Measures for the Supervision and Management of Medical Device Operation
Chapter I General Principles
Article 1 These measures are specially formulated to strengthen the supervision and management of medical device operation, standardize the operating behaviors of medical devices, and guarantee the safety and validity of medical devices in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 The operating activities and their supervision and management of the medical devices dealt with within the territory of the People's Republic of China should be governed by these measures.
Article 3 China Food and Drug Administration shall be in charge of the supervision and management of the medical device operation nationwide. The food and drug administration department above county level shall be responsible for the supervision and management on the medical device operation within respective jurisdiction.
Higher-level food and drug administration department shall be responsible for directing and supervising the supervision and management on the medical device operation conducted by lower-level food and drug administration department.
Article 4 Classified management shall be implemented for medical device operation according to the risk level of medical device.
The operation of Class I medical devices may be exempted from licensing and filing; filing management shall be implemented for the operation of Class II medical devices; and licensing management shall be implemented for the operation of Class III medical devices.
Article 5 China Food and Drug Administration shall formulate the good supply practice for medical devices and supervise the implementation.
Article 6 Food and drug administration department should timely publish the information on the licensing and filing for medical device operation according to law. Applicant may inquire about the progress and results of examination and approval and the public may look up the examination and approval results.
Chapter II Operation Licensing and Filing Management
Article 7 Applicant dealing with medical device operation should meet the following conditions:
(I) Possess the quality management institution or quality management personnel appropriate to the operating scale and business scope; the quality management personnel should have the professional educational background or technical title in relevant disciplines recognized by the state;
(II) Possess the operating and storage site appropriate to the operating scale and business scope;
(III) Possess the storage conditions appropriate to the operating scale and business scope.Storeroom may not be set up in case of the storage fully entrusted to other medical device operating enterprise;
(IV) Possess the quality management system appropriate to the medical devices operated;
(V) Possess the capability of professional guidance, technical training and after-sales service appropriate to the medical devices operated, or provide technical support by relevant institution as agreed.
The enterprises dealing with the operation of Class III medical devices should also have the computer information management system complying with the requirements of the GSP for medical devices to ensure the traceability of the products operated. The enterprises dealing with the operation of Class I and Class II medical devices are encouraged to establish the computer information management system complying with the requirements of the GSP for medical devices.
Article 8 The operating enterprise dealing with the operation of Class III medical devices should submit its application for the food and drug administration department of the municipality with districts and submit the following materials:
(I) Copies of business license and organization code certificate;
(II) Copies of the ID cards, educational background or professional title certificates of legal representative, responsible person of enterprise, and quality director;
(III) Explanation on the establishment of organizational structure and departments;
(IV) Explanation on business scope and business practice;
(V) Copies of the geological location map, floor plan and house ownership certificate leasing agreement (attached with house ownership certificate);
(VI) List of operating facilities and equipment;
(VII) List of documents including operating quality management system, working procedure, etc.;
(VIII) Introduction of basic information of computer information management system and explanations on functions;
(IX) Authorization certificate of agent;
(X) Other evidential materials.
Article 9 For the application for the licensing of the operation of Class III medical devices submitted by applicant, the food and drug administration department of the municipality with districts may deal with respectively according to the following situations:
(I) If the item applied is within the term of reference of the department and the application materials are complete and consistent with the legal form, the department should accept the application;
(II) If the application materials are incomplete or not inconsistent with the legal form, the applicant shall be informed of all contents to be added and/corrected in one time either on site or within five (5) working days;
(III) If the application materials have any error that can be corrected on the spot, the applicant should be allowed to make correction on the spot;
(IV) If the item applied is not falling into the term of reference of the department, the department should immediately make the decision on denial to accept the application and inform the applicant to submit application to relevant administrative department.
In case of acceptance or denial to accept the application for the licensing of medical device operation, the food and drug administration department of the municipality with districts should issue the Notice of Acceptance or Denial.
Article 10 The food and drug administration department of the municipality with districts should examine and verify the application materials within thirty (30)working days from the date of acceptance and carry out on-site verification according to the requirements of the Good Supply Practice for medical devices. In case of rectification required, the rectification time will not be included in the examination and verification time.
For those meeting specified conditions, the written decision on licensing shall be made according to laws and the License for Medical Device Operation shall be issued within ten (10) working days; for those not meeting specified conditions, if the written decision on denial is made, the reasons should be specified.
