Notice on the publication of the first batch of second-class medical device products that do not need to apply for the License for Medical Device Business Enterprises
State-owned US Food and Drug Administration [2005] No.239
Published on May 26th, 2005.
SFDA of all provinces, autonomous regions and municipalities directly under the Central Government:
According to 15 Administrative Measures for Medical Device Business License issued by the US Food and Drug Administration, the second category of medical device products that do not need to apply for the Medical Device Business License are formulated by the US Food and Drug Administration. On the basis of consulting the food and drug administrations of all provinces (autonomous regions and municipalities) and being approved by the State Food and Drug Administration of the United States, the first batch of medical device business licenses need not be applied again.
The catalogue published this time * * * includes 7 categories 13 products. After the catalogue is published, please do relevant work in accordance with relevant regulations.
Attachment: The first batch of Class II medical device products that do not need to apply for the License of Medical Device Business Enterprise.
SFDA
Press release issued on 26 May 2005
Attachment:
The first batch does not need to apply for the Medical Device Business License.
List basis of the second category of medical device products
┌──────────┬───────────────────────────┐
│ Category code │ Product name
├──────────┼───────────────────────────┤
General diagnostic instruments, thermometers and sphygmomanometers
├──────────┼───────────────────────────┤
Physical therapy equipment, magnetic therapy equipment
├──────────┼───────────────────────────┤
Medical sanitary materials and dressings, medical absorbent cotton, medical absorbent gauze and medical sanitary mask.
├──────────┼───────────────────────────┤
Clinical test and analysis instrument, home blood glucose meter, blood glucose test paper, pregnancy diagnosis test paper (early pregnancy test paper),
├──────────┼───────────────────────────┤
Medical polymer materials and products, condoms and contraceptive caps
├──────────┼───────────────────────────┤
Ward nursing equipment and appliances wheelchair
├──────────┼───────────────────────────┤
Medical aseptic gauze dressing
└──────────┴───────────────────────────┘
Remarks: The product category codes and product names in this catalogue are based on the national US Food and Drug Administration's 2005 edition of Health Care.
Classification catalogue of instruments (draft for comments).