Chapter I General Provisions  
Article 1  
 These regulations hav e been established according to 
Paragraph 2 of Article 71 -1 of the Pharmaceutical 
Affairs Act.  
Article 2  Definition: terms used in these regulations:  
1. Inspections: This refers to spot checks or examination
before permitting the importation of medicaments  
2. Examination: This refers to conducting sensory,
chemical, biological, or physical tests in a laboratory.  
3. Inspe ction authorities: This refers to inspection
enforcement by the central competent health authority or 
its appointed agencies (organizations).  
4. Obligatory inspection applicants: This refers to
medicaments importers.  
Chapter II Imported Drugs Inspection  
Article 3  
 For drugs required for inspec tion by the competent 
authority, the obligatory inspection applicants shall 
submit the following documents to the inspection 
authority to carry out the inspection:  
1. An application form for inspection.
2. A copy o f medicaments permit license  or import
certificate issued by the central competent health 
authority .  
3.A copy of application for import declaration.
4. Necessary documents required by the central
competent authority.  
The application of the preceding para graph can be 
submitted electronically.  
Drugs pursuant to the first Paragragh that conform to one 
of the following situations can be exempted from 
inspection:  
1. Products to be imported are issued with a certificate of
examination by the government of the c ountry of origin 
who has signed an examination waiver reciprocity 
agreement with the government of the Republic of 
China.  
2. A special permit from central competent health
authority granted for national emergency situation or to Regulations for the Inspection and Examination of Imported Medicaments
 (Amended text highlighted in yellow)improve the public welfare.  
Article 4  
 In addition to documentation r eview (as prescribed in 
Article 3), inspection authority can carry out the 
inspection of drugs in one or some of the following 
measures:  
1. Batch -by-batch examination: carried out for each
submitted batch of drugs.  
2.Randomly -selected batch examination: performed
based on a 2% -50% inspection rate.  
3. On -site inspection: inspecting and checking
(hereinafter referred to as ‘verification’) of items, 
packaging, appearance and labels of products on site.  
Article 4-1 For active pharmaceutical ingredient s (as raw materials 
in Article 16 of Pharmaceutical Affairs Act ) that belong 
to classification cod es in Chapters 28 and 29 of the  
Import and Export Commodity Classification of the 
Republic of China, management  of randomly -selected 
batch examination in Subparagraph 2 of the foregoing 
article are as follows:  
1.For those  randomly -selected :
(1) Testing is done through rapid test instruments. Once 
determined as illicit drugs, they are to be forwarded 
to the customs or judicial/police authority for 
investigation . 
(2)  When test results cannot be determined or it is 
impossible to perform testing with rapid test ing 
instruments, they shall be sealed immediately and 
may not be unpacked without authorization.  
(3)  For drugs that are  sealed  according to preceding  
item, the inspection authority may issue the notice 
allowing prior release of imported drugs to fac ilitate 
customs declaration after the applicant has prepared 
the affidavit as required by Article 18 and enclose d 
supporting documents for compliance of the storage 
site with the Regulations for Good Manufacturing 
Practice  or having filed for reference wit h the 
competent municipal and county (city) health 
authority. The storage site, without prior approval from the inspection authority, may not be changed 
unilaterally.   
(4)  The applicant indicated in the preceding ite m shall  
proactively  notify the inspection authority for 
sending staff to the location compliance with the  
Pharmaceutical Good Manufacturing Practice 
Regulations for unsealing  and examination . Those 
having met requirements shall be managed  according 
to Article 19.   
(5) The quantities involved in the randomly -selected 
batch examination are indicated in A nnex  1. 
2. For batches  not being selected , the inspection 
authority will review the application documents. 
Those having met requirements shall be managed  
according to Article 19.  
Article 5  
  Reference standard and methods for the examination of 
imported drugs should abide to those mentioned in the 
Chinese Pharmacopoeia, pharmacopoeias published in 
the A10 countries or otherwise publicly announced by 
the central health competent authority.  
Chapter III Imported Chinese medicine materials inspection  
Article 6  
  Imported Chinese medicine materials shall not change 
the form of original material or tablets ready for 
decoction ,and  the labels or packages shall indicate name 
of the medicament , lot number, name and address of the 
pharmaceutical firms.  
Reference standard and methods for the examination of 
imported Chinese medicine materials should abide to 
those mentioned in the Chine se Pharmacopoeia, 
pharmacopoeias published in Taiwan Herbal 
Pharmacopeia or otherwise publicly announced by the 
central health competent authority.  
Article 7  
  For the Chinese medicine materials required for 
inspection by the competent authority, the obl igatory 
inspection applicants shall submit the following 
documents to the inspection authority to carry out the 
inspection:  
1. An application form for inspection.  2. A copy of Chinese medicines pharmaceutical firms 
permit license.  
3. A copy of application for import declaration.  
4. A certificate of examination issued by the laboratories 
approved by central health competent authority, Chinese 
medicine manufacturers in compliance with 
Pharmaceutical Good Manufacturing Practice 
Regulations, or related competen t authority from the 
country of origin.  
5. Necessary documents required by the competent 
authority.  
The application of the preceding paragraph can be 
submitted electronically.  
Chinese medicine materials that conform to one of the 
following situations can b e exempted from inspection:  
1. Products to be imported are issued with a certificate of 
examination by the government of the country of origin 
who has signed an inspection waiver reciprocity 
agreement with the government of the Republic of 
China.  
2. The sa mples are permitted to import by the central 
competent health authority for the certificate of 
inspection pursuant to the fourth sub -paragraph of the 
first paragraph.  
3. A special permit from central competent health 
authority granted for national emergenc y situation or to 
improve the public welfare.  
Article 8  
  In addition to documentation review (as prescribed in 
Article7), inspection authority can carry out the Chinese 
medicine materials inspection in one or some of the 
following measures:  
1. Batch -by-batch examination: The inspection is carried 
out for each submitted batch of Chinese medicine 
materials.  
2. Randomly -selected batch examination: The inspection 
is performed based on a 2% -50% inspection rate.  
3. On -site inspection: verification of items, packaging, 
appearance and labels of products on site.  Article 9  
  If any violation of Article 6 is found during the on -site 
inspection for the Chinese medicine materials , a notice 
shall be given by inspection authorities and the 
obligatory inspec tion applicants shall make correction 
within a prescribed time period; and submit to recheck 
afterwards.  
Chapter IV Imported medical devices inspection  
Article 10  
  For the medical devices required for inspection by the 
competent authority , the obligat ory inspection applicants 
shall submit the following documents to the inspection 
authority to carry out the inspection:  
1. An application form for inspection.  
2. A copy of medical devices permit license.  
3. A copy of application for import declaration.  
4. Necessary documents required by the competent 
authority.  
The application of the preceding paragraph can be 
submitted electronically.  
Medical devices that conform to one of the following 
situations can be exempted from inspection:  
1. Products to be imported  are issued with a certificate of 
examination by the government of the country of origin 
who has signed an inspection waiver reciprocity 
agreement with the government of the Republic of 
China.  
2. A special permit from central competent health 
authority gra nted for national emergency situation or to 
improve the public welfare.  
Article 11  
  In addition to documentation review (as prescribed in 
Article  9), inspection authority can carry out the medical 
devices inspection in one or some of the following 
measures:  
1. Batch -by-batch examination: The inspection is carried 
out for each submitted batch of medical devices.  
2. Randomly -selected batch examination: The inspection 
is performed based on a 2% -50% inspection rate.  
3. On -site inspection: verification o f items, packaging, 
appearance and labels of products on site.  The methods for inspection and the items and 
methodologies for examination of imported medical 
devices as prescribed in Annex II. 
 Annex II；Theinspection methods ande xamination 
methodologies, items and scope to be checked of 
imported medical devices.doc  
 
