The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The regulation will take effect on October 1, 2025. This marks a significant step in aligning Shanghai’s local regulatory framework with national policy, and in facilitating the localization of already registered medical devices.
Guangdong province has similar provisions. Click HERE for more information
For our comprehensive review on the Made-in-China policies, click HERE
Background
In 2020, NMPA released Announcement No. 104, which encouraged qualified registration holders of imported medical devices to shift production into China. This announcement simplified certain dossier requirements and served as an initial exploration into localization of imported devices.
Since 2024, both national and local authorities have issued a series of follow-up measures. At the national level, the State Council General Office Opinions on Deepening Drug and Medical Device Regulatory Reform to Promote High-Quality Development of the Pharmaceutical Industry (2024 No. 53), and NMPA Announcement No. 30 on optimizing matters related to localization of imported devices, provided clearer support. At the local level, the Shanghai Municipal Regulations on Drug and Medical Device Administration specifically required that holders of existing imported or domestic registration certificates who intend to transfer production into Shanghai must go through product registration and production licensing procedures.
Against this backdrop, and after extensive research and consultation, the Shanghai authority formulated the Provisions as a supporting regulation to the city’s Regulations.
Main Contents
The Provisions consist of five chapters and twenty articles, covering general principles, product registration requirements, production licensing requirements, consultation services, and supplementary clauses.
(1) Scope of Application
The scope follows the spirit of NMPA Announcement No. 30 and echoes Shanghai’s local regulations. The rules apply equally to both imported and domestic medical devices transferring into Shanghai production, ensuring fairness in market entry. Importantly, the original certificate holder and the applicant for transfer must share the same ultimate controlling entity.
(2) Registration Dossier and Quality System Review
The regulation integrates earlier national announcements with existing registration dossier requirements. Attachments provide detailed guidance to facilitate compliance.
For dossiers, applicants may reuse original submission materials such as summary reports, non-clinical data (with some exceptions), and clinical evaluation documents.
For quality system review, the authority will conduct checks following NMPA’s registration quality management procedures, with emphasis on the equivalence of design and development processes. Production quality systems will also be assessed under Good Manufacturing Practice requirements. Where conditions are met, inspections may be merged or reduced to avoid duplication.
(3) Consultation Services
A separate chapter sets out a consultation framework. This includes a dedicated hotline, encouragement for batch transfers, and pre-registration advisory services to improve review efficiency and enhance enterprise experience.
Key Explanations
(1) Clarification on Scope
Article 2 specifies that eligible products must fall under Class II of the current classification rules and catalog. Since classifications may change over time, applicants must demonstrate compliance with Class II requirements, and when necessary, seek an official classification determination.
The Provisions only apply to products with valid registration certificates. Expired or cancelled certificates are excluded. Moreover, only products whose name, structure, components, intended use, and key technical features remain essentially unchanged are eligible. For instance, a product with reduced model specifications, but otherwise unchanged in essential aspects, may still qualify.
(2) Registration Dossier Requirements
Article 5 requires applicants to submit dossiers in the formats defined by NMPA’s 2021 Announcements No. 121 and 122. Original materials may be reused for certain sections. However, product technical requirements and testing reports must demonstrate conformity to mandatory standards.
Applicants must also provide copies of the original certificate and any change records, along with a list identifying reused dossier content. The authority may request supplementary materials if safety, effectiveness, or quality control are not sufficiently demonstrated.
(3) Pre-Submission Services
Article 14 introduces pre-submission services as an optional form of communication. Applicants may seek guidance multiple times on the same transfer project before filing, in order to refine their dossiers. Once a formal submission is made via the online portal, the pre-service process ends. These services are advisory, not mandatory.
(4) Registration Certificate Notes
Article 19 states that approved transferred products will have their original registration certificate number indicated in the remarks section of the new certificate. Subsequent changes or renewals will follow standard procedures, and will no longer be tied to the original imported or out-of-province product documentation.
Takeaways for Overseas Manufacturers
The Provisions represent a concrete effort by Shanghai to implement national reform directions, streamline procedures, and encourage more efficient localization of medical devices. By clarifying dossier requirements, aligning inspection standards, and offering pre-submission consultation, the rules lower barriers for transferring products into local production while maintaining rigorous safety and quality oversight.
For manufacturers with products already registered in China, these measures create a clearer and more predictable pathway to shift production to Shanghai. This can help reduce costs, improve supply chain resilience, and bring production closer to the Chinese healthcare market.
At the same time, the emphasis on fairness between imported and domestic products signals Shanghai’s commitment to a transparent and equitable regulatory environment. The inclusion of advisory services also reflects a trend toward more service-oriented regulation, providing companies with practical support during the transfer process.
