上海：对在研重点医疗器械提供注册体系核查预审服务

Core Insights - The Shanghai government has issued measures to enhance the regulatory framework for pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry [1] Regulatory Reforms - The measures include improving the review and approval mechanisms for drug and medical device registrations [1] - There will be pre-guidance for key products under research before registration applications, with a focus on provincial-level review and approval matters [1] - The implementation of pre-inspection and immediate review processes, along with smart review guidelines, is emphasized [1] Prioritization of Key Products - Key drugs under research and imported drugs transitioning to local production will receive priority for registration sampling and inspections [1] - Simultaneous registration verification and compliance checks for production quality management will be conducted [1] - For key medical devices under research, a pre-review service for the registration system will be provided, along with prioritized inspection [1] Support for New Enterprises - New medical device manufacturing companies that have passed on-site verification of the product registration system at the same production address, without authenticity issues or serious defects, may be exempt from on-site production license inspections [1]