Comparison Chart of Annex III of Article 22 in the Regulations for the Inspection and 
Examination of Imported Medicaments before and after the Amendment 
Annex III 
1. Examination fee  The examination fee shall be calculated and collected at the following rates based 
on the duty-paid price:  
The examination rate for imported traditional Chinese medicinal materials is 1.5 ‰. If 
the examination fee is less than TWD200, it will be charged at TWD200 per case. If the 
amount exceeds TWD100,000, the exceeding amount will be charged by half. 
The examination rate for imported drugs is 2.5 ‰. If the examination fee is less 
than TWD500, it will be charged at TWD500 per case. If the amount exceeds 
TWD100,000, the exceeding amount will be charged by half. Active pharmaceutical 
ingredients are exempted from examination fee charges.  
The examination rate for imported medical equipment is 2.5 ‰. If the examination fee 
is less than TWD500, it will be charged at TWD500 per case. If the amount exceeds 
TWD100,000, the exceeding amount will be charged by half.  
2.On-site examination fee  According to the "Office Calendar of Government Administrative Offices" the 
service hours are from 8:30 am to 5:30pm during the work days of the week, 
and the charge will be TWD500 per site visit for each person. In case the 
services are required beyond the above-mentioned time period, additional fees 
shall be charged in accordance with the following provisions:  
TWD400 per person each time on work days from 6:00 am to 8:30 am or 5:30 
pm to 10:00 pm.  
TWD1,000 per person each time on off days from 6:00 a.m. to 10:00 p.m.  
TWD2,000 per person each time for services required beyond the time specified 
in the first two provisions.  
In case an accommodation arrangement is required due to the actual status that 
the personnel who provide such services are unable to return on the same day, an 
extra fee shall be charged according to the Directions of the Domestic Travel 
Allowance Disbursement of the Executive Yuan.  
Active pharmaceutical ingredients are exempted from on-site inspection fee.  
3. Notification Fee  A fee of TWD100 per copy for the re -issuance, renewal, additional copy of the 
drug import permit notification or registration content alteration.  
4. Inspection fee  The inspection fees shall be charged for the re-inspections of imported drugs, or 
the consequent inspections due to failure of sampling inspections.  
No. Test items  Description  Charge amount  Traditional Chinese medicinal materials  Fees shall be charged based on the 
"Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs, and Cosmetics". 
 A005 Heavy metals  Counted by each item and tested 
by colorimetry  
E011 HG  
E012 Arsenic   
E013 Lead   
E014 Copper   
E015 Cadmium    
E016 Organochlorine    
 
E017 Aflatoxin  
B1, B2, 
G1, G2   
Medical equipment   
 
A001 Ordinary inspection  
(Appearance of condom)  Visual defects (serious and 
non-serious)   
B006 Pinhole test of condom  According to CNS6629   
B012 Differential pressure test of surgical mask According to CNS14774  
B015 Submicron filtration efficiency  According to CNS14774 or 
CNS14755   
As detailed in the column of 
“Charge amount” Bacterial filtration efficiency of General medical  
mask According to CNS14774  Fees shall be charged based on the 
"Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs, and Cosmetics". 
The charging standard of the test item "  
Bacterial filtration efficiency of General 
medical mask " is based on "No. B011: 
Bacterial filtration efficiency of surgical masks”. 
As detailed in the column of 
“Charge amount” Differential pressure test of General medical 
mask According to CNS14774  Fees shall be charged based on the 
"Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs, and Cosmetics". 
The charging standard of the test item "  
Differential pressure test of General medical 
mask " is based on "No. B012: Differential 
pressure test of surgical mask”.  
As detailed in the column of 
“Charge amount” Breathing air resistance According to CNS14755 Fees shall be charged based on the 
"Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs, and Cosmetics". 
The charging standard of the test item 
"Breathing air resistance" is based on "No. 
B015: Submicron filtration efficiency”. 
API  
A002 Identification  Measured by one component or 
one method  Fees shall be charged based on the 
"Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs, and Cosmetics". 
Note: All charges shall be in TWD, and foreign currencies shall be converted into TWD according to the ten -day exchange rate table applicable to customs 
issued by the Customs Administration, Ministry of Finance.