Comparison Table for the Draft Amendment to 
Article 24 of Regulations for the Inspection and 
Examination of Imported Medicaments  
 
New Text Current Text  
Article  24 These regulations shall be 
implemented on the date of promulgation.  
      The amendment to Annex II of 
Article 22 promulgated on July 3rd, 2015 
shall be implemented from July 1st, 2015.  
The ame ndment to Annex II of 
Article 11 and Annex Ⅲ of Article 22  
promulgated on July O , 2020  shall be 
implemented from July O, 2020 . 
 Article  24 These regulations shall be 
implemented on the date of promulgation.  
      The amendment to Annex II of 
Article 22 promulgated on July 3rd, 2015 
shall be implemented from July 1st, 2015.  
 
 Item: Medical Mask  
Classification 
No. Classification 
Code  Product  
Name  1. Sampling inspection method and sampling rate:  
For medical masks of the same obligor, item, brand , and origin, the inspection shall start with three consecutive 
batches, and sampling inspection can b e conducted if the first three batches are successful. The qualified 
vendor  shall be subject to batch inspection by sampling one batch from 10 batches  in future deliver ies. If 
there is any failure found in the batch inspection, the batch inspection no longer be valid  and shall not be resumed 
until another three -consecutive -batch successes have been ac hieved. All the required inspections have to be 
performed on site.  
2. On-site inspection:  
Items to compare: manufacturer name and address.  
3. Inspection items:  
A random sample of 100 pcs per batch.  
The acceptable quality level (AQL) ratio is based on the standard of CNS 2779, and different items are tested 
according to the national standards of CNS 14774 medical face (mouth) mask and CNS 14755 disposable dust 
mask:  
General medical face (mouth) mask  
 
 
 
 
 
Surgical face (mouth) mask  
 
 
 
 
 
 
Surgical D2 dust mask  
 
 
 
 
 
 
 (The Bureau of 
Foreign Trade 
shall assist in 
the 
classification 
of medical 
masks)  I.4040  General 
medical face 
(mouth) 
mask; 
surgical face 
(mouth) 
mask; 
surgical D2 
dust mask  
Item Inspection level  Acceptable 
quality level  
Bacterial filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
Differential pressure  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
 
 
Project  Inspection level  Acceptable 
quality level  
Submicron filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
Differential pressure  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
 
Project  Inspection level  Acceptable 
quality level  
Submicron filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
Breathing air resistance  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 
 Annexed table 3  
1. Examination  fee The examination  fee shall be calculated and collected at the following rates based on the duty -paid price:  
1. The examination  rate for imported traditional Chinese medicinal materials is 1.5 ‰ . If the examination  fee is less than TWD 200, 
it will be charged at TWD 200 per case. If the amount exceeds TWD100,000, the exceeding amount  will be charged by half.  
2. 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 . 
3. 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:  
1. TWD400 per person each time  on work days from 6:00 am to 8:30 am or 5:30 pm to 10:00 pm.  
2. TWD1,000 per person each time on off days  from 6:00 a.m. to 10:00 p.m.  
3. 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 perso nnel who provide  such services 
are unable to return on the sa me 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, addit ional copy  of the drug import permit  notification or 
registration content alteration . 
4. Inspection fee  The inspection fee s shall be charged for the re -inspection s of imported drugs , or the  consequent inspections due to  failure 
of sampling  inspection s. 
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  Count ed by each item 
and test ed 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  
B011  Bacterial 
filtration 
efficiency of 
surgical 
masks  According to  
CNS14774  
B012  Differential 
pressure test 
of surgical 
mask  According to  
CNS14774  
B015  Submicron 
filtration 
efficiency  According to  
CNS14774  Being 
prepared 
by the 
research 
and 
inspection 
team  Breathing air 
resistance  According to  
CNS14755  
API 
A002  Identification  Measured 
by one 
component 
or one 
method  
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.