In China, the National Medical Products Administration (NMPA) – previously the China Food and Drug Administration (CFDA) is responsible for pharmaceuticals and medical device regulations. Similar to the United States, medical devices are classified into three classes (from I to III), which are based on potential risk. When placing medical device products onto the Chinese marketplace, a number of things must be taken into consideration.
According to Richard Ghiasy of the Leiden Asia Centre; “Nations that lead [industrial revolutions] generally tend to lead the world.” China is already leading in the field of patent applications within the technology realm. In addition to this, the Chinese government has recognised that standardisation can be used as a strategic tool to assert its claim to leadership. In a recent brief to the Commission for Occupational Health and Safety and Standardisation, China’s ‘Standards 2035’ strategy announced the goal of occupying significant standardisation fields of technology and the goal to become the technological world market leader.