Chapter V Others  
Article 12  
  In the event the medicaments applied for inspection 
correspond to one of the following situations, the 
competent authority may require the obligatory 
inspection applicant to provide written documentation 
before a given date, to explain the reasons for 
non-conformance, and a proposed improvement plan 
with preventative measures:  
1. Same product applied for batch -by-batch examination  
by the same obligatory examination applicant does not 
conform to regulations for the second time.  
2. Products belong to the same origin of medicaments 
permit license, and whose inspection results do not 
conform to regulations for three times within 180 da ys. 
3. Chinese medicine materials belonging to the same 
origin, same country and same commodity classification 
code of the Republic of China, and whose inspection 
results do not conform to regulations for three times 
within 180 days.  
Article 13  
  In the event the medicaments applied for inspection 
correspond to one of the following situations, the 
competent authority may temporarily suspend the 
application for inspection from the same manufacturer, 
same origin, or same country:  
1. Products mentioned in th e preceding article and the 
written documentations provided are not approved upon 
review.  
2. Products mentioned in the preceding article requiring 
written documentations are not provided before the given 
date or the following imported products applied for 
inspection still do not conform to regulations by the 
given date.  
Article 14  
  The obligatory inspection applicant shall file an 
application to the inspection authority at the port where 
the medicaments are to be imported, 15 days prior to the 
date of in spection.  
If the representative files the application, an 
identification document for the representative shall be 
provided. The representative shall submit a letter of 
Power of Attorney and shall register at the inspection 
authority.  
Article 15  
  The samples required for inspection shall be taken 
free-of-charge. The maximum number (amount) of 
sampling shall be limited to what is required for 
laboratory examination and sample retention purposes. 
After collecting the samples, the authority shall issue a 
receipt for sampling to customs officials and the 
obligatory inspection applicant.  
Article 16  
  Inspectors shall conduct random sampling at port. If 
samples are difficult to be sampled at the port, the 
inspection authority shall designate an alternative 
sampling location.  
For the above mentioned sampling, the obligatory 
inspection applicant shall not designate the sample.  
Article 17  
  Examination shall be conducted in the order of sampling. 
However, the examination laboratory shall prioritize 
inspection  on products applying for re -examination 
according to these regulations.  
Article 18  
  For inspection of medicaments, that are difficult to 
sample in a container yard, require five or more days for 
examination at the laboratory, perishable, or lack 
stabil ity on safety effica cy, 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 Affidavit. The inspection authority may 
issue a Notice of Prior Release for Import for customs 
clearance since the necessity of examination.  
If the pledged storage location does not conform to the 
actual storage location, or medicaments are put to use before receivin g 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 180 days.  
Article 19  
  After medicaments applied for inspection are found to 
conform to the regulations, the inspection authority shall 
issue a medicaments import notification ,the obligatory 
inspection applicant can apply to the inspection authority 
for a notification of the medicaments import admitted.  
The obligatory ins pection 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 author ity 
may dispose of the samples directly.  
Article 20  
  In the event the medicaments fail to conform to 
regulations, a notification of noncompliance for 
medicaments will be issued.  
The obligatory inspection applicant can apply for 
re-examination to the ori ginal inspection authority within 
15 days after receipt of the notification of results. 
Applications for re -examination is limited to one time 
only, and are performed by the original testing laboratory 
using remaining samples for the re -testing. For medica l 
devices, if the remaining samples are not adequate for 
re-examination, additional sampling may be done 
according to Article 15.  
Remaining samples of products that do not conform to 
regulations shall be destroyed after the end of the period 
of application  for re -examination, unless otherwise stated 
by law.  
Article 21  
  For imported medicaments 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 products that have been released via a prior 
release notice do not conform to regulations mentioned 
in the preceding paragraph, the competent authority shall order the obligatory inspection applicant to retrieve the 
medicaments, and ship back or de stroy the medicaments 
according to the preceding paragraph.  
Chapter VI Statutory Fees  
Article 22  
  The statutory fees for Inspection of Imported 
Medicaments shall include the following:  
1. Review fees;  
2. On -site inspection fees;  
3. Certificate fees;  
4. Examination fees;  
The inspection fees in the preceding paragraph is 
described in Annex III. 
 Annex I II.doc  
 
