The authorities are aimed to build an efficient and high-quality medical device registration review and approval system by improving mechanisms, formalizing standards, enhancing efficiency, and optimizing services.
Guangdong Medical Products Administration introduced the "Guangdong Medical Products Administration on Several Measures For Optimizing the Review and Approval of Class II Medical Device Registration" on May 23.
The main purposes are to further promote the reform of the review and approval system, to implement the comprehensive reform of drug supervision, and to promote the high-quality development of the medical device industry, stated the press conference.
The first is to optimize and speed up the process. The time limit for technical and administrative review of product registration will be accelerated by an average of more than 50% compared with the statutory time limit.
The second is grading and branching to improve efficiency. The fast-track channels in inspection, testing and technical review will be established to maximize handling efficiency.
Thirdly, set special accesses with professionals to provide services for products that are declared to be innovative to vigorously encourage enterprises to innovate.
The fourth is to simplify the approval process, encourage imported and registered products from other provinces to be transferred to Guangdong Province.
The fifth is to implement the information management of the whole process of inspection, and adopt methods such as parallel inspection and collaborative inspection to improve the inspection efficiency.
The last is to strengthen collaboration with different departments to improve service levels. For example, the Guangdong Medical Products Administration supports qualified regions and provincial bureaus to jointly build industrial service stations.
In the next step, Guangdong will further refine the supporting progrmmes and carry out the performance evaluation of the whole process to ensure the implementation, with the aim of enhancing industrial competitiveness.