The authorities aim to establish an efficient and high-quality medical device registration examination and approval system by improving mechanisms, formalizing standards, improving efficiency and optimizing services.

Guangdong Medical Products Administration on May 23 introduced “Guangdong Medical Products Administration on Multiple Measures to Optimize Class II Medical Device Registration Examination and Approval”.

The main objectives are to further promote the reform of the examination and approval system, implement the comprehensive reform of drug supervision and promote the high-quality development of the medical device industry, said the press conference.

The first is to optimize and speed up the process. The technical and administrative examination period for product registration will be accelerated by more than 50% on average compared to the legal period.

The second is ranking and branching to improve efficiency. Expedited inspection, testing and technical review channels will be established to maximize handling efficiency.

Third, set up privileged access with professionals to provide services for products declared to be innovative in order to vigorously encourage companies to innovate.

The fourth is to simplify the approval process, encourage products imported and registered from other provinces to be transferred to Guangdong Province.

The fifth is to implement information management of the whole inspection process and adopt methods such as parallel inspection and collaborative inspection to improve inspection efficiency.

The last is to strengthen collaboration with the various departments to improve service levels. For example, the Guangdong Medical Products Administration helps qualified regions and provincial offices to jointly build industrial gas stations.

In the next step, Guangdong will further refine support programs and conduct performance evaluation of the whole process to ensure implementation, aiming to improve industrial competitiveness.