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).