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Reviews the documents as to compliance with the requirements and submits report

VII. FLOWCHART LICENSE TO OPERATE Medical Device Establishment. Time Required To do the Job. Responsible Person. Turnaround (per day). Start. Applicant pays at the Cashier and Return the Order of Payment at the BHDT. Applicant. Day 1. Submits Application At BHDT.

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Reviews the documents as to compliance with the requirements and submits report

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  1. VII. FLOWCHART LICENSE TO OPERATE Medical Device Establishment Time Required To do the Job Responsible Person Turnaround (per day) Start Applicant pays at the Cashier and Return the Order of Payment at the BHDT Applicant Day 1 Submits Application At BHDT Receives application and assigns control number Evaluator Assess the documents as to completeness and verified against the e-copy Evaluator Day 2 - 6 Disapproved Application and return to applicant N Documents Complete and the same as e-copy Max 30 min Evaluator Y Reviews the application and assigns task of technical evaluation and inspection Division Chief 15 minutes Day 3 Reviews the documents as to compliance with the requirements and submits report Evaluator Max 60 min Day 8-15 Reviews the Evaluation Report Division Chief Max 30 min N Requirements Complied? A Y Y For Inspection? B N 15 minutes Prepares the License to Operate (LTO) Evaluator C Day 16-20 Division Chief Initial and recommends approval of the LTO 15 minutes Director Approves the LTO Clerk Release approved LTO End

  2. A B C Time Required To do the Job Responsible Person Turnaround (per day) Prepares the Notice of Deficiency Evaluator 15 min Day 16-18-A Approves the Notice of Deficiency Division Chief 5 min Clerk 15 min Mail/Fax the Notice of Deficiency End Prepares Department Personnel Order Clerk Day 16-B 15 min Conducts Inspection Inspector Day 17-72-B 240 min Inspector Day 73-80-B 30 minutes Prepares and Submits Inspection Report Division Chief and Director Day 81-B 30 minutes Reviews the Inspection Report N Requirements Complied? D Y

  3. D Time Required To do the Job Turnaround (per day) Submits Compliance to Deficiencies 60 days compliance period Applicant N Requirements Complied? A Y Prepares the License to Operate (LTO) 15 min Inspector 5 days Division Chief Initial and recommends approval of the LTO 15 min Director Approves the LTO Release approved LTO Clerk End

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