Regulations for Systematic In spection of Imported Food  
Established in February 11, 2014 
 
Article 1 These Regulations are established in acco rdance with the provisions of Paragraph 2 of 
Article 35 of the Act Governing Food Safety and Sanitation (hereina fter 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 th e governments 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 expor ting country (territo ry) provided by the 
governmental authority of the exporting country (territory). 
4. “On-site inspection” means the inspec tion authority designates inspectors to 
conduct the systematic inspection in the exporting country (territory). 
Article 3 The range of products subject to system atic inspection is outlined in the attachment. 
Article 4 To perform systematic  inspection, the exporting country (territory) sha ll apply to the 
Inspection authority for approval of impor t of the product described in the above 
paragraph.  Inspection authority shall conduct the document review.  If required, 
on-site inspection can be conducted following the document review.  Only if the food 
safety management system of the exporti ng country (territory) is determined as 
equivalent based on the systematic inspecti on, the application of the exporting country 
(territory) will be approved. 
Article 5 The inspection authority may request the exporting country (t erritory) to provide 
documents within the designated period as required by the document review. 
For any exporting country (territory) that ha s been systematically inspected and been 
approved to import or that is exempted fr om systematic inspection in accordance with 
the provisions of Article 7, in case of a ny of the following, the inspection authority 
may initiate document review or on-site inspection to confirm the effectiveness of the management system of the exporting country (territory). 
1. Significant changes of food safety mana gement system of the exporting country 
(territory). 
2. Occurrence of significant f ood sanitation and safety incidents in the exporting 
country (territory). 
3. Occurrence of significant vi olation while conducting the import inspection of the 
food or related product from the exporti ng country (territory) by the inspection 
authority of importing country (territory). 4. Other circumstances considered the f ood or related product of exporting country 
(territory) may have food safety risk. 
Article 6 If the results of on-s ite inspection are non-compliant, th e exporting coun try (territory) 
may be required to submit co rrective actions, to the inspection authority for review 
before deadline.  If required, on-site insp ection might be performed again to verify 
the effectiveness of the correc tive actions and on-site inspec tion cost shall be borne by 
the exporting country (territory). 
Article 7 For any product subject to systematic  inspection under these Re gulations, if there is 
already existing records of importation before being included within the range of 
products subject to systematic inspecti on under these Regulations, the inspection 
authority may be exempted from application for systematic inspection within the 
scope of prior importation before th e publication of th ese Regulations.. 
Article 8 These Regulations are impleme nted from the date of publication. 
 
 
Attachment    Range of Products Subject to Systematic Audit 
 
Type Item Remarks 
Meat 
Products Under the Harmonized Commodity Description and Coding System developed and maintained by the World Customs Organization, the products covered by Harmonised System Codes (HS Codes) chapte2, and heading 0504, 1601, 1602 and 1603. Among the categories of imported products on the left column, those with importation rules F01 or F02.