On October 16, 2025, the Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs jointly issued the Shanghai Pilot Work Plan for Service Guidance on Temporary Import of Clinically Urgent Drugs and Medical Devices. 《上海市关于临床急需药械临时进口服务指导工作方案（试行）》This new plan aims to streamline the temporary import process for clinically urgent drugs and medical devices in Shanghai, helping patients gain faster access to innovative medical products.

Polycarbonate (PC), as a biodegradable polymer material, has various application scenarios in the medical field. These include disposable ophthalmic surgical knives, ophthalmic trocars/cannulas, polymer materials and products for dentures, orthopedic core drill, auxiliary instruments for vertebroplasty, and ring-handle syringes. As a raw material for medical device products, PC can undergo Master File registration. This authorizes medical device registration applicants to reference it as part of their regulatory submission when applying for medical device registration.

PPDO (Poly-p-dioxanone) is a class of aliphatic poly(ether-ester) polymers renowned for their excellent mechanical properties, biocompatibility, and biodegradability. As early as the last century, it was approved by the U.S. FDA for use in manufacturing Class III medical devices. It serves as a key material for producing absorbable sutures, cosmetic lifting threads, ligation clips, abdominal meshes for hernia repair, and other implantable devices. PPDO, along with its copolymers, blends, and composite materials, is also being developed for applications in bone repair, vascular stents, tissue adhesives, drug sustained-release carriers, and aesthetic products such as "ELLANSé" and "SCULPTRA".

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. The Medical Device Master File system facilitates the selection of raw materials and key components by medical device manufacturers and simplify the registration and application process. Simultaneously, the principle of voluntariness and confidentiality for the master file registration effectively protect the intellectual property rights of the master file owner.

The Medical Device Master File is a form of technical documentation submitted by its owner to the medical device technical review authority. It is used to authorize medical device registration applicants to reference it as part of their registration submission materials when applying for medical device registration. As a raw material for medical device products, recombinant collagen is eligible for master file registration.

In order to help Korean companies that want to export cosmetic medical devices to China, the Korea Medical Device Industry Association and CIRS Group Korea will hold a seminar on the Development Trends and Registration Process for Cosmetic Medical Devices in China.

Policy Interpretation – How to Enter the "Fast Track" of Priority Approval? ——This policy was implemented on January 1, 2017 1. Scope of priority approval Projects those are applicable to the priority approval of "fast track" a. Applications for registration of domestic Class III medical devices. b. Applications for registration of imported Class II and Class III medical devices. Projects those are not applicable to the "fast track" of Priority Approval a. Filing of Class I medical devices; b. Applications for registration renewal and registration change; c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices. 2. The conditions for applying for priority approval (1) Diagnose or treat rare diseases, with obvious clinical advantages. (2) Diagnose or treat malignant tumors, with obvious clinical advantages. (3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments. (4) Dedicated to children, with obvious clinical advantages. (5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China. (6) Medical devices listed in major national science and technology projects or national key research and development programs. (7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate. 3. When is the priority approval application submitted? Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.

For quantitative detection products, appropriate statistical analysis methods such as regression analysis should be selected according to the detection performance of the products for clinical trial results. Within a reasonable confidence interval, investigate whether there was a significant correlation and whether there is a significant statistical difference in the results of quantitative values. If possible, the recommendation should be taken into account that the possible differences in the performance of reagents in different sample concentration intervals, the overall concentration range is subject to interval stratified statistics, and the results in different concentration intervals were analyzed for correlation to better verify the correlation between the two reagents.

In order to prove the hemostatic mechanism of absorbable hemostatic products in China the applicant must submit technical or supporting data that can effectively prove or explain the principle of hemostatic action of the declared product. It must: clarify the hemostatic mechanism of the declared product in detail, describe how the product affects the hemostatic process, the advantages of the product in the hemostatic process, and confirm whether the application of this hemostatic mechanism combined with the declared product is scientific and reasonable. The applicant must review the domestic and foreign research literature supporting the hemostasis principle, and submit the original text and Chinese translation of the relevant scientific literature specifically supporting the hemostasis principle. The applicant must also clarify whether there are products applying the same hemostasis principle on the domestic and foreign markets, and also study whether the declared product may cause thrombosis, coagulation disorders, and other adverse reactions related to its use.

On September 18, 2020, the National Medical Products Administration issued the Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China No.104 of 2020. The purpose was to further implement the State Council's Opinions on Reforming the Review and Approval System for Pharmaceutical and Medical Devices and Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices. As well as to implement the reform of "streamlined administration and delegated power, improve regulations, and upgrade services" and the requirements for optimizing the business environment, comprehensively deepening the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs. This article explains the announcement which covers the production of products with an imported medical device registration certificate in China: