Qinzhou releases 1st batch of medical device registrations, production licenses
The Qinzhou Port area of the Guangxi Pilot Free Trade Zone (FTZ) released the first batch of medical device registrations and production licenses to four companies.
These four companies include Guangxi Kaier Medical Technology, Baisheng Medical, Guangxi Xianjian Biotechnology and Guangxi Innovation Medical Equipment. They are the first batch of medical device registrations and production licenses independently approved and issued by the Qinzhou Port area of the Guangxi FTZ after taking over autonomous region-level administrative power.
"For the Class II medical device products that our company applied for, it took only around two months from submitting the application to obtaining the registration certificate. In the past, or in other places, it may take a year or more to complete. From product inspection to data declaration, system assessment, and technical review, the entire process is guided by the area department," according to the person in charge of Guangxi Innovation Medical Equipment.
The administrative examination and approval bureau of the Qinzhou Port area of the Guangxi FTZ has transformed from handling administrative duties to providing optimized services to help enterprises develop.
Up to now, the Qinzhou Port area of the Guangxi FTZ has approved seven Class II medical device registration certificates that cover diagnosis, rehabilitation, auxiliary treatment and other fields.
The Qinzhou Port area of the Guangxi FTZ will deepen the review and approval reform process, innovate the working mechanism, optimize the approval process, improve the efficiency of government services, and promote the high-quality development of the biomedical industry.
The Qinzhou Port area of the Guangxi FTZ releases the first batch of medical device registrations and production licenses. [Photo/WeChat account: gh_df8bc987e060]