Professional Documents
Culture Documents
I. Importation: Product Category Product Description or Form Requirements For Release
I. Importation: Product Category Product Description or Form Requirements For Release
I. Importation: Product Category Product Description or Form Requirements For Release
Department of Health
FOOD AND DRUG ADMINISTRATION
I. IMPORTATION
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION
OR FORM
Valid
CPR
Yes
No
A. DRUGS
LTO as
DM or as
DT
No
LTO as DI
No
NN
E-Reg
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION OR
FORM
Valid
CPR
a. Finished product
LTO as FI
Yes
LTO as
FM/I or as
FT/I
No
LTO as FI
Yes
d. Finished product
for packing
LTO as
FT/I
Valid NN
E-Reg
(Low
Risk)
B. Processed
Food
Yes
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION OR
FORM
Valid
CPR
B. Processed
Food
Under FFL
Wheat Flour,
Cooking Oil,
Sugar
LTO as FI
Yes
Under ASIN
Iodized Salt
LTO as FI
Yes
Valid NN
E-Reg
(Low
Risk)
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION OR
FORM
a. Finished product
LTO as CI
Yes
HUHS
a. Finished product
LTO as
HUHS/I
Yes
Pesticides
a. Finished product
LTO as
HUHS/I
Yes
b. Raw mats
LTO as
HUHS/I
Yes
a. Finished product
LTO as
HUHS/I
Valid
CPR
Valid NN
C. Cosmetics
Toys below
14 years old
Yes
E-Reg
(Low
Risk)
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION OR
FORM
Valid
CPR
D. Medical
Devices
a. Finished product
Radiation
Emitting
Device
Health-related
Device
LTO as
MDI
Yes
Certificate
for
Customs
Release
(CFCR)
Water Filtration
Purification Device
Hospital waste
Disinfection Device
Yes
Valid NN
E-Reg
(Low
Risk)
II. EXPORTATION
PRODUCT
CATEGORY
PRODUCT
DESCRIPTION OR
FORM
Valid
CPR
DRUGS
LTO as
Exporter
Yes
Processed
Foods
LTO as
Exporter
Yes
Cosmetics
LTO as
Exporter
Medical
Devices
LTO as
Exporter
Valid NN
Yes
Yes or
COPE
E-Reg
(Low
Risk)
III. OTHERS
PURPOSE OF
IMPORTATION
REQUIREMENTS PRIOR TO
BOC RELEASE
Donation: Drugs
FDA Certification/Clearance
FDA Certification/Clearance
FDA Certification/Clearance
Research
FDA Certification/Clearance
Clinical Trials
Import Permit
FDA Certification/Clearance
(except Drugs)
FDA Certification/Clearance
Compassionate Use
Import Permit
Personal Use
REMARKS
Subject to FDA inspection
and collection of
representative samples for
ACPR
Subject to Inspection
THANK YOU!