Regulations Governing Border Inspection and Examination of Imported 
Medical Devices 
Chapter I General Provisions 
Article 1.  The Regulations are stipulated in accordance with Paragraph 2, 
Article 52 of the Medical Devices Act (hereinafter referred to as 
"the Act").  
Article 2.  Terms used in the Regulations shall have the following 
meanings: 
1. Inspection: This refers to batch-by-batch verification or 
examination or random-selected batch verification or 
examination of imported medical device before permitting 
the importation.  
2. Verification: This refers to examination or verification of 
items, packaging, appearance, labels or other items of 
products carried out by inspectors in accordance with the 
law.  
3. Examination: This refers to conducting sensory, chemical, 
biological, or physical examination or tests in a laboratory.  
4. Inspection authorities: This refers to the central competent 
authority in charge of inspection of imported medical device 
or refers to the organization(s) appointed or commissioned 
by the central competent authority.  
5. Obligatory inspection applicants: This refers to importers of 
medical devices.  
Chapter II Application for Inspection of Imported Medical Device 
Article 3.  Provisions governing medical device items requiring border 
inspection by the central competent authority are listed in 
Attachment 1.  
 
Article 4.  In accordance with the provisions of Paragraph 1 of Article 52 of 
the 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 
following 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 photocopy of medical devices license or listing.  
2. A photocopy of application for import declaration.  
3. Other documents and information designated 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 
corrections 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 rejected.  
Article 5.  Imported medical devices conforming to one of the following 
situations can be exempted from inspection referred to the 
preceding article:  
1. Imported medical devices are for exclusive use as samples 
or for personal use only in accordance with the provisions of 
Subparagraph 4, Paragraph 1 of Article 35 of the Act.  
2. Imported medical devices are originally manufactured 
domestically and exported ,and they are shipped back to 
Taiwan with the approval of the central competent 
authority.  
3. Imported medical devices are issued with a certificate of 
examination by the government of the country of origin who 
has signed an examination waiver reciprocity agreement 
with the government of the Republic of China.  
4. The import has been approved by the central competent 
authority for national emergency situation or to improve the 
public welfare.  
Chapter III Inspection Procedures 
Article 6.  The inspection authority may proceed inspection with one or 
more of the following measures:  
1. Batch-by-batch inspection: Inspect each submitted batch 
of imported medical devices.  
2. Randomly selected batch examination: Randomly select 
each submitted batch of imported medical devices by 
following inspection rate, and inspect the chosen 
medical devices: 
(1) Regular randomly-selected batch inspection: The 
inspection is performed based on a 2-10% 
inspection rate.   (2) Reinforced randomly-selected batch inspection: The 
inspection is performed based on a 20-50% 
inspection rate.  
3. On-site inspection: Verify the products at the storage site 
of medical devices.  
Inspection items, test items and testing methods of imported 
medical devices as prescribed in Attachment 2.  
Article 7.  Imported medical device applied for inspection that belong to 
one of the following situations shall be inspected on a 
batch-by-batch basis:  
1. The first three batches of imported medical devices with the 
same item name, same trademark (brand name) and same 
origin imported by the obligatory inspection applicant.  
2. Reinforced random-selected batch was performed on the 
previous batch of imported medical devices of the same 
item name, same trademark (brand name) and same origin 
imported by the obligatory inspection applicant and the 
inspection result does not conform to regulations.  
3. The inspection authority determines that it is necessary to 
carry out the inspection on a batch-by-batch basis.  
Prior to the completion of the batch-by-batch inspection, the 
same obligatory inspection applicant applied for inspection of 
products shall be subject to inspection on a batch-by-batch basis.  
Article 8.  Imported medical device applied for inspection that belong to 
one of the following situations shall be inspected on a reinforced 
random-selected batch basis:  
1. Regular randomly-selected batch inspection is performed on 
the previous batch of imported medical devices of the same 
item name, same trademark (brand name) and same origin 
imported by the obligatory inspection applicant and the 
inspection result does not conform to the Regulations.  
2. The inspection authority determines that it is necessary to 
carry out reinforced batch-by-batch inspection.  
