Draft Regulations Governing Border Inspection and Examination of Imported Medical 
Devices  
Articles  Description  
Chapter I General Provisions  Name of chapter  
Article 1 The present regulations are 
stipulated in accordance with Paragraph 
2, Article 52 of the Medical Devices Act 
(hereinafter referred to as "the Act").   Article 52 of the Act stipulates that 
"(Paragraph 1) medical device items 
designated by the central competent 
authorit y may only be imported after 
passing required random tests or inspections 
at the time of import" and "(Paragraph 2) 
regulations governing the items, manners, 
methods, scope, and fees of the random tests 
and inspections of the imported medical 
device set fo rth in the preceding paragraph, 
and other matters to be complied with shall 
be established by the central competent 
authority." These two paragraphs are the 
legal basis for the stipulation of the present 
regulations.   
Article 2 Terms used in the present 
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 organization(s) 
appointed or commissioned by the 
central competent authority.  
5. Obligatory inspection applicants: This 
refers to importers of medical 
devices.  Definitions of key terms used in the present 
regulations.   
Chapter II Application for Inspection of 
Imported Medical Device  Name of chapter   
Article 3 Provisions governing medical 
device items requiring border  inspection 
by the central competent authority are 
listed in Annex I.   In accordance with the provisions of 
Paragraph 2 of Article 52 of the 
Regulations, medical device items requiring 
border inspection by the central competent 
authority are shown in the A nnex of the 
present regulations.   
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 copy of medical devices permit 
license.   
2. A copy of application for import 
declaration.   
3. Other documents, information or 
packaging and label designated by 
the central competent authority.   
4. If the application is to be filed by a 
representative, an identification 
document for the representa tive and 
a letter of power of attorney shall be 
provided unless the obligatory 
inspection applicant has notified the 
inspection authority of the 
entrustment.   
The central competent authority may 
require the obligatory inspection 
applicant to submit the app lication of the 
preceding paragraph electronically.   
In the event that the inspection 
authority discovers that the application 
documents and information are not 
complete, the inspection authority shall 
notify the obligatory inspection applicant 
who shall m ake corrections within 20 
days. In the event that the applicant fails 
to make corrections before the designated 
deadline, the application shall be rejected.   Stipulates that the obligatory inspection 
applicant shall file the completed 
application form and submit the following 
documents and information to the inspection 
authority 15 days prior to the date of 
inspection and may require the application 
to be submitted electronically.   
 
 
 
 
 
