Transcript Slide 1

VII.
FLOWCHART LICENSE TO OPERATE
Medical Device Establishment
Responsible
Person
Start
Turnaround
(per day)
Time
Required
To do the Job
Applicant pays at the Cashier and Return the
Order of Payment at the BHDT
Applicant
Submits Application At BHDT
Receives application and assigns control
number
Evaluator
Assess the documents as to completeness
and verified against the e-copy
Evaluator
Documents
Complete and the same
as e-copy
N
Y
Disapproved
Application
and return
to applicant
Reviews the application and assigns task
of technical evaluation and inspection
Reviews the documents as to compliance
with the requirements and submits report
Reviews the Evaluation Report
Requirements
Complied?
N
Day 1
Day 2 - 6
Max 30 min
Evaluator
Division Chief
Day 3
Evaluator
Day 8-15
Division Chief
15 minutes
Max 60 min
Max 30 min
A
Y
For
Inspection?
Y
B
N
C
Prepares the License to Operate (LTO)
Initial and recommends approval of the
LTO
Approves the LTO
Release approved LTO
End
15 minutes
Evaluator
Division Chief
Director
Clerk
Day 16-20
15 minutes
Responsible
Person
Turnaround
(per day)
Time
Required
To do the Job
A
Prepares the Notice of Deficiency
Evaluator
Approves the Notice of Deficiency
Division Chief
15 min
Day 16-18-A
Clerk
Mail/Fax the Notice of Deficiency
5 min
15 min
End
B
Prepares Department Personnel
Order
Clerk
Conducts Inspection
Prepares and Submits Inspection Report
Reviews the Inspection Report
Requirements
Complied?
Y
C
N
D
Day 16-B
15 min
Inspector
Day 17-72-B
Inspector
Day 73-80-B
30 minutes
Division Chief
and Director
Day 81-B
30 minutes
240 min
Turnaround
(per day)
Time
Required
To do the Job
D
Submits Compliance to Deficiencies
Requirements
Complied?
N
Applicant
60 days
compliance
period
A
Y
Prepares the License to Operate
(LTO)
15 min
Inspector
5 days
Initial and recommends approval of the
LTO
Approves the LTO
Release approved LTO
End
Division Chief
Director
Clerk
15 min