FDA)对外国设施的检查，以确定是否符合这一部分，则为该法第801(a)条的目的，应表明该法中使用的方法以及用于设计、制造、包装、标签、储存、安装的设施和控制，或维修在该设施生产的任何设备，而这些设备是提供进口到美国的，不符合该法第520(F)节和本部分的要求，以及该设施制造的设备是根据该法第501(H)节掺假的。 (e)豁免或差额。（1）任何人如欲申请豁免或更改任何设备质量体系要求，须遵守该法第520(f)（2）条的规定。豁免或差异的申请应按照本章第10.30条规定的程序，即FDA的行政程序提交。可从食品和药物管理局、设备和放射卫生中心、小制造商司、国际和消费者援助司、新罕布什尔州大道10903号，Bldg获得指导。66，RM。4613，银弹簧，MD20993-0002，1-800-638-2041或301-796-7100，传真：301-847-8149。 （2）当机构确定这种差异符合公共卫生的最佳利益时，林业发展局可根据任何设备质量系统的要求提出和批准差异。只有在公共卫生对该装置仍有需要的情况下，而且在没有这种差异的情况下不可能充分提供该装置，这种差
FDA医疗器械质量体系手册 When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation. 当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。 Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation. 附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，FDA认为它们是成品器械因为它们可以使用于或作用于并且销售来为健康相关的目的；并且QS法规要应用When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation. 当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。 Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation. 附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，因为它们可以使用于或作用于并且销售来为健康相关的目的，FDA认为它们是成品器械；并且QS法规要应于其生产。同样的，装置或零件包括软件是作为成品医疗器械的附加部分销售的，以增加或补充其性能，也作为附件器械对待。既然医疗器械的附件是作为成品来对待，因而受QS法规制约。
美国FDA 医疗器械体系法规QSR820中文版Part 820——质量体系法规——目录 Subpart A- 总则 820.1 范围 820.3 定义 820.5 质量体系 Subpart B –质量体系要求 820.20 管理职责 820.22 质量审核 820.25 人员 Subpart C- 设计控制 820.30 设计控制 Subpart D- 文件控制 820.40 文件控制 Subpart E- 采购控制 820.50 采购控制 Subpart F- 标识与可追溯性 820.60 标识 820.65 可追溯性 Subpart G - 生产和过程控制 820.70 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确认 Subpart H - 验收活动: 820.80 进货、过程和成品器械检验 820.86 检验状态 Subpart I –不合格品 820.90 不合格品 Subpart J - 纠正和预防措施 820.100 纠正和预防措施 Subpart K –标识和包装控制 820.120 设备标签 820.130 设备包装