Article 11 If the application for the licensing of medical device operation directly relates to the major interest relationship between the applicant and others, food and drug administration department should inform the applicant and the interested party of the rights to apply for hearing enjoyable according to laws and regulations and the relevant provision of China Food and Drug Administration; while conducting examination of the licensing for medical device operation, food and drug administration department, if deems the application as the major licensing item relating to public interest, should announce to the public and hold a hearing.
Article 12 In case of the operation of Class II medical devices, operating enterprise should file with the local food and drug administration department of municipality with districts, fill in the Class II Medical Device Operation Filing Form, and submit the materials specified in Article 8 of these measures (except for Item 8).
Article 13 Food and drug administration department should verify the integrity of the materials submitted by enterprise on the spot; filing will be permitted for those complying with the provisions and issued with the certificate of filing for the operation of Class II medical devices.
Article 14 The food and drug administration department of the municipality with districts should carry out the on-the-spot verification on the operating enterprise of Class II medical device according to the requirements of the Good Supply Practice for medical devices within 3 months from the filing date of the medical device operating enterprise.
Article 15 The valid period of the License for Medical Device Operation is five (5) years, which shall indicate such items as license number, name of enterprise, legal representative, responsible person of enterprise, residence, site of business operation,mode of operation, business scope, address of warehouse, issuing body, issuing date, valid period, etc.
The certificate of filing for medical device operation should indicate such items as the number, name of enterprise,legal representative, responsible person of enterprise, residence, site of business operation, mode of operation, business scope, address of warehouse, filing department, filing date, etc.
Article 16 The change of the items in the License for Medical Device Operation may be classified into change of licensing item and change of registration item.
Change of licensing items includes site of business operation, mode of operation, business scope, and address of warehouse.
Change of registration items includes other items beyond aforesaid items.
Article 17 In case of change of licensing items, the application for change of the License for Medical Device Operation shall be submitted to the original issuing department.The materials relating to the change of contents as specified in the provisions of Article 8 of these measures should be submitted.
If warehouse is arranged across administrative regions, applicant should handle the filing with the food and drug administration department of the municipality with districts where the warehouse is located.
The original issuing department should verify within fifteen (15) working days after receiving the application for change and make decision on permission for change or denial for change; if on-the-spot verification should be conducted according to the requirements of the Good Supply Practice for medical devices, the decision on permission for change or denial for change shall be made within thirty (30) days after receiving the application for change. In case of denial for permission, the reasons should be specified in written and the applicant should be informed. The number and valid period of the changed License for Medical Device Operation shall remain unchanged.
Article 18 For new independent site of business operation, medical device operation licensing or filing should be applied independently.
Article 19 In case of change of registration items, medical device operating enterprise should timely handle the procedures for change with the food and drug administration department of the municipality with districts.
Article 20 The medical device operating enterprise existed due to splitting and merger should apply for change of licensing according to the provisions of these measures; the medical device operating enterprise dissolved due to splitting and merger should apply for cancellation of the License for Medical Device Operation; and the medical device operating enterprise newly established due to splitting and merger should apply for handling the License for Medical Device Operation.
Article 21 Medical device registrant,filer or manufacturing enterprise selling medical devices at their residences or manufacturing site may not handle operation licensing or filing; in case of storing at other places and selling medical devices on the spot, they should handle the operation licensing or filing according to provisions.
Article 22 If the valid period of the License for Medical Device Operation is extended upon expiration, medical device operating enterprise should submit the application for the extension of the License for Medical Device Operation with the original issuing department six months before the expiration of the valid period.
Original issuing department should verify the application for extension according to the provisions in Article 10 of these measures; if necessary, conduct on-the-spot verification, and make the decision on whether to approve the extension before the expiration of the valid period of the License for Medical Device Operation. If the application for extension that meets the specified conditions is approved,the number of the extended License for Medical Device Operation shall remain unchanged. Those not complying with the specified conditions should be instructed to make rectification within specified time; if the specified conditions still fail to meet the specified conditions after rectification. The application for extension shall not be approved and the reasons should be specified in written. If no decision is made overdue, it will be regarded as the extension is approved.
Article 23 In case of any change to the filing items such as the name of enterprise, legal representative, responsible person of enterprise, residence,site of business operation, mode of operation, business scope, address of warehouse, etc. in the filing certificate of medical device operation, the filing should be changed in a timely manner.
Article 24 In case that the License for Medical Device Operation is lost, medical device operating enterprise should immediately publish lost declaration on the media designated by the original issuing department. After 1 month after the lost declaration is published, the application for re-issuance of the certificate shall be submitted to the original issuing department. The original issuing department should timely re-issue the License for Medical Device Operation.
