Measures for the Supervision and Management of Medical Device Operation
Chapter I General Principles
Article 1The 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 the measures.
Article 3China 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.
提升记忆力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 4Classified 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 5China Food and Drug Administration shall formulate the good supply practice for medical devices and supervi 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
求生装备Article 7 Applicant dealing with medical device operation should meet the following conditions:
(I) Posss the quality management institution or quality management personnel appropriate to the o
perating 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) Posss the operating and storage site appropriate to the operating scale and business scope;
(III) Posss the storage conditions appropriate to the operating scale and business scope.Storeroom may not be t up in ca of the storage fully entrusted to other medical device operating enterpri;
(IV) Posss the quality management system appropriate to the medical devices operated;
window截图(V) Posss the capability of professional guidance, technical training and after-sales rvice appropriate to the medical devices operated, or provide technical support by relevant institution as agreed.
The enterpris 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 enterpris 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 enterpri 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 licen and organization code certificate;
(II) Copies of the ID cards, educational background or professional title certificates of legal reprentative, responsible person of enterpri, 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 hou ownership certificate leasing agreement (attached with hou 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;
红色主题诗词(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 sho
竞买保证金uld immediately make the decision on denial to accept the application and inform the applicant to submit application to relevant administrative department.
In ca 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 ca of rectification required, the rectification time will not be included in the examination and verification time.读书笔记的格式
For tho meeting specified conditions, the written decision on licensing shall be made according to laws and the Licen for Medical Device Operation shall be issued within ten (10) working days; for tho not meeting specified conditions, if the written decision on denial is made, the reasons should be specified.
Article 11If the application for the licensing of medical device operation directly relates to the major in
terest 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 ca of the operation of Class II medical devices, operating enterpri 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 the measures (except for Item 8).
Article 13 Food and drug administration department should verify the integrity of the materials submitted by enterpri on the spot; filing will be permitted for tho complying with the provisions and issued with the certificate of filing for the operation of Class II medical devices.
Article 14The food and drug administration department of the municipality with districts should carry out the on-the-spot verification on the operating enterpri of Class II medical device according to th
e requirements of the Good Supply Practice for medical devices within 3 months from the filing date of the medical device operating enterpri.
Article 15 The valid period of the Licen for Medical Device Operation is five (5) years, which shall indicate such items as licen number, name of enterpri, legal reprentative, responsible person of enterpri, residence, site of business operation,mode of operation, business scope, address of warehou, issuing body, issuing date, valid period, etc.
The certificate of filing for medical device operation should indicate such items as the number, name of enterpri,legal reprentative, responsible person of enterpri, residence, site of business operation, mode of operation, business scope, address of warehou, filing department, filing date, etc.
Article 16The change of the items in the Licen 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 warehou.
Change of registration items includes other items beyond aforesaid items.高可儿
Article 17 In ca of change of licensing items, the application for change of the Licen 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 the measures should be submitted.
If warehou is arranged across administrative regions, applicant should handle the filing with the food and drug administration department of the municipality with districts where the warehou 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 ca 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 Licen for Medical Device Operation shall remain unchanged.
Article 18For new independent site of business operation, medical device operation licensing or filing should be applied independently.
Article 19 In ca of change of registration items, medical device operating enterpri 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 enterpri existed due to splitting and merger should apply for change of licensing according to the provisions of the measures; the medical device operating enterpri dissolved due to splitting and merger should apply for cancellation of the Licen for Medical Device Operation; and the medical device operating enterpri newly established due to splitting and merger should apply for handling the Licen for Medical Device Operation.
我的感动Article 21Medical device registrant,filer or manufacturing enterpri lling medical devices at their residences or manufacturing site may not handle operation licensing or filing; in ca of storing at other places and lling medical devices on the spot, they should handle the operation licensing or filing according to provisions.
Article 22 If the valid period of the Licen for Medical Device Operation is extended upon expiration, medical device operating enterpri should submit the application for the extension of the Licen 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 the 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 Licen for Medical Device Operation. If the application for extension that meets the specified conditions is approved,the number of the extended Licen for Medical Device Operation shall remain unchanged. Tho 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 23In ca of any change to the filing items such as the name of enterpri, legal reprentative, responsible person of enterpri, residence,site of business operation, mode of operation, business scope, address of warehou, etc. in the filing certificate of medical device operation, the filing should be changed in a timely manner.
Article 24 In ca that the Licen for Medical Device Operation is lost, medical device operating enterpri 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-issuan
ce of the certificate shall be submitted to the original issuing department. The original issuing department should timely re-issue the Licen for Medical Device Operation.