Subpart L –搬运/储存/分销和安装 820.140 搬运 820.150 贮存 820.160 分销 820.170 安装 Subpart L –记录 820.180 记录的通用要求 820.181 设备主要记录 820.184 设备历史记录 820.186 质量体系记录 820.198 投诉文件 Subpart M –服务 820.200 服务 Subpart N –统计技术 820.250 统计技术 Subpart A——总则 Subpart A--General Provisions Sec.820.1 范围 Sec. 820.1 Scope. （a）适用性Applicability。 （1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。本标准的目的是保证成品器械的安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适用于所有的医疗器械成品制造商。如果制造商仅从事本部分有要求服从的某些过程而未从事其它过程，则只需符合其实施的过程的要求。对于Ⅰ类设备，设计控制仅适用于Sec.820.30（a）（2）中列出的设备。本法规不适用于成品器械的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血液成分制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。 Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others,
培训教材 美国FDA 医疗器械体系法规 QSR820中文版
Part 820——质量体系法规——目录 Subpart A- 总则 范围 定义 质量体系 Subpart B –质量体系要求 管理职责 质量审核 人员 Subpart C- 设计控制 设计控制
Subpart D- 文件控制 文件控制 Subpart E- 采购控制 采购控制 Subpart F- 标识与可追溯性 标识 可追溯性 Subpart G - 生产和过程控制 生产和过程控制 检验、测量和试验设备 过程确认 Subpart H - 验收活动: 进货、过程和成品器械检验 检验状态 Subpart I –不合格品 不合格品 Subpart J - 纠正和预防措施 纠正和预防措施 Subpart K –标识和包装控制 设备标签 设备包装 Subpart L –搬运/储存/分销和安装 搬运 贮存 分销 安装 Subpart L –记录 记录的通用要求 设备主要记录 设备历史记录 质量体系记录 投诉文件 Subpart M –服务 服务 Subpart N –统计技术 统计技术
Subpart A——总则 Subpart A--General Provisions 范围 Sec. Scope. （a）适用性Applicability。 （1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。本标准的目的是保证成品器械的安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适用于所有的医疗器械成品制造商。如果制造商仅从事本部分有要求服从的某些过程而未从事其它过程，则只需符合其实施的过程的要求。对于Ⅰ类设备，设计控制仅适用于（a）（2）中列出的设备。本法规不适用于成品器械的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血液成分制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。 （2）本部分的规定适用于本部分定义的预期用于人体的所有成品器械，不论其在美国(包含:美国任何州或领土,哥伦比亚特区,波多黎各联邦)本土制造还是进口,提供进口的产品。 （3）在本法规中“适用时”（where appropriate）出现过多次。当要求根据“where appropriate”被认为是合格时，其要求应被认为是“适用的”（appropriate），除非组织能提供文件证明其理由。如果不执行预期结果会导致产品不符合其特定的要求，或组织不需要执行任何必要的纠正措施，那么要求就是适用的（appropriate）。 （b）限制。除非特别规定，则本部分质量体系法规是本章其它部分法规的补充要求。在不能符合所有适用的法规，包括本章此部分和其它部分的情况，特别是对讨论中的设备，此法规应取代其它通用要求。 （c）权限。PART820是在（法令351、352、360、360c、360d、360e、360h、360i、360j、360l、370、374、381、383中）501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并发布的。不符合本部分（Part 820）的任何适用的规定，依据法令section 501（h）条款，可判定该产品为伪劣产品。这类产品及对此不符合负责的任何个人，将依法被起诉。 （d）外国制造商。如果把器械进口到美国的制造商拒绝允许或同意FDA对其外国工厂履行为确定器械是否符合本法规（Part 820）所进行的检查，可按section 801（a）条款对其提出诉讼。即准备出口到美国的设备，其设计、生产、包装、标签、贮存或服务中使用的方法和设备控制不符合本法令section 520（f）和本部分（Part 820）的要求，可按本法令section 501（h）条款判定在此条件下制造的产品为伪劣产品。 （e）豁免或特别许可/ Exemptions or variances （1）任何人希望得到任何医疗器械质量体系要求的豁免或特别许可，应符合法令section 520（f）（2）的要求。根据本章即FDA行政程序，来提交豁免或特别许可的申请。可以从
mds 美国FDA医疗器械法规解读 第部分 第一部分 MEDevice Services, LLC 美德思咨询公司（美国） https://www.doczj.com/doc/c16856195.html,
美国FDA是什么机构 美国食品药品监督管理局（FDA，U.S. Food and Drug Administration）为直属美国健 康及人类服务部（DHHS）管辖的联邦政府机 康及人类服务部（）管辖的联邦政府机 构，其主要职能为负责对美国国内生产及进 口的食品、膳食补充剂、药品、疫苗、生物 口的食品膳食补充剂药品疫苗生物 医药制剂、血液制剂、医学设备、放射性设 备、兽药和化妆品进行监督管理，同时也负 责执行公共健康法案(the Public Health Service Act)的第361号条款，包括公共卫 生条件及州际旅行和运输的检查、对于诸多 生条件及州际旅行和运输的检查对于诸多 产品中可能存在的疾病的控制等等。 2 MEDevice Services, LLC
美国FDA是什么机构（续） 美国健康及人类服务部（DHHS）（相当于卫生部） 国家卫生研究院（NIH） 卫生资源与服务管理局(HRSA) 保健研究与质量局(AHRQ) 印第安人卫生服务(IHS) 药品滥用及精神健康服务管理局(SAMHSA) 疾病控制及预防中心(CDC) 食品药品监督管理局(FDA) 3 MEDevice Services, LLC
美国FDA的各个部门 该管理局由若干个部门组成，每个部门都负 责一个相关领域的监管工作： ?食品安全和应用营养中心（CFSAN） ?生物制品审评和研究中心（CBER） ?药品审评和研究中心（CDER） ?设备仪器与放射健康中心（CDRH） ?兽药中心（CVM） ?国家毒理学研究中心（NCTR） ?监管事务办公室（ORA） ?另外，美国食品药品监督管理局也同包括农 业部、联邦禁毒署、美国海关和美国消费品 安全委员会等联邦部门以及州政府展开了频 繁而广泛的合作 繁而广泛的合作。 4 MEDevice Services, LLC
医疗器械法律法规及文件体系培训试题 部门：______________ 姓名：___________________ 分数：__________________ 一、填空题 1、为了加强对医疗器械的监督管理，保证医疗器械的安全、有效，保障人体健康和生命安全，制定《医疗器械监督管理条例》。 2、为规范医疗器械分类，根据《医疗器械监督管理条例》制定《医疗器械分类规则》，及局令15 号。 3、医疗器械是指：单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需的软件。 4、《医疗器械生产企业许可证》分正本和副本，正本、副本具有同等法律效力________ ，有效期为 5 年。 5、《医疗器械生产企业许可证》变更分为许可事项变更和登记事项变更。 6自2011年_7_月—1_日起，生产企业申请无菌医疗器械首次注册和重新注册时，应当按要求提交经检查合格的《医疗器械生产管理规范检查结果通知书》—，其他医疗器械的质量管理体系检查按现有规定进行。 7、为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定《医疗器械注册管理办法》。 8、医疗器械标准分为国家标准、行业标准和注册产品标准。 9、医疗器械临床验证的范围：同类产品已上市，其安全性、有效性需要进一步确认的医疗器械。 10、公司质量手册代码为QM ，程序文件代码为PR ，记录文件代码为 JL __ 。 二、简答题： 1、公司管理文件总共有几类，分别为哪些？ 8类：组织结构与人员管理；厂房设施设备管理，物料管理，卫生管理，验证管
