I. Judgment questions: ( )1, where the operation of the second class, the third class of medical devices, should hold a "medical device business enterprise license". ( )2, medical device business enterprises for illegal operation has been (food) drug supervision and management department to investigate, but has not yet been closed; or has received the decision on administrative penalties, but has not yet fulfilled the penalties, provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should terminate the acceptance or review of its "medical device business Enterprise License" permit matters change application until the case is completed. ( )3. The enterprise shall reapply for the "Medical Device Business License" if it splits, merges or moves across the original jurisdiction. ( )4. "Medical Device Business License" is valid for 6 years. ( )5, the law is invalidated, recovered "medical device business enterprise license" provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department shall establish a file to be kept for 5 years. Second, single choice questions: 1, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments should be accepted within ( ) working days from the date of whether or not to issue "medical device business license" decision. A, 10 B, 15 C, 20 D, 30 2, provincial (food) drug supervision and management department shall make the decision to issue "medical device business enterprise license" within ( ) days from the date of issuance of "medical device business enterprise license" issued to the applicant. A. 5 B. 7 C. 10 D. 15 3. Where an application for a Medical Device Business License directly involves a ( ) relationship between the applicant and another person, the (food) drug supervision and management department shall inform the applicant and the interested party of the right to apply for a hearing in accordance with the law. A, significant interests B, economic interests C, business interests D, commercial secrets 4, (food) drug supervision and management department that the "Medical Device Business License" involves ( ), should be announced to the community, and hold a hearing. A, economic interests B, public **** interests C, business interests D, commercial interests 5, medical device business enterprises to apply for changes in licensing matters, provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should be accepted in the acceptance of the medical device business enterprise license matters within ( ) working days from the date of the application for changes in medical device business in accordance with the acceptance criteria for the inspection of enterprises to review. Enterprise inspection and acceptance standards for audit, and by the province, autonomous region, municipality directly under the Central (food) drug supervision and management department to make a decision to allow changes or not allowed to change; need for on-site inspection and acceptance should be accepted within ( ) working days from the date of the decision to allow changes or not allowed to change. A, 15; 20 B, 15; 15 C, 20; 20 D, 15; 30 6, medical device business enterprises to change the "medical device business enterprise license" registration matters, should be approved by the administrative department for industry and commerce after the change ( ) days to fill out the "Medical Device Business Enterprise License" application for change to the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or to accept the entrusted Municipal (food) drug supervision and management agencies to apply for "medical device business enterprise license" change registration. a. 15 b. 20 c. 30 d. 45 7, the expiration of the validity period, the need to continue to operate medical device products, medical device business enterprises should be in the validity of the expiration of the expiration date ( ), to the provincial, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal ( food) drug supervision and management departments or to accept entrusted to the district ( food) drug clinical supervision and management. (Food) drug pro- supervisory management [structure to apply for reissue of "medical device business license". A, 3 months B, 4 months C, 6 months D, 30 days three, multiple choice questions: 1, apply for "medical device business enterprise license" should also have ( ) conditions. A, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles B, with the scale and scope of operation of relatively independent business premises; appropriate storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical devices C, should establish and improve product quality management system, including purchasing, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system for adverse events. D, should have its operation of medical equipment products with appropriate technical training and after-sales service capabilities, or agreed by the third party to provide technical support 2, for the applicant put forward the "Medical Device Business License" licensing application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management departments or to accept the entrusted municipal (food) drug supervision and management agencies should be based on ( ) situation, the applicant should be in accordance with the "Medical Device Business License" application, the provincial, autonomous regions, municipalities directly under the central government (food) drug supervision and management department or to receive commissioned (food) drug supervision and management agencies. Institutions should be dealt with according to ( ) respectively. A, the application does not belong to the department's terms of reference, shall immediately make a decision of inadmissibility, issued a "notice of inadmissibility", and inform the applicant to apply to the relevant departments B, (b) the application materials can be corrected on the spot there is an error, the applicant should be allowed to correct the on-the-spot C, (c) the application materials are incomplete or do not comply with the statutory form, should be on the spot or within five working days to the applicant to issue a "notice of corrective materials". Issue a "Notice of Corrective Material", a one-time notification of all the contents that need to be corrected. If no notification is made after the deadline, the application shall be accepted from the date of receipt of the application materials. D. If the application falls within the scope of authority of the department, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials in accordance with the requirements, a Notice of Acceptance shall be issued. Acceptance Notice" should be stamped with the acceptance of the special seal and indicate the date of acceptance 3, "Medical Device Business License" license changes include ( ) changes. A, quality management personnel B, registered address C, business scope D, warehouse address 4, change the quality management personnel, should be submitted at the same time the new quality management personnel ( ) copies. A, identity card B, academic certificate C, title certificate D, enterprise change decision 5, change the registered address of the enterprise, should be submitted at the same time after the change of address ( ). A, a copy of proof of property rights B, a copy of the lease agreement C, geographic location map, floor plan D, storage conditions 6, change the address of the warehouse, should be submitted at the same time after the change of the warehouse address ( ). A, a copy of proof of property rights B, a copy of the lease agreement C, geographic location map, floor plan D, storage conditions description 7, medical device business enterprises have ( ) circumstances, (food) drug supervision and management department must carry out on-site inspections.A, the previous year's new start-ups; B, the previous year's inspection of the problematic enterprises; C, due to violations of relevant laws and regulations, the enterprises subject to administrative penalties; D, (Food) drug supervision and management department that need to carry out on-site inspection of other enterprises. 8, there ( ) circumstances, "Medical Device Business Enterprise License" by the original licensing authority cancellation. A, "Medical Device Business Enterprise License" expires without applying for or end of the permit to renew the license; B, medical device business enterprises to terminate the operation of the business or closed down in accordance with the law; C, "Medical Device Business Enterprise License" was revoked, withdrawn, revoked, withdrawn or declared invalid; D, force majeure causes medical equipment business enterprises can not operate normally; Fourth, fill in the blanks: 1, medical equipment business enterprises without authorization to expand the scope of business, reduce the operating conditions, by the (food) drug supervision and management department ordered to be notified of the criticism and impose a fine of 10,000 yuan more than 20,000 yuan. 2, the applicant conceals the relevant information or provide The applicant conceals the relevant information or provide false materials to apply for "medical device business license", the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies not to apply for or not to "medical device business license", and give a warning. The applicant shall not re-apply for the "Medical Device Business Enterprise License" within one year. 3, the applicant by deception, bribery and other improper means to obtain the "Medical Device Business Enterprise License", (food) drug supervision and management department shall its "Medical Device Business Enterprise License", give a warning and impose a fine of 10,000 yuan or more than 10,000 yuan or less. The applicant shall not apply again for the Medical Device Business License within one year. Answer Supplement
Sent in error, this is the "medical device business license management approach test questions" medical device instructions, labels and packaging marking regulations (State Council Decree No. 10) online training test questions