Hong Kong unveils online tool for IVD device classification

Moving to make complying with its emerging medical device regulations simpler, Hong Kong authorities have launched an online tool to help manufacturers of in vitro devices (IVDs) properly classify their products.

The platform unveiled by Hong Kong’s Medical Device Control Office (MDCO), is designed to give manufacturers a rough but accurate assessment of whether a particular product would be classified as Class A, B, C or D IVD under Hong Kong’s medical device regulations, known as the Medical Device Administrative Control System (MDCAS).

Last year, MDCO launched a similar online tool for the classification of non in vitro medical devices. The tools are for reference only.