On February 13, the CFDA official website released the "Announcement on the Definition of the Attributes of Pharmaceutical and Pharmaceutical Products", and announced the results of the definition of the attributes of the medical equipment products since 2009 (85 of which were defined and 4 of which were approved for listing). ), designed to guide applicants to declare properly.
Announcement on the definition of the properties of pharmaceutical and pharmaceutical products (No. 181)
In order to guide the applicant to make a reasonable declaration, the results of the definition of the attributes of the medical equipment combination products since 2009 have been announced. Of these, 85 were defined (see Annex 1) and 4 were approved for listing (see Annex 2).
Special announcement.
State Administration of Food and Drug Administration Administrative Reception Service Hall
February 13, 2017
attachment1. Summary of the definition of the properties of the medical device combination product
Chitosan is a product of n-deacetylated chitosan. Chitin, chitosan and cellulose have similar chemical structure. Cellulose is hydroxyl group at C2 position, chitin and chitosan are replaced by an acetyl group and an amino group respectively at C2 position. Chitin and chitosan have many unique properties such as biodegradability, cell affinity and biological effect, especially chitosan containing free amino group, which is the only basic polysaccharide in natural polysaccharides.
The amino groups in the chitosan molecular structure are more reactive than the acetylamino groups in the chitin molecule, which makes the polysaccharide have excellent biological functions and can carry out chemical modification reaction. Therefore, chitosan is considered as a functional biomaterial with greater application potential than cellulose.
Chitosan is the product of natural polysaccharide chitin removing part of the acetyl group, with biodegradability, biocompatibility, non-toxicity, antibacterial, anti-cancer, lipid-lowering, immune enhancement and other physiological functions. Widely used in food additives, textile, agriculture, environmental protection, beauty care, cosmetics, antibacterial agent, medical fiber, medical dressings, artificial tissue materials, drug slow release materials, gene transduction carrier, biomedical fields, medical absorbable materials, tissue engineering carrier materials, medical and drug development, and many other fields and other daily-use chemical industry.
Chitin,Chitosan,Chitosan Oligosaccharide,Carboxymethyl chitosan
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