Chapter VII Supplementary Provisions  
Article 23  
  When conducting on -site inspections according to these 
regulations, inspectors shall carry their identification 
documents with them.  
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.  
Annex I  
Quantities of 
APIs in random 
batch inspection  One piece is to be randomly 
inspected whe n the total 
number of pieces is  within 
50; two  when it is between 
51 and 100; three when it is 
between 101 and 500; four 
when it is between 501 and 
1000; and five when it is 
more than 1,000.  
 
 
  Annex II: The inspection  methods and  examination  methodologies, items and scope to be checked of imported medical devices  
Item:  Condom  
CCC Code  Codes of 
classificatio
n Item 1. Inspection  methods and frequency ： 
Condoms with the same obligatory inspection applicant, same  items, same manufacturing 
brand , same origin, same type, same thickness or specification are subjected to 
batch -by-batch examination.  
For first  inspection submission, randomly -selected batch inspection shall apply for those 
require compliance for3 consecutive batches.  
For one out of three batches  will be r andomly  selected. Randomly selected, batc h shall be 
for examined,  while those not randomly -selected are subjected to on -site inspection.  
If non -conformities are found during the randomly -selected batch inspection  process, the 
originally announced procedure  of 3 consecutive batch examination shal l be applied before 
permitted for randomly -selected inspecting require.  
 
2. On-site inspection:  
Items to be inspected: packaging, appearance and labels of products including:  name of the 
product, name and address of the manufacturer, date of manufacture or b atch number, or 
expiry date.  
 
