Starting August 2024, the Agency will process requests via RIMS, expand consultations for China's med device industry, and launch an NPRA pilot project.
Starting August 2024, the Agency for Medicines and Medical Devices will begin processing certain requests through the RIMS system. From August 5, this includes documentary quality control requests for drugs, and from August 12, it will expand to include various clinical trial-related requests, such as importing drugs for trials and reporting on clinical trials.
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To further support the development of China's medical device industry, Hebei, Shandong, and Hubei Medical Device Innovation Service Stations have been added as participating units for pre-registration technical consultations. These consultations will begin on August 12, 2024, offering high-quality guidance to local medical device manufacturers. Consultations will be held every Thursday, with specific times and locations provided by each service station.
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Learn more about China Medical Device Registration & Approval.
The NPRA is expanding its reliance approach to include new/additional indication applications through a 12-month pilot project starting on August 1, 2024. The project involves revised categories and criteria, as detailed in Appendix I. While NPRA aims to test new processes, they are also managing a high volume of variation applications with the same resources, making applicant cooperation crucial.
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Learn more about MDA Malaysia Medical Device Registration.
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