Notice on the publication of the first batch of Class II medical device products do not need to apply for a "medical device business enterprise license" of the list of medical devices
State Food and Drug Administration City [2005] No. 239
Provinces, autonomous regions and municipalities Food Drug Administration (Drug Administration):
According to the State Food and Drug Administration Order No. 15, "Medical Device Business License Management Measures" in the "do not need to apply for a "Medical Device Business License" of the second class of medical device product list by the State Food and Drug Administration to formulate" provisions. Provisions, in consultation with the provinces (autonomous regions and municipalities) Food and Drug Administration on the basis of the views of the State Food and Drug Administration, the State Food and Drug Administration validation, is now published in the first batch do not need to apply for a "medical device business enterprise license" of the second class of medical device product list (hereinafter referred to as the "directory", see Annex).
The published "Directory", *** counting 7 categories of 13 products. After the publication of the Directory, please follow the requirements of the relevant regulations to do a good job.
Attachment: The first batch does not need to apply for "medical device business license" of the second class of medical devices product list
State Food and Drug Administration
May 26, 2005
Attachment:
The first batch of the first batch of medical devices does not need to apply for "medical device business license"
The second class of medical devices Product List
┌──────────┬───────────────────────────┐
│ Class Code Name │ Product Name │
├──────────┼───────────────────────────┤
│ General Diagnostic Instruments │ Physical therapy equipment │ Thermometers, blood pressure monitors │
├￥──────────┼?───────────────────────────┤
│ Physical therapy equipment │ Magnetic therapy appliances │
├￥──────────┼?───────────────────────────┤
< p>│Medical hygiene materials and dressings │Medical degreasing cotton, medical degreasing gauze, medical sanitary masks │├óΓé?┼?──────────┼?───────────────────────────┤
│Clinical testing and analyzing instruments │Household blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test side test strips) │
< p>├──────────┼───────────────────────────┤│Medical polymer materials and products │ condoms, contraceptive caps │
├──────────┼───────────────────────────┤
│Ward Care Equipment and appliances │ Wheelchairs │
├──────────┼───────────────────────────┤
│ Dressings │ Medical Sterile Gauze │
└──────────┴───────────────────────────┘
Remarks: This The product class code name and product name in the directory are based on the State Food and Drug Administration 2005 version of the "Medical
Instruments Classification Catalog" (draft for comments).
On the announcement of the second batch does not need to apply for "medical device business enterprise license" of the second class of medical devices product list of the notice
State Food and Drug Administration [2011] No. 462
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration):
According to the "Medical Device Business License Management Measures" (State Food and Drug Administration Decree No. 15), the State Food and Drug Administration has adopted the "Medical Device Business License Management Measures" (State Food and Drug Administration Decree No. 15). (State Food and Drug Administration Order No. 15) in the "do not need to apply for" medical device business license "of the second class of medical devices product list by the State Food and Drug Administration to develop" the provisions of the provinces (autonomous regions and municipalities) Food and Drug Administration in consultation with the views of the basis, by the State Food and Drug Administration Validation, is now published in the second batch do not need to apply for "medical device business license" of the second class of medical equipment products list (see annex).
The published list, ***6 products. After the publication of the directory, please do the relevant work in accordance with the requirements of the relevant regulations.
Attachment: the second batch does not need to apply for "medical device business enterprise license" of the second class of medical device product list
State Food and Drug Administration
November 3, 2011
Attachment:
The second batch of does not need to apply for "medical device business enterprise license" of the
Second class of medical devices Product List
Product Name
Class Code
Electronic Blood Pressure Pulse Meter
6821
Plum Blossom Needle
6827
Triple Pronged Needle
6827
Moxibustion Needle
6827
Ovulation Detection Test Strip
6840
Portable Oxygen Generator
6854
Note: 1. The operation of the medical device products listed in this directory (based on the name of the product listed in the certificate of registration of the medical device) is not required to obtain the "Medical Device Operator License".
2. The product names and class codes in this list are based on the State Food and Drug Administration 2002 version of the "Medical Device Classification Catalog" to determine.