3. Examination  items:  
Randomly selected 315 samples  per batch  of 500,000  or below, and 500 samples  per batch  
of 500,001  or above.  4014,10.00.10 ； 
4014,10.00.90  L5300；
L5310  Condom; 
Condom 
with 
spermicida
l lubricant  The ratio of Acceptable Quality Level (AQL) in accordance to ISO 2859 -1, and the 
following test items are as follows according to Chinese National Standards (CNS) 6629 
T2008 Standard of latex condom.  
Items  Testing Levels  Acceptable Quality Level(AQL)  
Appearance  Normal test  Ι(at least for the sample code M ) 0.4 
Pin-hole test  Normal test  Ι(at least for the sample code M ) 0.25 
Labeling  Must fully comply with all requiring   
Note: Minimum package shall label  in Chinese for the following items: name of the product, date 
of manufacture or batch number, expiry date, and name and address of the manufacturer(import 
manufacturer may label in foreign languages),  Medical device permit number and the importer. 
Single unit shall at least label date of manufacture or batch number ,name of the manufacture or 
brand(imported excluded) ,expiry date, and per iod of validity or shelf -life(limited in product with 
manufacturing date)in Chinese .For expiry date of t he same series of mixed packaging,  shall be 
based on the contents of a single package on the earliest date .  
 
4. If re -examination is required, resampling shall be proceeded according to the 
abovementioned requirements.  
 
  Annex III 
Item  The level of fees （NT＄）  
1. Inspection fees  Inspection fees  shall be calculated based on CIF for the following rates:  
1.For import Chinese medicine materials  Fee rate: 0.15%,Minimum fee: NT$200,If the 
inspection fee is more than NT$100,000, the portion above NT$100,000 shall be collected 
at the rat e of 0.075%.  
2 For imported drug Fee rate: 0.25%,Minimum fee:NT$500,Iftheinspection fee is more 
than NT$100,000, the portion aboveNT$100,000 shall be collected at the rate of 0.125%.  
No inspection fee is required for active pharmaceutical ingredient s. 
3.For imported medical device Fee rate: 0.25%,Minimum fee: NT$500,If the inspection 
fee is more than NT$100,000, the portion above NT$100,000 shall be c ollected at the rate 
of 0.125%.  
2.On -site fee     A  NT$500 on -site fee for each person each time shall be collect during weekdays 
from 8:30 A.M. to 5:30 P.M. according to Government Agencies Working Calendar.  
  The following extended operational hours ,an extra fee shall be collected  1.During 
weekday,  from 6:00 AM to 8:30 AM or from 5:30 PM to 10:00 PM. An NT$400 fee for 
each batch of commodities shall be collected.  
2. During weekends and statutory holidays shall be from 6:00 a.m. to 10:00 p.m.. An 
NT$1,000 fee for each batch of commodities shall be co llected.  
3. A fee of NT$2,000 shall be collected for activities taking place outside the operational 
hours mentioned in the preceding items 1) and 2).  
 If the inspector cannot commute to the place of inspection and back within the same 
day, the on -site fee s shall be collected in accordance with the costs and expenses set 
forth in the “Operating Guidelines Governing Dome stic Business Travel Expenses”.  
   No on-site fee is required for active pharmaceutical ingredient s. 3.Certificate fee:  NT$100 shall be collected for each new , replacement or chan ge permit items of certificate.  
4.Examination fee  Examination fee means fee for re -examination of import medicaments or whose 
examination results do not conform to randomly -selected batch examination and are back  
for batch -by-batch examination.  
Serial number  Examination items  Directions  Amount of fees collected  
Chinese medicine materials  Fees are collected based on 
Fee-Charging Standards for Lot 
Release, Reference Materials, and 
Testing of Foods, Drugs and 
Cosmetics.  A005  Heavy metal  By Colorimetric test method per item  
 
E011  Mercury   
E012  Arsenic   
E013  Lead   
E014  Copper   
E015  Cadmium   
E016  Organochlorine   
E017  Alfatoxins   
B1, B2, G1, G2   
Medical devices  
A001  General inspection  
(condom  
appearance ) Visual defects (serious or non -serious)  
B006  Condom：Pin hole 
test According to CNS6629  APIs   
    A002       Identification           It is calculated by each component or in each method . 
Note : All fees are  denominated in  New Taiwan Dollar.  Fees based on commodity prices that are denominated in foreign currencies shall be 
converted into New Taiwan Dollars, based on the exchange rates stipulated by the Customs Bureau and applicable for successive  ten-day 
periods.