It was learned from the Beijing Food and Drug Administration that in light of the higher safety and risk status of aseptic and implantable medical devices, according to the unified requirements of the State Food and Drug Administration, Beijing has now started the sterile and implanted medical care within the city. Equipment inspection company special inspection work.

It is understood that this special inspection will focus on conducting on-site inspections of product management and quality management of equipment-incorporating enterprises including cardiac pacemakers, stents, artificial blood vessels, bone plates, and bone nails. For enterprises that have not operated for more than two years, they will reduce their corresponding business scope, and at the same time, they will cancel the “Medical Device Operation Enterprise License” by means of the cancellation of the notice for the enterprises that cannot be contacted during the inspection. Regarding the enterprises found to have violated laws and regulations during the inspection, the Beijing Food and Drug Administration stated that they will be severely punished in accordance with relevant regulations.

In May this year, the State Food and Drug Administration issued the "Circular on Strengthening the Supervision and Inspection of Manufacturers of Aseptic and Implantable Medical Devices." It called for organizations to carry out various forms of production of aseptic and implantable medical devices in their respective jurisdictions. Supervision and inspection of enterprises. In particular, it is also required that all regions track and inspect entrepreneurs this year not less than 20% of the number of aseptic and implantable medical device manufacturers in their respective jurisdictions. The number of enterprises under supervision and inspection shall not be less than 500.