Article 9.  Imported medical device applied for inspection that belong to 
one of the following situations shall be inspected on a regular 
random-selected batch basis:  
1. The result of batch-by-batch inspection performed in 
accordance with Subparagraph 1, Paragraph 1 of Article 7 
of the Regulations is in conformity with the provisions.  
2. The inspection results of the previous five batches in a row 
in accordance with Subparagraph 2, Paragraph 1 of Article 7 
or preceding Article of the Regulations are in conformity 
with the provisions and the quantity of the five conforming  batches are three times of the quantity of non-conforming 
products.  
Article 10.  The samples required for inspection by the inspection authority 
shall be taken free-of-charge. The number (amount) of sampling 
shall be limited to requirements for examination.  
After collecting the samples, the inspection authority shall 
issue a receipt for sampling to the obligatory inspection 
applicant.  
Article 11.  Sampling for inspection shall be conducted at the storage site of 
medical devices.  
If the products were shipped in full container load, sampling 
shall be conducted in the centralized inspection area of port 
designated by the customs or designated area recognized by the 
inspection authority; but if it takes too long for sampling or has 
other difficult situations, the inspection authority may ask to 
open container for warehouse delivery.  
During the inspection in preceding paragraph, the obligatory 
inspection applicant shall cooperate accordingly and cannot 
appoint any specific sample.  
Article 12.  Examination of imported medical device shall be conducted in 
the order of sampling. However, the examination laboratory shall 
prioritize inspection on products applying for re-examination in 
accordance with Article 15 of the Regulations.  
Article 13.  For inspection of medical devices that are difficult to sample in a 
container yard, require five or more days for examination, 
perishable, or lack stability on safety efficacy, the inspection 
authority shall issue a Notice of Prior for Import for custom 
clearance after the obligatory inspection applicant declares to 
bear the responsibility for the safety and storage of products 
imported by signing an Affidavit.   
In the event that the pledged storage location of medical 
devices released for customs clearance with a Notice of Prior 
Release for Import in accordance with the preceding Paragraph 
does not conform to the actual storage location, or if the medical 
devices are put to use, are moved or sold before receiving the 
import permit, the inspection authority may temporarily suspend 
acceptance of an application for prior release of imports by the 
obligatory inspection applicant for a period of 1 year.  
Article 14.  In the event that imported medical device conforms to inspection,  
an import permit will be issued and the obligatory inspection 
applicant will be notified ; the obligatory inspection applicant 
may apply for the inspection authority to issue a written import 
permit.   The obligatory inspection applicant can claim remaining 
samples by presenting the sampling receipt within 15 days after 
receipt of the notice of inspection results. However, if the sample 
is not collected within the time period or has short shelf life, the 
inspection authority may dispose of the samples directly.  
Article 15.  In the event that imported medical device fails to conform to 
inspection, the inspection authority shall issue a notification of 
noncompliance to the obligatory inspection applicant.  
The obligatory inspection applicant can apply for 
re-examination to the original inspection authority within 15 days 
after receipt of the notification of results. However, applications 
for re-examination is limited to one time only.  
The inspection authority can perform the re-examination 
using remaining samples; if the remaining samples are not 
adequate for re-examination, additional sampling may be 
required according to Article 11 of the Regulations.  
For medical devices that do not conform to regulations upon 
inspection, as referred to in Paragraph 1, the remaining samples 
of products shall be destroyed after the end of the period of 
application for re-examination, unless otherwise stated by law.  
Article 16.  Imported medical devices that do not conform to provisions of 
inspection, unless otherwise stated by law, shall be shipped back 
or destroyed by the obligatory inspection applicant.  
If imported medical devices that have been released via a 
prior release notice do not conform to inspection , the inspection 
authority shall notify the obligatory inspection applicant to 
dispose the medical devices in accordance with the provisions of 
the preceding Paragraph and notify the municipality (county/city) 
competent authority.  
Chapter IV Statutory Fees 
Article 17.  The obligatory inspection applicant shall pay the following 
administrative charge for inspection performed in accordance 
with the Regulations:  
1. Review fees;  
2. On-site inspection fees;  
3. Notification fees;  
4. Fees for updating information from on-line application;  
5. Examination fees;  
The inspection fees in the preceding Paragraph is described 
in Attachment 3.  
