Shanghai has released a new policy to streamline the process for localizing the production of already-marketed medical devices originally manufactured overseas.

The policy, structured into five chapters and twenty articles, clarifies requirements for product registration and manufacturing licensing, and strengthens consulting services.

It builds on the National Medical Products Administration's 2020 Announcement No 104 and subsequent 2024 guidelines aimed at optimizing the transfer of overseas manufacturing to domestic facilities.

It mainly applies to Class II medical devices with valid registration certificates, where the localized product maintains essential equivalence in product name, structure, composition, intended use, and technical requirements compared to the original imported version, and both the original registrant and the localization applicant have the same actual controller.

The policy aims to improve clarity and efficiency in the registration process. Applicants can now reuse existing registration data for product summaries, non-clinical data, and clinical evaluations, with exceptions for safety and performance principle lists, product technical requirements, and test reports.

Emphasis is placed on the substantial equivalence of domestic and overseas quality management systems, particularly in product design and development.

Furthermore, the policy offers specific guidelines for quality management system verification. Where requirements are met, registration and production quality system verifications may be reduced, waived, or combined.

Applicants must still submit original medical device registration certificates, including any change registration documents. The Shanghai Medical Products Administration retains the right to request additional supporting documentation if the initial submissions are deemed insufficient to guarantee product safety, effectiveness, and quality.

To assist companies, Shanghai is establishing a consultation hotline and encouraging batch localization. The policy introduces pre-submission services to address potential issues before formal registration.

However, these pre-submission services are not mandatory and will be terminated once a formal application is submitted through the "Government Online-Offline Shanghai" platform.

Once approved under the new regulations, the registration certificate for a localized product will reference the original medical device registration number.

Subsequent processes, such as change registration or renewal registration, will be handled according to standard regulations and will not be tied to the original imported product.