Transcript Slide 1

VI. FLOWCHART CERTIFICATE OF PRODUCT REGISTRATION
Medical Device Products
PROCESS
Start
Responsible
Person
Turnaround
(per day)
Applicant
Day 1
Time
Required
To do the Job
Applicant Pays at the Cashier and Return
the Order of Payment at the BHDT
Submits Application At BHDT
Receives application and assigns control
number
Evaluator
Assess the documents as to completeness and
verified against the e-copy
Day 2-30
Documents
Complete and the
same as e-copy?
N
Y
Disapproved
Application
and return
to applicant
Evaluator
Does preliminary evaluation and assigns
task of technical evaluation
Division Chief
Review the documents as to compliance
with the requirements
Evaluator
Prepares Evaluation Report
Evaluator
Reviews the Evaluation Report
Requirements
Complied?
Max 120 min
Day 30-160
60-240 min
Division Chief
Day 161
30 minutes
Evaluator/Clerk
Day 162-170
15 minutes
N
A
Y
Prepares the Certificate of Product
Registration
Initial and recommends approval of the
CPR
Approves the CPR
Types CPR Number/Records/Releases
CPR
End
Division Chief
Day 171-172
Director
Clerk
15 minutes
Day 173
Day 174-180
15 minutes
Responsible
Person
A
Prepares the Notice of Deficiency
Division Chief
Mail/Fax the Notice of Deficiency
15 minutes
Day 162A-163A
5 minutes
Clerk
Applicant
Submits Compliance to Deficiencies
Evaluator
Evaluates the compliance documents
N
Time
Required
To do the Job
Evaluator
Approves the Notice of Deficiency
Requirements
Complied?
Turnaround
(per day)
15 minutes
Given 90 days
to comply the first NOD
another 60 days for
re-application (2nd NOD)
then if not
complied final
disapproval
Day 164A – 165A
30-60 minutes
A
Y
Prepares the Certificate of Product
Registration
Evaluator
15 minutes
Day 166A-172A
Initial and recommends approval of the
CPR
Approves the CPR
Types CPR Number/Records/Releases
CPR
Division Chief
Director
30 minutes
Day 173A
Clerk
Day 174A-180A
End
Note: those with “A” connotes that there are deficiencies in the submitted documents
15 minutes