Thank you to the Evaluation Center of the Provincial Food and Drug Administration to help our company quickly change its product registration certificate.

As a new company after the existence and separation of Timerein (Changzhou) Medical Devices Co., Ltd., Changzhou Timerein Biotechnology Co., Ltd. needs to divide the original company's assets into Class III medical device products (Disposable Sterile Injection Needle) and Class II medical device products (Disposable Sterile Roller Needle) The rights are transferred to the new company. This matter is complicated and time-consuming, involving multi-level and multi-departments such as national bureaus, provincial bureaus and sub-bureaus, and sub-centers. The key is that there is no experience to learn from the relevant changes to the registration certificate after the existence of separation. After the relevant leaders of the Provincial Bureau, Changzhou Inspection Branch and Sub-center learned about this, they immediately arranged someone to provide us with policy advice, took the trouble to carry out guidance, and actively helped coordinate various resources, and even gave up weekend rest days to the enterprise for on-site physical examination, and finally helped our enterprise in just two months. The transfer of the two product registration certificates of the new company, the application of the production license and the addition of the new production address of West Taihu Lake have been completed. After the completion of this matter, the change of the production address and registrant's residence on the two product registration certificates was completed in just one week.

The existence and division of changing the Class II and Class III registration certificate, applying for and changing the production license and the new production address is the first high-frequency change in Jiangsu Province, and it is rare in the country. In the whole process of applying for change, the Administrative Examination and Approval Office of the Provincial Food and Drug Administration, the Medical Device Production Supervision Office, the Evaluation Center, the Audit and Inspection Center, and the Changzhou Branch and Sub-center are urgent for enterprises. They actively provide us with policy consultation and business guidance, issue certificates in a timely manner, speed up the review and approval progress, and be faster and more efficient. Helping enterprises to realize the timely conversion of production after existence and division has minimized the impact of our company on the production and sales of enterprises in the stage of license change. Let enterprises deeply feel the "supervision and unlimited service"!