Article 5 Imported medical devices conform 
to one of the following situations can be 
exempted from inspection referred to the 
preceding Article:  
1. Imported medical devices are for Stipulates the situations when imported 
medical device does not require inspection. 
For example, in accordance with the 
provisions of Paragraph 4 of Article 35 of 
the Act, imported medical devices for  
exclusive use as samples or for 
personal use only in accordance with 
the provisions of Paragraph 4 of 
Article 35 of the Act.   
2. Imported medi cal devices are 
originally manufactured 
domestically for export and 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.   exclusive use as samples or for personal use 
only, or i n accordance with the provisions 
of Article 25 of the Act, exported product 
originally manufactured domestically to be 
shipped back to Taiwan with the approval of 
the Administration.   
Chapter III Inspection Procedures  Name of chapter  
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.   
Inspection items, test items and 
testing methods of imported medical 
devices as prescribed in Annex II.   Stipulates the methods to inspect imported 
medical devices; and stipulates that 
inspection methods, test items and methods 
are listed in the Annex of the present 
regulations.   
Article 8 Imported medical device applied 
for inspection that belong to one of the 
following s ituations shall be inspected on 
a batch -by-batch basis:  Stipulates the conditions for batch -by-batch 
inspection of medical devices.    
1. The first three batches of impor ted 
medical devices with the  same item 
name, same trademark (brand name) 
and same origin imported by the 
obligatory inspection applicant.   
2. Reinforced random -selec ted 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 for the preceding 
batch, the batches re -applied for 
inspection to such batch 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 inspec ted 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 
regulations.   
2. The inspection authority determines 
that it is necessary to carry out 
reinforced batch -by-batch 
inspection.   Stipulates the conditions for reinforced 
randomly -selected batch inspection of 
medical devices.   
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 ac cordance with the 
provisions of Subparagraph 1, 
Paragraph 1 of Article 7 is 
conformity with the regulations.  
2. The inspection results of the previous Stipulates the conditions for regular 
randomly -selected batch of medical devices.    
five batches in a row in accordance 
with the provisions of Subparagraph 
2, Paragraph 1 of Article 7 or 
preceding Article are conformity 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 
what is required for examination.   
After collecting the samples, the 
inspection authority shall issue a receipt 
for sampling to th e obligatory inspection 
applicant.   Stipulates that the inspection authority may 
take samples required for inspection free of 
charge and the number of sampling.   
Article 11 Sampling of inspection shall 
conduct in the place where the products 
were stored.   
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.   Stipulates the sampling method and location 
for imported medical device.   
Article 12 Examination shall be conducted 
in the order of sampling. However, the 
examination laboratory shall prioritize 
inspection on products applying for re -
examination in accorda nce with Article 
15.  Stipulates the timing of examination of 
imported medical device.   
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 with an Stipulates that imported medical device may 
be granted notice of prior for import with an 
Affidavit and the consequences when the 
content of the Affidavit is not followed.    
Affidavit of I mported Medical Device.   
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 o f 1 year.   
Article 14 In the event that imported 
medical device conforms to regula tions, a 
notification of import permit will be 
issued to the obligatory inspection 
applicant; the obligatory inspection 
applicant may apply for the inspection 
authority to issue a written import permit.   
The obligatory inspection applicant 
can claim remain ing 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.   Stipulates the follow -up procedures after 
imported medical device are found to 
conform with regulations after inspection, 
including issuance of written permit and 
disposal of remaining samples.   
Article 15 In the event that imported 
medical device  fail to conform to 
regulations, 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 -
exami nation, additional sampling may be 
done according to Article 11.   
For medical devices that do not 
conform to regulations upon inspection, 
as referred to in Paragraph 1, the Stipulates the follow -up procedures when 
imported medical device fail to conform 
with regulations after inspection, including 
issuance of a notification of noncompliance, 
application for re -exam ination and disposal 
of remaining samples.    
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 regulations upon 
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 regulations, the 
inspection authority notify the obligatory 
inspection applicant to dispose the 
medical devices in accordance with the 
provisions of the preceding Paragrap h 
and notify the municipality (county/city) 
competent authority.   Stipulates the disposal of the shipment of 
nonconforming imported medical device.   
Chapter VI Statutory Fees  Name of chapter  
Article 17 The obligatory inspection 
applicant shall pay all or  part of 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 Annex 3.   Stipulates the charges for inspection of 
imported medical device.   
Chapter V Supplementary provisions  Name of chapter  
Article 18 Inspectors shall carry and present 
their identificat ion papers when 
conducting field inspections under the 
present regulations.   Stipulates that inspectors shall carry their 
identification documents with them when 
performing inspection.   
Article 19 These regulations shall be 
implemented on the date of promulgation 
of "the Act".   According to Article 85 of the Act, the date 
for enforcing the Act shall be determined by 
the Executive Yuan and the present 
regulations will follow the date of 
promulgation of the Act.   
 
 
   
Annex 1  
Item 
No. Item Name  Classific ation 
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  
   
Annex II: Verification items, test items and testing methods of imported medical devices.  
 
Annex I: Item No. 1, 2: condom  
 
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  
 
  
Annex I: Item No. 3, 4: General 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:  
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  In accordance with CNS 14774  
Pressure difference  In accordance with CNS 14774  
N95 mask  
Test item  Testing methods  
Sub-micron Particulate Filtration Efficiency  In accordance with CNS 14755  
Respiratory impedance  In accordance with CNS 14755  
 
  
Annex 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 0.2% 5. When the review fees 
is less than 500 NTD, 500 NTD will be charged. When the review fees is 
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 
inspe ctions 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. Notification fees;  The fees for re -issuance, replacement, additional copy, or correction of 
the notification of import permit of import.ed 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 char ged for each application. The fees include a copy of 
re-issued permit with notification stating the correction.   
5. 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 Fees are charged in accordance with "A001: General 
test" of " Fee -Charging Standards for Lot Release,  
severe)  Reference Materials, and Testing of Foods, Drugs 
and Cosmetics".   
Condom pin -hole test  In accordance with 
CNS 6629  Fees are charged in accordance with "B 006: 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.