The National Medical Products Administration (NMPA) has released a notification on further adjusting and optimizing matters relating to the domestic production of imported medical devices by companies within China, effective immediately. This update aims to streamline the regulatory process and support the localization of production for imported medical devices.
Key Updates
The notification expands the definition of “foreign-invested enterprise” to include companies with the same actual controller as the registrant of imported medical devices, in addition to those directly established by the registrants. Submission requirements for filing materials have been adjusted to allow the use of original registration application materials for product review, non-clinical, and clinical evaluation purposes. If the registration applicant and the registrant of imported medical devices share the same actual controller, an explanation and supporting documents must be provided. Verification will focus on ensuring the substantial equivalence of quality management systems both domestically and internationally during the product design and development process.
Support for Innovative Products
The document explicitly supports changes in the production line for innovative products. For imported innovative medical devices, priority will be given to handling corresponding registration, production permits, and other matters. Products approved under the document’s requirements will follow legal and regulatory procedures for subsequent registration changes, extensions, and other matters, without being bound to the corresponding procedures for imported registered products.-Fineline Info & Tech
Leave a Reply