VII.     FLOWCHART LICENSE TO OPERATE
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Reviews the documents as to compliance with the requirements and submits report PowerPoint PPT Presentation


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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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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

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


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

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


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

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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