Policy Interpretation of the “Shanghai Second – class Medical Device Priority Approval Procedures”

In order to continue to do a good job in the priority approval of Class II medical devices in Shanghai, based on the content of the original “Shanghai Class II Medical Device Priority Approval Procedure” and in combination with the relevant regulations, rules and normative documents such as the new “Regulations on the Supervision and Administration of Medical Devices”, “Shanghai Regulations on the Administration of Drugs and Medical Devices”, “Management Measures for the Registration and Filing of Medical Devices”, “Management Measures for the Registration and Filing of In Vitro Diagnostic Reagents”, and “Medical Device Priority Approval Procedure”, the Shanghai Medical Products Administration has formulated the “Shanghai Class II Medical Device Priority Approval Procedure”, which is now announced.

Ⅰ. Background and Process of Formulation

In order to implement the State Council’s “Opinions on Reforming the Evaluation and Approval System for Drugs and Medical Devices” and further improve the efficiency of the evaluation and approval of Class II medical devices in this city, the former Shanghai Food and Drug Administration issued the “Shanghai Class II Medical Device Priority Approval Procedure” on July 26, 2017 based on the “Medical Device Priority Approval Procedure” (2016 No. 168) issued by the former State Food and Drug Administration. In 2019, the Shanghai Drug Administration initiated the revision of the above procedures and officially released the revised “Shanghai Second Class Medical Device Priority Approval Procedure” (Shanghai Drug Administration Regulation [2020] No. 1) in January 2020.Since the implementation of the “Shanghai Second Class Medical Device Priority Approval Procedure” in 2020, 11 products that have been included in national science and technology major projects, key research and development plans, or major science and technology projects and innovation action plans in the city have been approved for priority approval. With the successive release of the revised “Regulations on the Supervision and Administration of Medical Devices” and supporting regulations in 2021, the priority registration procedure has been officially included as one of the special registration procedures in the “Measures for the Administration of Registration and Filing of Medical Devices” and the “Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents”.In order to better serve the strategic goal of building a globally influential science and technology innovation center in this city and continue to do a good job in the second-class priority approval work in this city, the Shanghai Drug Administration has launched the development of the “Shanghai Second Class Medical Device Priority Approval Procedure” in accordance with the requirements of the “Shanghai Drug and Medical Device Management Regulations”.

Ⅱ.Comparison of the main content with the changes in the original program

The “Shanghai Second-Class Medical Device Priority Approval Procedures” (hereinafter referred to as the “Priority Approval Procedures”) consists of 15 articles. Following the principles of clear processes, well-defined responsibilities, and scientific supervision, it clarifies aspects such as the definition of the “Priority Approval Procedures”, eligible conditions, requirements for submitted materials, review procedures, announcement processes, handling of objections, and priority measures. Compared with the original procedures, the main changes are as follows:

i.Timely update the basis of regulatory documents for formulating the “Priority Approval Procedures”

In 2021, the State Council issued the newly revised “Regulations on the Supervision and Administration of Medical Devices”. Subsequently, the National Market Regulatory Administration issued supporting regulations, namely the “Measures for the Administration of Medical Device Registration and Filing” and the “Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing”, further clarifying the legal status and requirements of the priority registration procedures.

ii.Make good connections with the Regulations on the Administration of Drugs and Medical Devices in Shanghai

Add the provision “Situations for applying for the priority registration procedure include ‘there is no domestically registered product of the same variety and there is a significant clinical advantage, as well as there are few domestically approved registered products of the same variety and they cannot meet the clinical needs'” to Article 19 of the “Regulations on the Administration of Drugs and Medical Devices in Shanghai Municipality”. Write this into Article 3 (5) and Article 4 (3) of the “Priority Approval Procedure”, clarify the specific requirements for declaration materials, further expand the scope of application of the priority approval procedure, and accelerate the market launch of products.

iii. Continuously improve the priority measures of the “Priority Approval Procedures”

The “Priority Approval Procedures” focuses on the registration review and approval work, shortening the technical approval time limit from the original 45 working days to 40 working days. On the premise of not lowering the standards and not reducing the procedures, following the principles of safety, effectiveness, rapidity, efficiency, and scientific approval, it conducts priority technical reviews, priority system verifications, and priority administrative approvals for product registration applications, further improving work quality and efficiency and enhancing the sense of experience of enterprises.

iv. Combine with the electronic declaration system and adjust the requirements for data submission.

In order to achieve full online acceptance of medical device registration and electronic review and approval in this city, since January 1, 2023, the Shanghai Municipal Drug Administration has officially implemented the Medical Device Registration Electronic Declaration System (eRPS system), and the “Priority Review and Approval Procedure” has been incorporated into the eRPS system. The relevant requirements for submitting materials have been adjusted simultaneously in the formulation of this procedure.

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Source: Shanghai Municipal Drug Administration

Translated & edited:  Bradyknown