On the announcement of the first batch of the second class of medical equipment products do not need to apply for a "medical device business enterprise license" list of notice
State Food and Drug Administration City [2005] No. 239
Published on May 26, 2005
Provinces, autonomous regions and municipalities Food and Drug Administration (Drug Administration):
According to the State Food and Drug Administration Order No. 15, "Medical Device Registration", the State Food and Drug Administration (SFDA) has established a system for the registration of medical devices. 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 equipment product list developed by the State Food and Drug Administration". 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 13 products in 7 categories. 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 "Medical
Instruments Classification Catalog" (draft for comments).
Note