ABSTRACT
This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.
Subject(s)
Equipment and Supplies , Economics , Reference Standards , IndiaABSTRACT
The concept and classification of Korean medical device were introduced. The phases for Korea to import medical device include selecting Korean certification holder, hospital admittance, device marketing and supervision after marketing. China and other countries can find references to export medical devices into Korea.
ABSTRACT
Bacterial cellulose (BC) is a high-purity nanometer cellulose secreted by some bacteria. Compared with plant cellulose, it possesses an array of unique properties, including high crystallinity, high water content, good bio-compatibility, high mechanical strength and an ultra-fine fiber network. BC is prosperous as a new type of biomedical material, which has medical applications such as wound dressing, artificial skin, artificial blood vessels and tissue engineering scaffolds. There are, however, some problems to be solved on the large-scale application of BC, such as the high cost, low yield, and poor mechanical stability and so on.