30理，生产管理，质量管理，销售管理 2、医疗器械注册证书中哪些内容发生变化，生产企业应当自发生变化之日起日内申请变更重新注册？有五种内容发生变化，1型号规格、2 生产地址；3 产品标准；4产品性能结构及组成； 5 产品适用范围 3、《医疗器械监督管理条例》第五条国家对医疗器械实行分类管理。请简述第一类、第二类和第三类医疗器械各指的是哪类医疗器械？ 第一类：常规管理，足以保证其安全性，有效性的医疗器械第二类：对其安全性，有效性应加以控制的医疗器械第三类：植入人体用以支持维持生命对人体具有潜在危险，对其安全性，有效性必须严格控制的医疗器械。
一文读懂各国医疗器械法规框架 1. 入门：各国GMP法规综述 1）中国医疗器械监管历程 CFDA负责负责食品、药品、医疗器械、化妆品的监督管理。 2013年3月22日，"国家食品药品监督管理局"(SFDA)改名为"国家食品药品监督管理总局"(CFDA) 历任领导 局长杨寿山1978.7-1979.8 局长胡昭衡1979.8-1982.9 局长郑筱萸(1944-2007) 1994.5--2005.6死刑副局长张敬礼2003.10--2010.6 有期徒刑17年 局长邵明立2005.6--2012.2 局长尹力2012.2--2013.3 局长张勇2013.3--2015.1 局长毕井泉2015.1至今 CFDA在2014年之前并没有医疗器械全生命周期的监管思路，而是有点无面零散地发布了一些法规。在国务院650号令之后，开始系统性地按照GxP的架构发布法规。所发布的法规分为以下几个层级： 条例：650号令国务院 办法：7号令生产监督管理办法 规范：64号令GMP/附录 原则：现场检查指导原则
医疗器械全生命周期监管已进入4G时代，还缺一个GLP (Good Laboratory Practice) GCP:Good Clinical Practice |医疗器械临床试验质量管理规范 GMP:Good Manufacturing Practice |医疗器械生产质量管理规范 GSP: Good Supply Practice|医疗器械经营质量管理规范 GUP: Good Use Practice |医疗器械使用质量管理规范 与ISO13485相比，国内器械GMP的主要差异有 ?GMP是法规具有强制性，ISO是标准 ?GMP不强调“以客户关注为焦点”，不强调客户抱怨的处理要求 ?GMP要求生产和质量负责人不得兼任 ?GMP强调生产/技术/质量管理部门的负责人应当掌握法规，有能力对实际问题作出处理?GMP里没有关于顾客财产的要求 ?GMP不强调对内部审核的要求 ?GMP对不良事件报告的要求比ISO更具体 ?GMP里要求产品必须有合格证 ?GMP强调供应商审核制度，ISO偏重外包控制要求 2）新版ISO13485：2016简介 ISO13485名称：Medical devices-Quality managementsystems-Requirements for regulatory purposes 医疗器械-质量管理体系-用于法规的要求 适用对象：医疗器械设计和制造商/经营商/供应商 发布单位：医疗器械质量管理和通用要求技术委员会即ISO/TC 210 ISO13485的历史 第一版ISO13485：1996（必须与ISO9001：1994一同使用）
软科学研究项目报告 国内外医疗器械政策法规及标准 比较研究专题报告 深圳市医疗器械行业协会 2013年12月
前言 医疗器械直接关系到人民的生命安全和身体健康，为此，世界各个国家和地区都将医疗器械行业列为重点监管对象。为了确保医疗器械的安全性和有效性，各个国家和地区都制定了严格的医疗器械市场准入制度和相关的法规体系，这些法规既有相通之处，又存在许多差异。 开展国内外医疗器械政策法规及标准的对比研究，一直是医疗器械产业界及政府监管部门十分关注的热点问题，一方面有助于现代产业体系的建设与完善，促进产业结构的调整，帮助创新型自主品牌企业在国际市场中把握技术性贸易壁垒的变化发展趋势，及早采取应对措施；另一方面，从政府监管的角度来讲，也可为监管部门提供意见和建议，为进一步完善中国医疗器械法规体系提供科学的参考依据。 由于各国家和地区相关法规、标准众多，使得此类研究工作的开展十分困难。基于此，深圳市科技创新委员会和深圳市医疗器械行业协会特邀请业内资深人士、企业代表，组织研究并编写了《国际医疗器械法规研究专题报告》。这些人员均具有多年从事医疗器械法规事务方面的丰富工作经验，对各个国家和地区的法规和标准体系有着深刻的认识和理解。 本报告对国内外医疗器械监管政策法规及产品标准的现状、差异及未来的发展趋势进行对比研究，一共十二章，第一章为法规综述；第二章至第十三章分别从监管模式、医疗器械分类、标准、检测模式、临床要求、质量体系及生产监管、上市准入模式、流通监管模式、上市后监督模式，以及体外诊断试剂法规要求等方面进行对比、分析，形成专项报告。
