Notice 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 for Handling Matters Related to Transferring Production of Medical Devices with Registration Certificates to Shanghai,” which are hereby promulgated and will take effect on October 1, 2025.
This is hereby announced.
Regulations for 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 the registration of products that have imported or domestic medical device registration certificates (with valid registration certificates) 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 intended use/scope of application remain unchanged, and the medical device registration applicant transfers production from overseas or other provinces/municipalities to Shanghai (hereinafter referred to as “production transfer”), as well as the handling of medical device production licensing matters after obtaining the production transfer registration certificate.
The medical device registration applicant shall 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 shall 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”) 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 the “Pudong New Area Market Bureau”) shall be responsible for handling the production licensing of 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 that fall within the scope of these regulations for registering Class II medical device products, apply to the Municipal Medical Products Administration for initial registration.
Article 5 (Basic Documents) The registration applicant shall submit registration application materials in accordance with the format and catalog requirements of 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, 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
