China & India Launch New Medical Device Regulations (HealthPointCapital)
China and India have launched new regulatory guidelines for medical device companies conducting business within their respective countries.
China's State Food & Drug Administration (SFDA) released instructions governing a standardized manner in which foreign medical device manufacturers must label and package their products. The Circular, which is scheduled to take effect on April 1, 2013, included the following regulations: 1) Foreign medical devices that do not attach Chinese labels or packaging marks will be prohibited from being sold or expended in China; 2) Foreign manufacturers need to formulate relevant documents and effectively implement such documents to ensure the safety and effectiveness of the medical devices offered.
India's Drug Controller General of India (DCGI) will begin a national effort to ensure medical device manufacturers are producing safe and effective products by taking special measures to scrutinize business activities for discrepancies in manufacturing practices, which could impact the quality of the end product. DCGI also confirmed that serious considerations are taking plac...