本报告在编撰过程中得到了深圳市科技创新委员会的大力支持和指导。参加本项目的研究单位有：深圳市科技创新委员会、深圳市药品监督管理局、深圳市医疗器械行业协会、深圳迈瑞生物医疗电子股份有限公司、深圳市理邦精密仪器股份有限公司、业聚医疗器械（深圳）有限公司、先健科技（深圳）有限公司、奥咨达医疗器械咨询机构、深圳市龙德生物科技有限公司，具体撰写人员有：蔡翘梧、胡辉、黄进、乐秋红、李玲、李秀兰、柳永英、施小立、谭传斌、杨龙、张强、张晓华、张艳红、钟志辉（按姓氏排列）等。在此一并表示感谢。 本报告仅代表参加项目研究人员的个人意见，由于水平有限，时间仓促，难免有遗漏和错误之处，恳请读者批评指正，以便在今后修订完善。若读者对本报告的观点有不同看法，欢迎提出商榷。
美国的医疗器械法规体系--QSR820 美国食品药品监督管理局(FDA)是负责医疗器械管理的政府机构。其根据各相关法律授权而制定的各类法规性的文件编号为21CFRxxxx(xxxx为阿拉伯数字)。 其中21CFR820是FDA根据《联邦食品,药品和化妆品法案》第501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803条款的授权而制定的规范医疗器械企业质量体系要求的法规,即Quality System Regulation,简称QSR或QSR820。 谁要遵守QSR820? 21QSR820。1规定,所有在美国和波多黎各境内的,或者有产品出口到美国和波多黎各境内的医疗器械企业必须按QSR820的要求建立质量体系。各企业可以根据实际情况,满足QSR中与自己活动相关的条款。 QSR820不适用于医疗器械零件生产商,但FDA鼓励这类企业以QSR820中适用的条款为指导。 QSR820不适用于人血和血制品生产商。这类企业应遵循21CFR606的规定。 谁来检查企业是否符合QSR820? FDA下属的CDRH(器械与放射健康中心)是专职负责医疗器械企业管理的政府机构,其根据FDA的授权安排检查员到个企业进行工厂检查。对美国境内企业一般每两年检查一次,境外企业不定期检查。所有检查费用由FDA承担。 在欧洲和美国本土,FDA也授权TUV等第三方机构进行工厂检查,扥企业要支付相应费用。 无论谁来检查,都只是一个符合性检查,不颁发任何证书,不属于【信息咨询】活动。 如何检查企业是否符合QSR820? QSIT(质量体系检查技术)是FDA检查员的必修课程,也是FDA Quality Systems Inspection Reengineering Team专门编制的检查员手册。该文件详细介绍了检查方法,关注点,无论对FDA检查员还是企业内审员/供应商审核员都具有参考价值。
培训教材 美国FDA 医疗器械体系法规QSR820中文版 2015.06
Part 820——质量体系法规——目录 Subpart A- 总则 820.1 范围 820.3 定义 820.5 质量体系 Subpart B –质量体系要求 820.20 管理职责 820.22 质量审核 820.25 人员 Subpart C- 设计控制 820.30 设计控制
Subpart D- 文件控制 820.40 文件控制 Subpart E- 采购控制 820.50 采购控制 Subpart F- 标识与可追溯性 820.60 标识 820.65 可追溯性 Subpart G - 生产和过程控制 820.70 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确认 Subpart H - 验收活动: 820.80 进货、过程和成品器械检验820.86 检验状态 Subpart I –不合格品 820.90 不合格品 Subpart J - 纠正和预防措施 820.100 纠正和预防措施 Subpart K –标识和包装控制 820.120 设备标签 820.130 设备包装 Subpart L –搬运/储存/分销和安装 820.140 搬运 820.150 贮存 820.160 分销 820.170 安装 Subpart L –记录 820.180 记录的通用要求 820.181 设备主要记录 820.184 设备历史记录 820.186 质量体系记录 820.198 投诉文件 Subpart M –服务 820.200 服务 Subpart N –统计技术 820.250 统计技术
