PPWR imposes on all companies placing packaging on the EU market a full chain of obligations spanning substances, design, and recyclability. Medical device companies are no bystanders — although, given the special nature of their products, the primary packaging in direct contact with the product enjoys certain relaxations with regard to "recyclability" and "recycled content," core responsibilities such as minimization, hazardous substances, labeling, EPR, and the Declaration of Conformity apply in full. There is therefore no such thing as a complete exemption for medical device packaging under the PPWR framework.

The previous section outlined the general process and basic compliance requirements for NMPA renewal registration, helping enterprises successfully complete applications under routine circumstances. However, in practice, many overseas medical device companies face not standardized renewal scenarios but complex special situations involving mandatory standard updates (e.g., GB 9706), dynamic product classification adjustments, conditional approval compliance, and changes in import agents. These scenarios often fall outside the scope of general procedures, and mishandling any single step may lead to rejection of the renewal application, certificate invalidation, or even product withdrawal from the market. Therefore, this section provides clear compliance solutions for six high-risk special scenarios.

Within China's medical device import compliance system, NMPA registration certificate renewal is a routine compliance task for overseas medical device manufacturers, yet it is also a core area where compliance errors and certificate invalidation most frequently occur. Compared to domestic enterprises, overseas manufacturers commonly face challenges such as delayed access to regulatory updates, differences between Chinese and foreign compliance systems, poor control over timing, inadequate awareness of standard updates, and unfamiliarity with the agent liaison process. Many overseas companies often miss the statutory six-month application window, confuse the order of change registration versus renewal, fail to promptly adapt to new standards like GB 9706, or mishandle classification adjustments. These issues prevent normal renewal, leading to certificate expiration and forcing a complete de novo registration process, consuming substantial time, resources, and compliance costs, and directly disrupting market access in China.

The medical device technical team of CIRS Group was invited to attend the event, and jointly held a special seminar on FDA & CE MDR Certification and NMPA Clinical Evaluation with the organizer. Empowering Chinese, Korean and global medical device enterprises to comply with regulations and expand overseas with professional regulatory services, CIRS Group has gained high attention and wide recognition from the industry.

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.

1 Whether the non-Chinese clinical trial data of the product must fully meet the requirements of the corresponding Chinese guidelines or not? 2 Can I select similar products as the control products according to Chinese regulations? 3 Is it necessary to include the Chinese trial data in the non-Chinese clinical trial data ? 4 Are the medical devices required to carry out clinical trials in China?

A single-group target value design can be considered when test device is technically mature and the disease for which it is intended is well understood, or when it is objectively infeasible to set up a control group We recommend choosing RCT trial design for clinical trial, according to technical development and clinical application status of intracranial drug-coated balloon dilatation catheter, which does not conform to the basic principle of single-group target value design.