Regulations for Systematic Inspection  of Imported Food  
Promulgated  on February 11,  2014 
Amended o n October  17, 2014  
Amended on August 4 , 201 7 
 
Article 1  These Regulations are established in accordance with  the provisions of  
Paragraph 2 of  Article 35 of the Act Governing Food Safety and 
Sanitation  (hereinafter  referred to as  “Act”).  
Article 2  The terms used in these Regulations are defined as follows:  
1. “Systematic inspection ” means  inspecting the  food safety 
management  system  and the supervisory measures taken by the 
government s of the exporting country (territory).  
2. “Inspection  authority” means  the Food and Drug Administration, 
Ministry of Health and Welfare.  
3. “Document  review”  means  reviewing  the documentation relating  to 
the food safety management  system in the exporting country (territory) 
provided by the governmental  authority of the exporting country 
(territory).  
4. “On-site inspection ” means  the inspection authority  designates 
inspect ors to conduct the systematic inspection of the food safety 
management system in the exporting country (territory) . 
Article 3  The scope of products subject to systematic  inspection  is outlined  in the 
attachment.  
Article 4  To perform systematic inspection, the exporting country (territory) shall 
apply to the inspection authority with documents  for approval of import 
of the product des cribed in the above paragraph. Inspection authority 
shall conduct the document s review. If required, on -site inspection can be 
conducted following t he document review.  Only if the food safety 
management  system of the exporting country (territory) is determined as 
equivalent based on the systematic inspection, the application of the 
exporting country (territory) will be approved.  If necessary, Inspection authority shall request the exporting country 
(territory)  (territory) to provide the documents within the designated 
period  when performing the pre -said document review.  
Product s which are subject to the scope of this regulation, are not 
conforming to the  paragraph 1of this Article  shall not be applied for 
inspection unless are exempt according to Article 7 . 
Article 5  For any exporting country (territory) that has been systema tically 
inspected  and been approved to import or that is exempted  from 
systematic inspection  in accordance with the provisions of Article 7, in 
case of any of the following, the inspection authority  may request  
document  review or  on-site inspection  to confirm the equivalence of the 
management system  of the exporting country (territory).  
1. Significant change s of food safety management  system  or the 
supervisory measures of the exporting country (territory).  
2. Occurrence of significant food sanitation and safety incident s in the 
exporting country  (territory) . 
3. Significant violation of the f ood or related product from the exporting 
country (territory)  found by the inspection authority  or other 
importing country (territory) . 
4. Any exporting country (territory) that is exempted from systematic 
inspection in accordance with the provisions of Article 7 or that has 
been finished systematically inspected more than three years, deemed 
necessary to conduct documents review  or on-site i nspection by the 
inspection authority.  
5. Food or related product s which from the exporting country (territory) 
were determined as jeopardizing food safety.  
Article 6  If the results of  on-site inspection  are non-compliant, the exporting 
country  (territory)  may be required to submit  corrective action s, to the  
inspection  authori ty for review before deadline. If required, on-site 
inspection  might be performed again to  verify the effectiveness of the corrective action s and on-site inspection cost shall be borne by  the 
exporting country  (territory) . 
Article 7  Product s, subjected to the scope of this regulation, had existed import 
records before promu lgation of these Regulation might be  exempted from 
the systematic inspection .  
Article 8  These Regulations shall be  implemented from the d ate of promulgation . 
The article of the Regulation amended on August 4, 2017  except the 
fishery and dairy products implemented on January 1, 2018 , shall be 
implemented from the date of promulgation.  
 
 
 
 
Attachment Scope of Prod ucts Subject to Systematic Inspection  
Type  Item Remarks  
Meat 
Products  Products listed in 02, 050 4, 1601 and 1602 
of the Harmoni zed System Codes (HS 
Codes) established by the World Customs 
Organization.  1. Products on the left 
column  subject to 
importation rules 
F01 or F02.  
2. Products from 
amphibians, reptiles, 
primat es, aquatic 
mammals are not 
subject to systematic 
inspection.  
Fishery  
Products  Products listed in 0 3, 1604 and 1605  of the 
Harmoni zed System Codes (HS Codes) 
established by the World Customs 
Organization.  1. Products on the left 
column subject to 
importation rules 
F01 or F02.  
2. These products come 
into enforcement 
from  January 1, 2018 . 
Dairy 
Products  Products listed in 0 401, 0402, 0403, 0404 , 
0405,  0406 and 9806  of the Harmoni zed 
System Codes (HS Codes) established by 
the World Customs Organization.  1. Products on the left 
column subject to 
importation rules 
F01 or F02.  
2. These products come 
into enforcement 
from  January 1 , 
2018. 
Products 
of bovine 
origin  Bovine derivatives food products, not 
classified as meat products, from BSE 
infected countries.  Products on the left 
column belong to  
following foods are 
exempted:  
(1) Tallow and its 
derivatives without 
protein； 
(2) Calcium hydrogen 
phosphate without 
protein； 
(3) Bovine hide ； 
(4) Gelatin and 
collagen from 
bovine hide ； 
(5) Bovine deriv ed 
products  from non - 
BSE-infected 
countries  or the 
BSE 
infected -countr y 
has been completed 
the systematic inspection  with 
certificate of origin 
of the material and 
sanitation (health) 
certificate of the 
product.