Seek all the current do not need to apply for a license list of Class II medical devices

On the announcement of the first batch do not need to apply for "medical equipment business enterprise license" of the second class of medical equipment products list of notice State Food and Drug Administration City [2005] 239 No. 2005 May 26 issued Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration): According to the State Food and Drug Administration decree No. 15, "Medical Equipment Business License" of the second class of medical equipment products list developed by the State Food and Drug Administration, the State Food and Drug Administration, the State Food and Drug Administration, the State Food and Drug Administration and the State Food and Drug Administration. According to the State Food and Drug Administration Decree No. 15 "Medical Device Business License" 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" provisions, in consultation with the provinces (autonomous regions and municipalities) Food and Drug Administration on the basis of the State Food and Drug Administration validation, is hereby announced that the first batch of do not need to apply for "Medical Device Business License" of the medical device product list by the State Food and Drug Administration. Apply for a "medical device business license" of the second class of medical devices product list (hereinafter referred to as "List", see Annex). The published "List", *** counting 7 categories of 13 products. After the publication of the Directory, please do the relevant work in accordance with the requirements of the relevant regulations. Annex: the first batch of medical devices do not need to apply for "medical device license" of the second class of medical devices product list State Food and Drug Administration May 26, 2005 Annex: the first batch of medical devices do not need to apply for "medical device license" of the second class of medical devices product list

class code name │ product name │

│ General diagnostic instruments │ thermometer, Sphygmomanometer │

│ Physiotherapy equipment │ Magnetic therapy apparatus │

│ Medical hygiene materials and dressings │ medical cotton, medical cotton, medical gauze, medical sanitary masks │

│ Clinical testing and analyzing instruments │ home glucose meter, glucose test strips, pregnancy diagnostic test strips (test strips for early and early detection side of the test paper) │

│ Medical polymer materials and products │ condoms, Contraceptive caps │

│ Ward care equipment and appliances │ Wheelchair │

│ Dressings │ Medical Sterile Gauze │

Note: This directory of product class code name and product name based on the State Food and Drug Administration 2005 version of the "Classification of Medical Devices Directory" (draft for comment) to develop. Another batch of Class II medical devices operating without a license A few days ago, the State Food and Drug Administration announced the second batch of medical devices do not need "medical equipment business license" can operate Class II medical devices, "electronic blood pressure pulse meter; plum blossom needle; three pronged needles; acupuncture needles; ovulation test strips; handheld oxygen generator" **** four categories, six varieties. Four categories, six varieties. This is the State Bureau in 2005 announced the first batch of medical devices that do not require a "medical device business license" can be operated after the second announcement of Class II medical devices. These two published medical device varieties are used for a long time after the demonstration of the use of medical devices, the risk of use of medical devices is relatively safe. By adjusting the licensing conditions for medical devices, the State Bureau mainly facilitates the purchase and use of some medical devices by the public. However, the operators are required to obtain the relevant legal qualifications of the medical devices and carefully make acceptance records of the purchased products to ensure the quality of the medical devices. At the same time, the Food and Drug Administration to increase the publication of medical device-related regulations and technical standards for publicity and education and strict management. Once again, the city reminds the general public in the purchase of medical devices, must pay attention to check the relevant product qualification certificates, to ensure that the use of legal and qualified medical devices safety. Qiao Cheng District Branch Wang Changde November 18, 2011