Annex II: The inspection methods and examination methodologies, items and scope to be checked of imported medical devices  
Item: Condom 
CCC Code Codes of 
classification  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 randomly selected. Randomly selected, batch 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 shall 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 batch 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. 
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 period of validity or shelf-life(limited in product with 
manufacturing date)in Chinese .For expiry date of the same series of mixed packaging, shall be based 
on the contents of a single package on the earliest date . 
 4014,10.00.10 ； 
4014,10.00.90 L5300；
L5310 Condom; 
Condom 
with 
spermicidal 
lubricant 4. If re-examination is required, resampling shall be proceeded according to the abovementioned 
requirements.  
  
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 be 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 deliveries. 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 achieved. 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 mask  
 
 
 
 
 
Surgical 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 Chinese 
National 
Standard 
Bacterial filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 According to 
CNS14774  
Differential pressure Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 According to 
CNS14774  
 
Project Inspection level Acceptable 
quality level Chinese 
National 
Standard 
Submicron filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 According to 
CNS14774  
Differential pressure Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 According to 
CNS14774  
 
Project Inspection level Acceptable 
quality level Chinese 
National 
Standard 
Submicron filtration efficiency  Special inspection S -2 (but the 
sample pronoun shall be at least E) 4 According to 
CNS14755  
Breathing air resistance Special inspection S -2 (but the 
sample pronoun shall be at least E)  4 According to 
CNS14755  
  