The number and valid period of the re-issued License for Medical Device Operation shall be the same as the original certificate.
Article 25 If the filing certificate for medical device operation is lost, medical device operating enterprise should immediately handle the procedures for re-issuance with the original filing department.
Article 26 If medical device operating enterprise is investigated by food and drug administration department due to illegal business but the case has not been closed or receives the decision on administrative sanction, the food and drug administration department of the municipality with districts should terminate the licensing until the case is completed.
Article 27 In case that the certificate of medical device operating enterprise should be canceled according to the provisions of the laws and regulations or the valid period of the license has not expired but the enterprise proposes the cancellation with initiative, the food and drug administration department of the municipality with districts should cancel the License for Medical Device Operation according to laws and publish on website.
Article 28 The food and drug administration department of the municipality with districts should establish the licensing filing such as the issuance, extension, change, re-issuance,revocation, cancellation, etc. of the License for Medical Device Operation and filing information file of medical device operation.
Article 29 Any unit and individual should not forge,alter,buy and sell,lease and lend the License for Medical Device Operation and the filing certificate of medical device operation.
Chapter III Operation Quality Management
Article 30 Medical device operating enterprise should establish the operation management system covering the whole course of quality management according to the requirements of the Good Supply Practice for medical devices and properly keep the record, and ensure the operation conditions and operation behaviors to persistently comply with the requirements.
Article 31 Medical device operating enterprise should bear the legal responsibility for the medical device buying and selling behavior committed by the administrative office or sales person in the name of the enterprise. The sales personnel of the medical device operating enterprise selling medical device should have the letter of authorization affixed with the official seal of the enterprise. The letter of authorization should indicate the variety sold under authorization, region,and time limit and indicate the ID card number of the sales person.
Article 32 Medical device operating enterprise should establish and execute the incoming inspection and recording system. The operating enterprise dealing with the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices should establish sales record system. The information of incoming inspection record and sales record should be authentic, accurate, and complete.
For the enterprise dealing with the wholesale business of medical devices, the records of purchase, storage, and sales should meet the requirements on traceability.
Incoming inspection record and sales record should be kept for 2 years after the valid period of the medical device; if valid period is unavailable, the records shall be kept for no less than 5 years. The incoming inspection record and sales record of implantable medical devices should be kept permanently.
Other medical device operating enterprises are encouraged to establish sales record system.
Article 33 Medical device operating enterprise should purchase medical devices from the manufacturing enterprise or operating enterprise with qualification.
Medical device operating enterprise should agree on quality responsibility and after-sales service responsibility with supplier to ensure the safety use of medical devices after sales.
The medical device operating enterprise agrees with supplier or appropriate institution that it will be responsible for the installation, maintenance, and technical training services of product may not establish the department dealing with technical training and after-sales service but should have appropriate management personnel.
Article 34 Medical device operating enterprise should take effective measures to ensure the transportation and storage process of medical devices to comply with the requirements of the instructions for medical devices or labels and marking, and keep proper record to ensure the safety of medical device quality.
If the instructions and label indicate that the medical devices should be stored at low temperature and in refrigeration, low-temperature, refrigeration facilities and equipment should be used for transportation and storage according to relevant provisions.
Article 35 If medical device operating enterprise entrusts other units to transport medical devices,the quality assurance capability of the medical devices transported by carrier should be assessed and evaluated,clearly defining the quality responsibility during the transportation to ensure the quality safety during transportation.
Article 36 Medical device operating enterprise, if provides storage and delivery services to other manufacturing and operating enterprises of medical devices, should sign written agreement with client, defining the rights and obligations of both parties, has the equipment and facilities appropriate to the conditions for product storage and delivery and scale,and the computer information management platform and technical means for conducting the real-time electronic data exchange and realizing the whole-course traceability of the product operation with client.
Article 37 The operating enterprise dealing with the wholesale business of medical devices should sell medical devices to the operating enterprise or user unit with qualification.
Article 38 Medical device operating enterprise should arrange full-time or part-time personnel in charge of after-sales management,find out the reasons for the quality problem complained by customer, take effective measures for timely treatment and feedback, and properly keep the record; if necessary, inform the supplier and the medical device manufacturing enterprise.
Article 39 If medical device operating enterprise has no the conditions for the original operation licensing or does not comply with the filing information and cannot be contacted, after publication by the original issuing or filing department, the License for Medical Device Operation should be canceled according to laws or indicated in the filing information of Class II medical device operation, and announced to the public.
