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

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

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