Can the new medical device supervision rules balance innovation and risk?…

From June 1, the revised "Medical Device Supervision and Administration Regulations" was officially implemented. This is the first revision of the medical device supervision regulations in my country in 14 years. This means that the supervision and market operation of medical devices have entered a new stage.

Public data shows that there are about 15,000 medical device manufacturers in my country, with a statistical output value of more than 200 billion yuan in 2013. From tongue depressors to heart stents and CT detectors, medical devices have become an industry with a wide range of categories, many companies, and rapidly growing industrial value.

The rapid development of the industry has posed challenges to supervision, and the original regulations have been criticized in the industry.

Since the beginning of March this year, a series of activities by regulatory authorities on medical device management have been carried out. First, the State Food and Drug Administration revised the new supervision regulations, and then the department launched the five rectification activities of medical devices with great fanfare, and then the medical device Wanlixing, and the "Medical Device Use Quality Supervision and Management Measures (Draft for Comments)" were issued.

Faced with the newly revised regulations, some people once questioned whether supervision was being relaxed. But in fact, this is a change in the regulatory thinking. The supervision of medical devices has shifted from focusing on prior supervision to focusing on process supervision.

This change is reflected in all aspects from production, operation to post-market monitoring and punishment. For example, manufacturers must submit self-inspection reports to regulatory authorities on a regular basis; operating companies and users must check their supply qualifications and product certification documents and keep records; increase the monitoring system for adverse events of medical devices, the re-evaluation system for registered medical devices, and the recall system for medical devices; the behavior of unauthorized production and operation without permission may be fined up to 20 times the value of the goods.

Production is production, and registration is registration.

Compared with the "Medical Device Supervision and Management Regulations" formulated in 2000, the new regulations revised this time have attracted more attention in the industry. The relationship between licensing and registration.

According to the 2000 version of the "Medical Device Supervision and Management Regulations", my country implements a product production registration system for medical devices. This registration system is divided according to the risk level of the medical devices produced by the enterprise. Simply put, the city-level drug supervision and administration department will issue a product production registration certificate for Class ** medical devices with lower risks, the provincial-level drug supervision and administration department will issue a product production registration certificate for Class ** medical devices, and the State Council’s drug supervision and administration department will issue a product production registration certificate for Class III medical devices with higher risks.