医疗器械质量管理体系用于法规的要求医疗器械质量管理体系用于法规的要求 0 引言 0.1总则 本标准规定了质量管理体系要求，组织可依此要求进行医疗器械的设计和开发、生产、安装和服务以及相关服务的设计、开发和提供。 本标准也可用于内部和外部(包括认证机构)评定组织满足顾客和法规要求的能力。注:是理解或说明有关要求的指南。 值得腔调的是，本标准所规定的质量管理体系要求是对产品技术要求的补充。 采用质量管理体系应当是组织的一项战略性决策，一个组织的质量管理体系的设计和实施受各种需求、具体目标、所提供的产品、所采用的过程以及该组织的规模和结构的影响。统一质量管理体系的结构或文件不是本标准的目地。 医疗器械的种类很多，本标准中所规定的一些专用要求只适用于指定的医疗器械类别。本标准第3章规定了这些类别的定义。 0.2过程方法 本标准以质量管理的过程方法为基础。 任何得到输入并将其转化为输出的活动均可视为过程。 为使组织有效运作，必须识别和管理众多相互关连的过程。 通常，一个过程的输出将直接形成下一个过程的输入。 组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。 0.3与其他标准的关系 0.3.1与GB/T19001的关系 本标准是一个以GB/T19001为基础的独立标准。
那些从GB/T19001中不加更改而直接引用的章或条采用宋体字表示，这些未作更改的条见附录B。 本标准的文本与GB/T19001的文本不同，文本中包含的变化的句子或排版全部以黑色宋体字标准，更改内容的性质和原因见附录B。 0.3.2与ISO/TR14969的关系 ISO/TR14969是一个旨在为YY/T0287的应用提供指南的技术报告。 0.4 与其他管理体系的相容性 为了方便医疗器械行业的使用者，本标准遵循了GB/T19001的格式。 本标准不包括针对其他管理体系的要求，如环境管理、职业卫生与安全管理或财务管理的特定要求。 然而本标准使组织能够将其自身的质量管理体系与相关的管理体系要求结合或整合。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。 1 1.范围 1.1总则 本标准为需要证实其有能力提供持续满足顾客要求和适用于医疗器械和相关服务的法规要求的医疗器械和相关服务的组织规定了质量管理体系要求。 本标准的主要目地是便于实施协调的质量管理体系的法规要求。因此，本标准包含了一些医疗器械的专用要求，删减了GB/T19001中不适于作为法规要求的某些要求。由于这些删减，质量管理体系符合本标准的组织不能声称符合GB/T19001标准，除非其质量管理体系还符合GB/T19001中所有的要求。(见附录B) 1.2应用 本标准的所有要求是针对提供医疗器械的组织，不论组织的类型或规模。
美国医疗器械FDA认证流程 一、美国医疗器械FDA认证介绍 FDA对医疗器械的管理通过器械与放射健康中心进行的,中心监督医疗器械的生产、包装、经销商遵守法律下进行经营活动。医疗器械范围很广,小到医用手套,大至心脏起博器,均在FDA监督之下,根据医疗用途和对人体可能的伤害,FDA将医疗器械分为Ⅰ、Ⅱ、Ⅲ类,越高类别监督越多. 如果产品是市场上不曾存在的新颖发明,FDA要求厂家进行严格的人体实验,并有令人信服的医学与统计学证据说明产品的有效性和安全性。 医疗器械的FDA认证,包括:厂家在FDA注册、产品的FDA登记、产品上市登记(510表登记)、产品上市审核批准(PMA审核) 医疗保健器械的标签与技术改造、通关、登记、上市前报告,须提交以下材料:(1)包装完整的产成品五份,(2)器械构造图及其文字说明,(3)器械的性能及工作原理;(4)器械的安全性论证或试验材料,(5)制造工艺简介,(6)临床试验总结,(7)产品说明书. 如该器械具有放射性能或释放放射性物质,必须详细描述. 医疗器械的工厂和产品注册FDA对医疗器械有明确和严格的定义,其定义如下:“所谓医疗器械是指符合以下条件之仪器、装置、工具、机械、器具、插入管、体外试剂及其它相关物品,包括组件、零件或附件:明确列于National Formulary或the Unite States Pharmacopeia或前述两者的附录中者;预期使用于动物或人类疾病,或其它身体状况之诊断,或用于疾病之治愈、减缓与治疗者;预期影响动物或人体身体功能或结构,但不经由新陈代谢来达到其主要目的者”。 