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 supervision 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,» which are hereby announced and will take effect from 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 supervision 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 with imported or domestic medical device registration certificates (valid within the term) that 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»), as well as matters related to obtaining a medical device production license after acquiring the production transfer registration certificate.
The medical device registration applicant shall be an enterprise established by the registrant of the transferred medical device or an enterprise under the same actual controller as the registrant of the transferred medical device. The actual controller shall comply with the relevant definitions and provisions of the «Company Law of the People’s Republic of China,» meaning the 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 «Municipal Administration») shall, in accordance with its statutory duties, undertake the functions of registering Class II medical device products and licensing the production of Class II and Class III medical devices within its administrative region.
The Pudong New Area Market Supervision Administration (hereinafter referred to as «Pudong New Area Administration») shall be responsible for handling production licenses for Class II and Class 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 registering Class II medical device products, apply to the Municipal Administration for initial registration.
Article 5 (Basic Documentation) Registration applicants shall 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 Documents» (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 Documents» (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, shall 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 may use the original medical device registration application materials. The product technical requirements and test reports shall demonstrate that the product complies with applicable mandatory standards.
Article 6 (Relationship Proof) If the registration applicant and the original medical device registrant are under the
