China will build a medical device recall system

On the 6th, the "Legislation Regulations for Medical Devices (Revised Draft)" (Legislation Draft) of the State Council's legal office was publicly solicited from all sectors of society. The draft of the Opinions stipulates that the state will establish a monitoring system for adverse events in medical devices, and for the first time put forward a national system for the recall of medical device products.

Ads must be approved by the drug administration department

The draft of the Opinions stipulates that medical device advertisements should be approved by medical device registrants, drug regulatory agencies of the provinces, autonomous regions, and municipalities where the filers are located and obtain approval documents for medical device advertisements.

Advertising publishers who publish medical device advertisements should review the approval documents for advertisements and verify their authenticity. The pharmaceutical supervisory department at or above the provincial level shall order the suspension of the production, sale, and use of medical devices, and shall not publish advertisements for the medical device during the suspension period. Medical device advertisements should be authentic and legal, and must not contain false or exaggerated content. Otherwise, the drug regulatory department at or above the provincial level will decide to suspend the sale of the medical device and make it known to the public. If the medical device is still sold, the drug regulatory department at or above the county level shall confiscate the illegally sold medical device according to the statutory authority, and A fine of more than 10,000 yuan but less than 50,000 yuan.

Establish an adverse event monitoring system

The draft of the Opinions stipulates that the State shall establish a monitoring system for adverse events in medical devices and collect, analyze, evaluate, and control adverse events in medical devices.

Medical device production and operation companies, users and consumers who discover adverse events or suspected adverse events of medical devices shall report to the medical device adverse event monitoring technology institution in accordance with the provisions of the State Drug Administration. For medical device adverse events that cause bursts, mass injuries, or deaths, the drug administration department at or above the provincial level will organize investigations and treatment, and strengthen the monitoring of related medical device products.

Implanted devices ensure traceability to patients

According to the Exposure Draft, medical device manufacturers find that the medical devices they produce do not meet the national standards for medical devices and the technical requirements for medical device products. They should immediately stop production, recall medical devices that have already been marketed, and notify related producers and operators and consumers. Record recalls and notifications and publish relevant information.

At the same time, medical device manufacturers should take measures such as remedial actions and destruction of recalled medical devices, and report the recall and treatment of medical devices to the drug regulatory department. Where a medical device manufacturing enterprise fails to implement a recall or cease operation in accordance with the provisions of this article, the drug regulatory department may order it to recall or stop its operations.

Manufacturers and users of medical device production and operation shall make records in accordance with the provisions of these Regulations to ensure that the medical devices they produce, operate and use are traceable; for implantable medical devices, it shall be ensured that they can be traced back to the patients who implanted the medical device.