只有符合以上定义的产品方被看作医疗器械,在此定义下,不仅医院内各种仪器与工具,即使连消费者可在一般商店购买之眼镜框、眼镜片、牙刷与按摩器等健身器材等都属于FDA 之管理范围。它与国内对医疗器械的认定稍有不同。 根据风险等级的不同,FDA将医疗器械分为三类(Ⅰ,Ⅱ,Ⅲ),Ⅲ类风险等级最高。FDA将每一种医疗器械都明确规定其产品分类和管理要求,目前FDA医疗器械产品目录中共有1,700多种。任何一种医疗器械想要进入美国市场,必须首先弄清申请上市产品分类和管理要求。 FDA针对医疗器械制订了许多法案,并不时地进行修改和补充,但根本的法案并不多,主要包括:联邦食品、药品与化妆品法案(FD&C Act,根本法案);公众健康服务法案;公正包装和标识法案;健康和安全辐射控制法案;安全医疗器械法案;现代化法案。对这些法案,FDA给予了非常详细的解释,并配套有具体的操作要求。企业在计划进入美国市场前,需仔细评估针对自己产品相关的法规和具体要求(包括不同的美国产品标准要求)。 在明确了以上信息后,企业就可以着手准备有关的申报资料,并按一定程序向FDA申报以获取批准认可。对于任何产品,企业都需进行企业注册(Registration)和产品列名(Listing)。对Ⅰ类产品(占47%左右),实行的是一般控制(General Control),绝大部分产品只需进行注册、列名和实施GMP规范,产品即可进入美国市场(其中极少数产品连GMP也豁免,极少数保留产品则需向FDA递交510(K)申请即PMN(Premarket Notification));对Ⅱ类产品
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《医疗器械监督管理条例》（国务院令第650号） 2014年03月07日发布 《医疗器械监督管理条例》已经2014年2月12日国务院第39次常务会议修订通过，现将修订后的《医疗器械监督管理条例》公布，自2014年6月1日起施行。 总理李克强 2014年3月7日 医疗器械监督管理条例 （2000年1月4日中华人民共和国国务院令第276号公布 2014年2月12日国务院第39次常务会议修订通过） 第一章总则 第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。 第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。
第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。 第四条国家对医疗器械按照风险程度实行分类管理。 第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。 第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。 第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。 评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。 国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。医疗器械分类目录应当向社会
法律法规试题 一、单选题（15题，每题1分） 1、省、自治区、直辖市(食品)药品监督管理部门应当在受理之日起( )个工作日内作出是否核发《医疗器械经营企业许可证》的决定。 A、10 B、15 C、20 D、30 答案： D 2、从事医疗器械生产活动，非必须具备的条件是：( ) A、有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员； B、有对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备； C、产品标准 D、有保证医疗器械质量的管理制度； 答案：C 3、第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，不用提交的资料( ) A、仓库地址的地理位置图、平面图、房屋产权证明（或租赁协议）复印件产品、技术要求； B、产品检验报告； C、注册产品标准 答案：A 4、医用中心制氧系统按医疗器械的结构特征、使用状态分类，为( ) A、有源医疗器械、接触或进入人体器械 B、有源医疗器械、非接触人体器械 C、无源医疗器械、接触或进入人体器械 D、无源医疗器械、非接触人体器械 答案：B 5、涂改、倒卖、出租、出借医疗器械注册证书，或者以期货形式非法转让医疗器械注册证书的，由县组以上（食品）药品监督管理部门责令改正，可以并处( )罚款。 