Medical device instructions must not boast about cure

In order to comply with the “Regulations on the Supervision and Management of Medical Devices” implemented from June 1 this year, the State Food and Drug Administration announced on the 1st the revised “Administrative Measures for Registration of Medical Devices,” “Management Regulations and Labeling for Medical Devices,” and “Medical Five regulations, including the Regulations for the Supervision and Management of Appliances, will be implemented on October 1.

According to reports, the revised five regulations set the product registration (filing) as well as the conditions, procedures, and time limits for product production and business licenses in accordance with the degree of risk of medical device products, and clearly defined the company's main obligations and responsibilities. The requirements of manuals and labels were strengthened, and the means and measures for supervising and inspecting the supervision departments were strengthened. The legal responsibilities were strictly enforced, which provided strong support for strengthening the supervision and treatment of medical devices. Among them, the "Medical Device Manual and Label Management Regulations" clearly require that future medical device manuals and labels may not contain "the best efficacy," "guarantee to cure," "border," "radical cure," "immediately effective," and "completely non-toxic and side effects." Assertions of efficacy must not contain promised language such as "invalid refund", "insurance company insurance", and description of cure rate or efficiency.

The "Measures for the Supervision and Management of Medical Device Production" clearly states that local food and drug regulatory authorities shall conduct credit evaluations for medical device manufacturers and establish credit files; for enterprises with bad credit records, they shall increase the frequency of inspections; For enterprises that report complaints or are exposed by the media, the food and drug regulatory authorities may conduct legal interviews with legal representatives or business leaders. For enterprises listed on the "black list", they shall be implemented in accordance with relevant regulations. If a factory medical device fails to carry out inspection in accordance with regulations, conceals relevant conditions from the supervision and inspection authorities, and provides false information, it will be fined up to 30,000 yuan.