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

DocumentsComplete 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 OPERATEMedical Device Establishment

ResponsiblePerson

Turnaround(per day)

TimeRequired

To do the Job

Applicant

Evaluator

Evaluator

Evaluator

Evaluator

Division Chief

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

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

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?

DN

Reviews the Inspection Report

C

Y

ResponsiblePerson

Turnaround(per day)

Evaluator

Clerk

Division Chief

Division Chief and Director

Day 16-B

Day 73-80-B

Day 81-B

15 min

15 min

30 minutes

30 minutes

Clerk

Day 16-18-A 5 min

15 min

Inspector

Inspector

TimeRequired

To do the Job

Day 17-72-B 240 min

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

15 minDivision Chief

TimeRequired

To do the Job

Applicant

Clerk

60 days complianceperiod

5 days

Approves the LTO Director