Chapter V Supplementary Provisions  Article 18.  When conducting field inspections under the Regulations, 
inspectors shall carry and present certification documents related to the 
inspection operation or their credentials that show their identity.   
Article 19.  The Regulations shall be implemented on May 1st, 2021.  
 
   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 
   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 item 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 mask; 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 and 
perform the following examination: 
3.  
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 3 
 
Item Fees (in NTD) 
1. Review fees;  The review fees use duty-paying value (DPV) and are charged 
according to the following rates: 
Review fees of imported medical devices is 0.25%. When the 
review fees are less than 500 NTD, 500 NTD will be charged. 
When the review fees are over 100,000 NTD, the exceeding 
amount will be halved.   
2. On-site inspection 
fees; Inspectors work from 8:30 am to 5:30 pm on work days in 
accordance with the Official Work Calendar for Government 
Agencies. 500 NTD will be charged per location per inspector.   
Additional fees will be charged according to the following rates if 
inspections are to be performed outside aforementioned time. 
1. 400 NTD per person-time for 6 am to 8:30 am or 5:30 pm to 10 
pm on a work day.   
2. 1000 NTD per person-time for 6 am to 10 pm on a holiday.   
3. 2000 NTD will be charged per person-time for inspection 
outside the aforementioned time.   
If the inspector needs to stay overnight and requires 
accommodation, the fees for travel and accommodation will be 
charged in accordance with "The Standards for Reimbursement of 
Domestic Business Trip Expenses" stipulated by the Executive 
Yuan.  
3. Notificat ion fees; The fees for re-issuance, replacement, additional copy, or 
correction of the notification of import permit of imported medical 
device and notification of nonconformity.   
4. Fees for updating 
information from 
on-line application. If the obligatory inspection applicant or the representative applies 
for updating information from on-line application for reasons that 
the obligatory inspection applicant or the representative is 
responsible for, 100 NTD will be charged for each application. 
The fees include a copy of re-issued permit with notification 
stating the correction.   
4. Examination fees;  The fees required for re-inspection of imported medical device or 
the fees for batch-by-batch inspection when the product fails to 
conform with the regulation upon random-selected batch  inspection.   
Item Description Fee-charging items and amount 
Appearance of 
condom Visible defects 
(severe and not 
severe) Fees are charged in accordance with "A001: 
General test" of " Fee-Charging Standards for 
Lot Release, Reference Materials, and Testing 
of Foods, Drugs and Cosmetics".   
Condom pin-hole test  In accordance 
with CNS 6629 Fees are charged in accordance with "B006: 
condom pinhole test" of " Fee-Charging 
Standards for Lot Release, Reference 
Materials, and Testing of Foods, Drugs and 
Cosmetics".   
Surgical mask 
bacterial filtration 
efficiency In accordance 
with CNS14774  Fees are charged in accordance with "B011: 
Surgical mask bacterial filtration efficiency" of 
" Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs and Cosmetics".   
Surgical mask 
differential pressure 
test In accordance 
with CNS 14774  Fees are charged in accordance with "B012: 
Surgical mask differential pressure test" of " 
Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs and Cosmetics".   
Surgical mask 
differential pressure 
test In accordance 
with CNS 14774  Fees are charged in accordance with "B012: 
Surgical mask differential pressure test" of " 
Fee-Charging Standards for Lot Release, 
Reference Materials, and Testing of Foods, 
Drugs and Cosmetics".   
Sub-micron particulate 
filtration efficiency 
test In accordance 
with CNS 14774 
or CNS 14755 Fees are charged in accordance with "B015: 
Surgical masks sub-micron particulate 
filtration efficiency test" of " Fee-Charging 
Standards for Lot Release, Reference 
Materials, and Testing of Foods, Drugs and 
Cosmetics".   
Respiratory impedance  In accordance 
with CNS 14755  Fees are charged in accordance with "B015: 
Surgical masks sub-micron particulate 
filtration efficiency test" of " Fee-Charging 
Standards for Lot Release, Reference 
Materials, and Testing of Foods, Drugs and  Cosmetics".   
Note: When the inspection fees are calculated in foreign currency, Currency Exchange 
Rate Inquiry System provided by the Customs Administration, Ministry of Finance will be 
used to calculate the amount in New Taiwan Dollar.