The State Drug Administration ("SDA") has recently issued the Guide to the Administration of Management Representatives of Medical Device Manufacturers (Draft for Comment) (the "Draft for Comment") for public consultation by May 10, 2018.
The Draft for Comment clearly specifies that each medical device manufacturer shall designate a management representative from its in-service employees and such representative shall meet six conditions, such as "being the vice general manager or a senior executive of the manufacturer". Further, the Draft for Comment stipulates that, a management representative of a medical device manufacturer shall fulfill ten duties, one of which reads "when the medical devices produced by this manufacturer are involved in major quality problems, he or she shall take an initiative to report the same to the drug regulator of the province, autonomous region or municipality directly under the Central Government at its locality". Additionally, the Draft for Comment notes that, if the management representative's refusal to fulfill his or her statutory duties, neglect of duties or malpractice gives rise to any of five circumstances, such as "where serious accidents regarding the quality of medical devices are caused", the manufacturer shall pursue the liability of the representative and report the case to the drug regulator.