A、5000元以上10000万以下 B、5000元以上20000万以下 C、3万元以下 答案： C 6、医疗器械注册产品标准的法律责任主体是( ) A、医疗器械制造商 B、技术监督管理部门 C、医疗器械注册产品标准复核备案部门 答案： A 7、医疗器械使用状态可分为接触或进入人体器械和非接触人体器械，属于非接触人体器械的内容是：( ) A、对医疗效果的影响，其程序分为：基本不影响；有间接影响；有重要影响 B、使用时限分为：暂时使用；短期使用；长期使用
FDA 质量体系规范-中文版(QSR820 1.1 概述 §820.1 范围 (a 适用性 (1 在这个质量体系规范中描述了现行的生产管理规范的要求(CGMP. 本规范要求 规定了所有医用器械成品在设计,制造,包装,标签,贮存,安装和服务中使用的方法, 设施和控制.这些要求是为了确保医疗器械成品的安全和有效,并遵从美国食品,药品 和化妆品法.本规范提出了适用于医疗器械成品制造商的基本要求.如果某制造商只进行本规范规定的一部分操作,而不进行其他操作,则该制造商仅需执行适用于他所进行操作的那些要求.有关Ⅰ类器械,设计控制仅按在§820.30(a(2中列出的要求进行.这个规范不适用于成品组件和零件的制造商,但鼓励这样的制造商使用规范的适当规定作为指导.人类血液制品和血液成分的制造商不属于本规范的管理范围,但属于606的管理范围. (2 这一规范的规定适用于本规范定义的医疗器械成品,即使用的对象是人的,在美 国各州或领地,哥伦比亚特别区或波多黎哥联邦制造,进口或出口的器械成品. (3 在本规范中,几次使用了短语”适当的地方”.当要求以”适当的地方”来限制时,如果制造商没有合理的理由来证明不适宜,就认为此要求是”适当的”.如果不 贯彻”适当的”要求,就会导致产品达不到要求或制造商不能采取某些必要的正确措施. (b 范围 这一的质量体系规范和增补在这一规范其他节的条文明确注明用于其他方面的条文除外. 在不可能执行全部适用条文(包括这一节的和这一规范其他节的条文的情况下,特定的运用于有问题器械的条文将取代其他一般的适用条文.
(c 权威性根据联邦法501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803, (21U.S.C.315, 352, 360, 360c,360d,360e,360h,360i,360j, 360l, 371, 374, 381, 383 建立和提出了820规范的权威性. 如果没能执行适用规 范,可能会导致产生伪劣器械, 根据法规501(h, 对这样的器械和未能执行规范的 人都要进行处罚. (d 外国制造商如果某制造商提供给美国的进口器械,拒绝接受FDA 对外国设备进行是否执行本规范的检查,就会出现法规的801(a节中的后果. 用这样的设备生产出的任何器械,在设计,制造,包装, 标签,贮存,安装或服务方面,使用方法,设备和控制都未遵从法规的 520(f节和本规范的要求. 根据法规501(h, 用这样的设备制造 出来的器械都属于伪劣产品. (e 豁免或更改 (1 任何希望豁免或更改执行某些器械质量体系要求的申请,都要遵从法规 520(f(2的要求. 申请豁免或更改的过程将依据这一规范§10.30的程序进行,即FDA 的管理程序. 以下地址可提供指导: 器械和放射卫生中心, 小制造商处 (HFZ-220, 1350 Picca rd Dr.,Rockville,MD20850, U.S.A. 电话: 1-800-638- 2041或1-301-443-6597, FAX 301-443-8818. (2 当FDA判定某种更改有益于公众健康时, 就会起草并认可这项更改. 这种更改仅能在一段时间内维持有效, 即当器械仍能满足公众健康需要, 并且如果没有更改, 器械不可能制造得非常有效的一段时间内. §820.3 定义 (a法指的是美国食品,药品和化妆品法修正案(secs.201~903, 52Stat.1040et seq., 修正版21U.S.C.321~394.在法201中的全部定义都适用于本规定.