Amendments to Articles 4 and 19 of the Regulations Governing 
Border Inspection and Examination of Imported Medical 
Devices  
Article 4  In accordance with the provisions of Paragraph 1 of Article 52 of 
this Act, obligatory inspection applicants who apply to import 
medical devices referred in the preceding article shall file the 
completed application form for inspection and submit the 
follo wing documents and information to the inspection authority 
at the port where the medical devices are to be imported, 15 days 
prior to the date of inspection:  
1.  A photo copy of the medical device license or listing, or 
approval document to import the medic al devices as a special 
case.  
2.  A photo copy of application for import declaration.  
3.  Other documents and information designation by the central 
competent authority.  
 
If the application is to be filed by a representative, an 
identification document for the representative and a letter of power 
of attorney shall be provided unless the obligatory inspection 
applicant can provide a copy of the long -term entrustment 
agreement and has notified the inspection authority of the 
entrustment.  
 
The central competent  authority may require the obligatory 
inspection applicant to submit the application of the preceding 
paragraph electronically.  
 
In the event that the inspection authority discovers that the 
application documents and information are not complete but 
correc tions can be made, the inspection authority shall notify the 
obligatory inspection applicant who shall make corrections within 
20 days. In the event that the applicant fails to make corrections 
before the designated deadline, the application shall be rejec ted. 
 
Article 19  These R egulations shall be implemented on May 1st, 2021.  
The amendments to the Regulations shall take effect on the 
date of promulgation.   Attachment 1 of Article 3 of the Regulations 
Governing Border Inspection and Examination of 
Imported Medical Devices --List of amendments  
Attachment 1  
Item 
No. Item Name  Classification 
Code  Chinese Name  English Name  
1 4014.10.00.10  L.5300  Condom  Condom  
2 4014.10.00.90  L.5310  Condom with 
spermicidal 
lubricant  Condom with 
spermicidal lubricant  
3 6307.90.50.31 -A I.4040  General medical 
mask  General medical mask  
4 6307.90.50.31 -B I.4040  Surgical mask  Surgical mask  
5 6307.90.50.31 -C I.4040  N95 medical mask  N95 medical mask  
6 3002.15.00.10  B.4020  COVID -19 
Antigen 
Home/Self  Test COVID -19 Antigen 
Home/Self  Test  Attachment 2 of Article 6 of the Regulations 
Governing Border Inspection and Examination of 
Imported Medical Devices --List of Amendments  
Attachment 2: Verification items, test items and testing methods of imported medical 
devices.  
 
Attachment 1: Item No. 1: Condom; Item No. 2: Condom with spermicidal lubricant  
 
1. Verification item:  Name and address of the manufacturer (labeling shall be completed 
before importation; a letter from the original manufacturer shall be  
attached when the documents are not in English.)  
2. Test items and testing methods:  Randomly select 315 samples when the batch has 
500,000 (or less) units and 500 samples when the batch 
has 500,001 (or more) and perform the following 
examination:  
 
Test i tem Testing methods  
Appearance  In accordance with CNS 6629 T2008  
Pin-hole test  In accordance with CNS 6629 T2008  
 
   
Attachment 1: Item No. 3: General medical masks, Item No. 4: Surgical mask, Item No. 5: 
N95 medical mask  
 
1. Verification item:  Name and  address of the manufacturer (labeling shall be completed 
before importation; a letter from the original manufacturer shall be 
attached when the documents are not in English.)  
2. Test items and testing methods:  Randomly select 100 samples from each batch a nd 
perform the following examination:  
General medical mask  
Test item  Testing methods  
Bacterial filtration efficiency (BFE)  In accordance with CNS 14774  
Pressure difference  In accordance with CNS 14774  
Surgical mask  
Test item  Testing methods  
Sub-micron particulate filtration 
efficiency test  In accordance with CNS 14774  
Pressure difference  In accordance with CNS 14774  
N95 medical mask  
Test item  Testing methods  
Sub-micron particulate filtration 
efficiency test  In accordance with CNS 14755  
Respiratory impedance  In accordance with CNS 14755    
Attachment 1: Item No . 6: COVID -19 Antigen Home/Self Test 
 
1. Verification item:  Name and address of the manufacturer (labeling shall be 
completed before importation; a letter from the original manufacturer 
shall be attached when the documents are not in English.)  
2. Test items and testing methods:  Randomly select 100 samples from each batch and 
perform the following examination:  
 
Test item  Testing methods  
Analytical reactivity test of 
diagnostic reagent  Appropriate virus strains are used to confirm if the positive 
and negative result of the product is correct  
Detection limit of the diagnostic 
reagent  The claimed detection limit for positivity will be tested with 
appropriate viral concentration.