Announcement on Regulations for Handling Matters Related to Transferring Production of Medical Devices with Registration Certificates to Shanghai
To implement the relevant requirements of the State Council’s opinions on comprehensively deepening the reform of drug and medical device regulation and promoting the high-quality development of the pharmaceutical industry, and to standardize the transfer of production of medical devices with registration certificates to Shanghai, the Shanghai Municipal Medical Products Administration has formulated the “Regulations on Handling Matters Related to Transferring Production of Medical Devices with Registration Certificates to Shanghai.” These regulations are hereby announced and will take effect on October 1, 2025.
Regulations on Handling Matters Related to Transferring Production of Medical Devices with Registration Certificates to Shanghai
Chapter 1: General Provisions
Article 1 (General Requirements) To implement the relevant requirements of the State Council’s opinions on comprehensively deepening the reform of drug and medical device regulation and promoting the high-quality development of the pharmaceutical industry, and to standardize the transfer of production of medical devices with registration certificates to Shanghai, these regulations are formulated in accordance with the “Regulations on the Supervision and Administration of Medical Devices,” the “Shanghai Municipal Regulations on Drugs and Medical Devices,” the “Measures for the Registration and Filing of Medical Devices,” the “Measures for the Registration and Filing of In Vitro Diagnostic Reagents,” the “Announcement of the National Medical Products Administration on Matters Related to the Production of Imported Medical Devices by Enterprises in China,” the “Announcement of the National Medical Products Administration on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Enterprises in China,” and the “Decision of the Shanghai Municipal People’s Government on Delegating a Batch of Administrative Approvals to Pudong New Area.”
Article 2 (Scope of Application) These regulations apply to products that have an imported or domestic medical device registration certificate (valid within the term) and fall under the category of Class II medical devices according to the current classification rules and catalog, where the product name, structure and composition/main components, and scope of application/intended use as stated in the registration certificate remain unchanged. This includes the registration for transferring production from overseas or other provinces/municipalities to Shanghai (hereinafter referred to as “production transfer”) by the medical device registration applicant, as well as matters related to obtaining a medical device production license after obtaining the production transfer registration certificate.
The medical device registration applicant should be an enterprise established by the medical device registrant for the production transfer or an enterprise under the same actual controller as the medical device registrant for the production transfer. The actual controller should comply with the relevant definitions and provisions of the “Company Law of the People’s Republic of China.” That is, the actual controller refers to a person who can actually control the company’s behavior through investment relationships, agreements, or other arrangements.
Article 3 (Division of Responsibilities) The Shanghai Municipal Medical Products Administration (hereinafter referred to as the “Municipal Medical Products Administration”) undertakes the functions of Class II medical device product registration and Class II and III medical device production licensing within its administrative area in accordance with statutory duties.
The Pudong New Area Market Supervision Administration (hereinafter referred to as the “Pudong New Area Market Bureau”) is responsible for handling production licenses for Class II and III medical devices where the production site is within Pudong New Area.
Chapter 2: Product Registration Requirements
Article 4 (Registration Application) For applications falling within the scope of these regulations for Class II medical device product registration, apply to the Municipal Medical Products Administration for initial registration.
Article 5 (Basic Documents) Registration applicants should submit registration application materials in the format and directory required by the “Announcement of the National Medical Products Administration on the Requirements for Medical Device Registration Application Materials and the Format of Approval Certificates” (No. 121 of 2021) and the “Announcement of the National Medical Products Administration on the Requirements for In Vitro Diagnostic Reagent Registration Application Materials and the Format of Approval Certificates” (No. 122 of 2021) (see Appendix 1 and Appendix 2).
Among these, copies of the original medical device registration certificate and its attachments, as well as copies of medical device change registration (filing) documents and their attachments, should be submitted. The overview documents, non-clinical data (except for the safety and performance essential principles checklist, product technical requirements, and test reports), and clinical evaluation data of the product can use the original medical device registration application materials. The product technical requirements and test reports should demonstrate that the product complies with applicable mandatory standards.
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