Article 40 The operating enterprise of Class III medical device should establish quality management self-inspection system and conduct all-item self-inspection according to the requirements of the Good Supply Practice for medical devices, and submit annual self-inspection report to the local food and drug administration department of the municipality with districts at the end of each year.
Article 41 The operating enterprise of Class III medical device resumes business after self-close-down for more than one year, it should report to the food and drug administration department of the municipality with districts in written in advance; the business should not resumed until being inspected as complying with requirements.
Article 42 Medical device operating enterprise should not operate the medical devices that are not registered or filed, without qualified certificate, and out-of-date, invalid, and washed out.
Article 43 In case of major quality accident occurred on the medical device operated by medical device operating enterprise, it should report to the local food and drug administration department of the province, autonomous region or municipality directly under the central government within 24 hours, which will immediately report to China Food and Drug Administration.
Chapter IV Supervision and Management
Article 44 Food and drug administration department should regularly or irregularly conduct supervision and inspection on the compliance of medical device operating enterprise with the requirements of the Good Supply Practice and supervise and urge enterprises to standardize operating activities. The annual self-inspection report on the all-item self-inspection conducted by the operating enterprise of Class III medical devices according to the requirements of the Good Supply Practice for medical devices should be examined; if necessary, field inspection should be conducted.
Article 45 The food and drug administration department of province, autonomous region or municipality directly under the central government should compile the supervision and inspection plan for the medical device operating enterprises within respective administrative region and supervise the implementation. The food and drug administration department of municipality with districts should formulate the supervision focus, inspection frequency and coverage of the medical device manufacturing enterprise within respective administration region and organize the implementation.
Article 46 Food and drug administration department organizing supervision and inspection should formulate inspection scheme,clearly defining the inspection criteria, record the inspection conditions on the spot according to facts, and inform the inspected enterprise of the inspection results in written. If rectification is required, the rectification contents and rectification time limit should be defined and follow-up inspection should be implemented.
Article 47 Food and drug administration department should strengthen the random inspection on medical devices.
The food and drug administration department above the level of province should timely publish medical device quality announcement according to the conclusions of the random inspection.
Article 48 In any of the following circumstances, food and drug administration department should strengthen field inspection:
(I) Severe problems existed in the supervision and inspection in last year;
(II) Subject to administrative penalty due to violation of relevant laws and regulations;
(III) Class III medical device operating enterprise newly established;
(IV) Other circumstances deemed by food and drug administration department as necessary to conduct field inspection.
Article 49 Food and drug administration department should establish the routine supervision and management system for medical device operation and strengthen the routine supervision and inspection on medical device operating enterprises.
Article 50 Unannounced inspection may be implemented by food and drug administration department on the medical device operating enterprise existed with potential safety hazard of product complained and reported or indicated by other information and found out in routine supervision and inspection or the medical device operating enterprise with bad behavior record.
Article 51 In any of the following circumstances, food and drug administration department may question the responsibility of the legal representative or responsible person of medical device operating enterprise.
(I) Severe potential safety hazard existed in operation;
(II) The product operated has been reported or complained or exposed by media for several times due to quality problem;
(III) The credit rating is evaluated as the enterprise with bad credit; and
(IV) Other circumstances deemed by food and drug administration department as necessary to question the responsibility.
Article 52 Food and drug administration department should establish the archives for the supervision and management on medical device operating enterprise, record licensing and filing information, results of routine supervision and inspection,investigation and treatment of illegal act, etc.,and implement focused supervision and management on the medical device operating enterprise with bad credit record.
Chapter V Legal Responsibility
Article 53 In any of the following circumstance, the food and drug administration department above the level of county shall be instructed to make correction within time limit and warned; if the medical device operating enterprise refuses to make correction, a fine above RMB 5,000 but below RMB 20,000 shall be imposed;
(I) Medical device operating enterprise fails to handle the change of registration items according to the provisions of these measures;
(II) Medical device operating enterprise dispatching sales personnel to sell medical devices fails to provide the letter of authorization according to the requirements of these measures; and
(III) The operating enterprise of Class III medical devices fails to submit annual self-inspection report to food and drug administration department before the end of each year.
Article 54 In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and a fine above RMB 10,000 but below RMB 30,000 shall be imposed:
(I)The business conditions of medical device operating enterprise have changed and no longer complied with the requirements of the Good Supply Practice for medical device but the enterprise has not make rectification according to provisions;
(II) Medical device operating enterprise changed site of business operation or address of warehouse and expanded business scope without authorization or set up warehouses arbitrarily;
(III) The operating enterprise dealing with he wholesale business of medical devices sells medical devices to the operating enterprise or user unit without qualification; and
(IV)Medical device operating enterprise purchases medical devices from the manufacturing and operating enterprise without qualification.
