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Shandong will explore the establishment of a management system for the commissioned production of medical devices
Release time:
2025-03-12 09:42
The Shandong Provincial Drug Administration recently issued the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in Shandong Province." The plan states that enterprises and research institutions located in Shandong Province can apply to become medical device registrants after obtaining a medical device registration certificate. They can then manufacture Class II and Class III medical devices themselves or entrust other enterprises with their production.
The implementation plan requires Shandong to explore the establishment of a management system for the entrusted production of medical devices, optimize resource allocation, and implement the responsibilities of the main body. Applicants for medical device registration can produce medical device samples themselves or entrust enterprises with production capabilities to do so. They will then submit an application to the drug administration department. If the sample is approved, they can obtain a medical device registration certificate and become a medical device registrant.
A relevant person in charge of the Shandong Provincial Drug Administration stated that after obtaining a medical device registration certificate, medical device registrants with the corresponding production qualifications and capabilities can manufacture products themselves or entrust production enterprises within the pilot area to do so. If entrusted production is chosen, and the entrusted production enterprise has production capabilities but lacks production licenses or other production qualifications, it must submit an application for a production license using the medical device registrant's medical device registration certificate before production can begin. Through this pilot program, Shandong will explore the establishment of a complete quality management system for medical device registrants, clarify the legal relationships between medical device registrants and entrusted parties, optimize the allocation of production resources, address issues such as resource waste, and build a quality management system and framework for the entire lifecycle of registrants.
The scope of medical devices produced under this plan includes Class II and Class III medical devices (including innovative medical devices) within the country. Medical devices listed in the catalog of prohibited entrusted production medical devices issued by the former State Food and Drug Administration are temporarily excluded from the scope of entrusted production under this plan.
Management system, production, medical devices, registration, entrustment, can, enterprise, registration certificate, self-obtained
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