Director of the State Food and Drug Administration: The medical equipment enterprise is not enough for the flight inspection, it will be doubled!

On September 10th, the medical network increased the number of medical equipment flight inspections. In 2018, the 100 missions of the flight inspections have been completed more than half. Since 2019, the number of inspections will be increased to 200, and the number of inspections for medical equipment enterprises will be doubled to 300. Home, 400 homes.

Recently, a director of the State Food and Drug Administration said in public that the number of 100 medical device companies in the 2018 flight inspection is not enough. In the future, the number of flight inspections should be increased. .

According to the Director, since 2018, the State Food and Drug Administration has carried out six key tasks in the supervision of medical devices, including strict prevention and strict control of medical device safety risks, strengthening on-site inspection work, and grasping sampling and problem handling. Work and strengthen medical device supervision Regulation Construction, etc.

Especially in the fight against unlicensed operation and operation of unlicensed medical devices, this year's special action plan listed unlicensed production as a key target. Some production companies, product registration certificates have not yet started to start production, ignoring safety production. Specification, was discontinued and rectified.

In addition, the Director also mentioned that many production companies have not had problems for many years, but when they change suppliers, they are found to have problems, saving money for purchases and reducing them. product quality This reminds the production company to pay attention to suppliers and procurement links.

At present, since January 2018, the official website of the State Food and Drug Administration has been notified by flying inspections almost every month, and the number of notifications has remained at around 10. The director disclosed that the domestic medical equipment enterprises in 2018 The number of flight inspections is 100, and 62 have been completed, 12 of which have been discontinued for rectification.proxy ) medical instruments enterprise The number of flight inspections is 26. In the overseas inspection of medical equipment, the products that have not been recalled for the recall will be included in the flight inspection, and they will be investigated together.

Another important point is that from June 25 to July 24 this year, the Ministry of Justice publicly solicited opinions on the amendments to the current Regulations on the Supervision and Administration of Medical Devices. The latest news is that the relevant personnel of the Legal Affairs Department of the State Food and Drug Administration said that The Medical Device Supervision and Administration Regulations (Amendment) is intended to be introduced in 2019.

As the parent law of the industry, the Regulations on the Supervision and Administration of Medical Devices have been increased by 12, two were deleted, and 39 were revised. The changes were relatively large. Thus, the supervision and management methods for production, operation, and use links may be revised. .

At the same time, some insiders said that the "Amendment" is learning from the experience of the United States.

In the United States, more than 50% are low-risk, only one type of medical device is generally controlled, the number of clinical exemptions is 780; 40% of the second-class medical devices, the number of exemptions is more than 60; the most need to do clinical high Risk of three types of equipment, only 7%.

The proportion of China's three types of medical devices is 20% to 30%, and there are more clinical trials required. Therefore, we need to make changes to the medical device regulations, consider how to solve them scientifically, and improve the efficiency of clinical trials.

The FDA is worth learning: Based on the patient-centered principle, the FDA has shortened its time to market, but in order to ensure quality, its follow-up regulatory measures are very strict.

The Director stated that according to the above Amendment, the next step will be to revise the methods of quality control and management of medical device production, operation and use.

And the formulation of the "Administrative Measures for the Supervision and Administration of Imported Medical Device Agents". For illegal enterprises, both the licensee and the agent are punishable. This method has been announced on the official website of the State Food and Drug Administration.