Article 55 The enterprise deals with medical device operating activities without permission or fails to handle the procedures for extension according to laws but still deals with medical device operation after the valid period of the License for Medical Device Operation expires shall be punished according to the provisions in Article 63 of the Regulations on the Supervision and Management of Medical Devices.
Article 56 The enterprise providing false information or obtaining the License for Medical Device Operation with other deception means shall be punished according to the provisions in Article 64 of the Regulations on the Supervision and Management of Medical Devices.
Article 57 The enterprise forging, altering, buying and selling, leasing or lending the License for Medical Device Operation shall be punished according to the provisions in Article 64 of the Regulations on the Supervision and Management of Medical Devices.
If any enterprise forges, alters, buys and sells, leases or lends the filing certificate for medical device operation, it shall be instructed to make correction by the food and drug administration department above the level of county and a fine below RMB 10,000 shall be imposed.
Article 58 The enterprise failing to file according to the provisions of these measures or providing false information during filing shall be punished according to the provisions in Article 65 of the Regulations on the Supervision and Management of Medical Devices.
Article 59 In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and be punished according to the provisions in Article 66 of the Regulations on the Supervision and Management of Medical Devices:
(I) Operate the medical devices not complying with the compulsory standard or not complying with the technical requirements of the products registered or filed;
(II) Operate the medical devices without qualified certificate, out of date, invalid and washed out;
(III) Still refused to stop the operation of medical devices after being instructed to stop the business by food and drug administration department.
Article 60 In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and be punished according to the provisions in Article 67 of the Regulations on the Supervision and Management of Medical Devices:
(I) The instructions and labels for the medical devices operated do not comply with relevant provisions; and
(II) Failure to transport and store medical devices according the instructions and labels and marking of medical devices.
Article 61 In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and be punished according to the provisions in Article 68 of the Regulations on the Supervision and Management of Medical Devices:
(I) Operating enterprise fails to establish and execute the incoming inspection and recording system for medical device according to the provisions of these measures;
(II) The operating enterprise dealing with the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices fails to establish and execute sales record system according to the provisions of these measures.
Chapter VI Supplementary Provisions
Article 62 The following terms referred in these measures shall have the following meanings:
Medical device operation refers to the behavior of providing medical device products by the way of buying and selling, including procurement, acceptance, storage, sales, transportation, after-sales service, etc.
Medical device wholesale refers to the medical device operation behavior of selling medical devices to the operating enterprise or user unit with qualification.
Medical device retail refers to the medical device operation behavior of directly selling medical devices to consumers.
Article 63 The management provisions on Internet-based medical device operation shall be formulated by China Food and Drug Administration separately.
Article 64 The formats of the License for Medical Device Operation and the filing certificate for medical device operation shall be uniformly formulated by China Food and Drug Administration.
The License for Medical Device Operation and the filing certificate of medical device operation shall be printed and produced by the food and drug administration department of the municipality with districts.
The arrangement mode of the number of the License for Medical Device Operation is: XX Food and Drug Operation License No.XXXXXXXX. In which,
The first X indicates the abbreviation of the province, autonomous region or municipality directly under the central government where the licensed department is located;
The second X indicates the abbreviation of the municipal administrative region with districts;
The third X to the sixth X represent the four-digit licensing year;
The seventh X to the tenth X represent the four-digit licensing serial number.
The arrangement mode of the filing number of the filing certificate of Class II medical device operation shall be: XX Food and Drug Operation Filing No. XXXXXXXX.
In which,
The first X indicates the abbreviation of the province, autonomous region or municipality directly under the central government where the filing department is located;
The second X indicates the abbreviation of the municipal administrative region with districts;
The third X to the sixth X represent the four-digit filing year;
The seventh X to the tenth X represent the four-digit filing serial number.
Article 65 The business scope specified in the License for Medical Device Operation and the medical device operation filing certificate shall be determined according to the management category,classification and coding, and name of medical device. The management category, classification and coding, and name of medical device shall be verified according to the classified catalog of medical devices promulgated by China Food and Drug Administration.
Article 66 These measures should put in force from October 1, 2014. The Measures for the Management of the License for Medical Device Operating Enterprises promulgated on August 9, 2004 (the former State Food and Drug Administration decree No.15) shall be repealed simultaneously.
本文来源：https://www.2haoxitong.net/k/doc/9c3114c88662caaedd3383c4bb4cf7ec4bfeb659.html
文档为doc格式