Special Review Procedures of Shanghai Municipality for Class II Innovative Medical Devices

Article 1

With a view to ensuring the safety and effectiveness of medical devices, encouraging the research and innovation of medical devices, promoting and applying new technologies for medical devices, and advancing the development of the medical device industry in this Municipality, these Procedures are formulated in accordance with the regulations, rules and normative documents including the Regulations on the Supervision and Administration of Medical Devices, the Regulations of Shanghai Municipality on the Administration of Drugs and Medical Devices, the Procedures for the Registration and Filing of Medical Devices, the Procedures for the Registration and Filing of In Vitro Diagnostic Reagents, and the Special Review Procedures for Innovative Medical Devices.

Article 2

The special review procedures for Class II innovative medical devices (hereinafter referred to as the "special review") refers to the special procedures, upon application by an applicant, for Class II medical device products that meet the conditions specified in Article 3 of these Procedures, which provides special channels and priority services for relevant testing, verification and inspection, technical evaluation, communication, and other matters before the submission of registration applications and during the review process.

Article 3

These Procedures apply to Class-II medical devices intended for registration in this Municipality that meet the following conditions:

1. The product's main working principle or mechanism of action is originally developed in China, with its performance or safety measures demonstrating fundamental improvement over similar products, and it possesses a leading-edge technological achievement in domestic market, and offers significant clinical value.

2. The applicant has completed the preliminary research on the product and obtained a basic finalized product with the research process being authentic and controlled, and the research data being complete and traceable.

3. The applicant, through his/her technological innovation activities, legally owns the invention patent rights for the core technology of the product in China; or has legally obtained the invention patent rights or the usage rights thereof in China through assignment, with the time not exceeding five years from the special review to the patent authorization announcement date; or the time the application for the invention patent of the core technology has been published by the competent patent administrative department of the State Council, and meanwhile the Intellectual Property Search and Consultation Center of China National Intellectual Property Administration has issued a retrieval report stating that the core technical solution of the product possesses novelty and inventiveness; or the product technology is domestically leading and can fill the gap in medical devices of this category in this Municipality.

Article 4

Shanghai Municipal Medical Products Administration and relevant technical institutions shall, in accordance with their respective responsibilities and the provisions of these Procedures, prioritize the processing of the application of innovative medical devices and strengthen communication with applicants, under the principles of early involvement, tailored policies for individual enterprises, coordinated research and review, and full-process guidance, without lowering the standards or reducing procedural requirements.

Article 5

Shanghai Municipal Medical Products Administration shall be responsible for specific work such as reviewing applications for special review, organizing expert reviews, and handling objections.

Article 6

Where an applicant meets the criteria specified in Article 3 of these Procedures and requires special review for innovative medical devices, he/she must submit an application for special  review to Shanghai Municipal Medical Products Administration before the initial registration of Class-II medical devices.

Article 7

The applicant shall log in to the Government Online-Offline Shanghai, select the online service "Application for Special Review for Class-II Innovative Medical Devices", fill out the online Application Form for the Special Review of Class-II Innovative Medical Devices, and submit materials as specified in Article 3 of these Procedures. The materials shall include:

1. Certification documents of the applicant's corporate qualifications.

2. The classification confirmation notice for the product to be managed as a Class-II medical device or other explanatory materials (if any).

3. Documents on the status of the product's intellectual property rights and supporting certificates (if any).

4. A summary of the product's R&D process and results.

5. Technical documents of the product, which shall include at least:

(1) The scope of application or intended use of the product;

(2) The working principle or mechanism of action of the product; and

(3) The main technical specifications of the product and the setting basis, the requirements for key raw materials and components, the main production process with flowcharts, and the testing methods for the main technical specifications.

6. Supporting documents for the product innovation, which shall include at least:

(1) Academic papers, monographs, and document summaries publicly published in core journals that fully demonstrate the clinical application value of the product;

(2) Analysis and comparison of the application status of similar products available in domestic and international markets (if any); and

(3) The innovation points of the product and content supporting its clinical value. For products that are original in China or technically leading in China, supporting materials such as clinical research data or clinical literature shall be provided as appropriate.

7. Risk analysis materials of the product.

8. Product Manual (Sample Version).

9. A self-certification on the authenticity of the submitted materials.

All application materials must be in Chinese. If the original documents are in a foreign language, a Chinese translation must be provided.

Article 8

Shanghai Municipal Medical Products Administration shall complete the formal review of the application materials for the special review within five working days, with focus on the content specified in Article 3 of these Procedures. Applications that meet the formal requirements stipulated in Article 7 of these Procedures shall be accepted, and an acceptance number shall be assigned. The format of the acceptance number is: SEI××××1 ×××2, where ××××1 represents the year of application, and ×××2 represents the product serial number.

For an accepted application for the special innovative review, the applicant may withdraw the application for the special review and the relevant materials before a review decision is made, and shall explain the reasons therefor.

Article 9

Where doubts exist regarding the regulatory classification of medical devices under the special review for innovation, Shanghai Municipal Medical Products Administration shall instruct the applicant to first submit a product classification application to the National Medical Products Administration.

Where the National Medical Products Administration, after review and confirmation, determines that the product shall be administrated as a Class II medical device, the applicant shall re-submit the application in accordance with these Procedures. The product's intended use and product description shall be consistent with the Product Classification Determination Notice.

Article 10

For an application for the special review submitted by an applicant, Shanghai Municipal Medical Products Administration shall organize experts to conduct the examination through joint meetings, correspondence reviews, or other methods. Shanghai Municipal Medical Products Administration may refrain from organizing experts to conduct the examination if the application materials fall into any of the following circumstances:

1. The application materials are false.

2. The application materials contain conflicting or inconsistent information.

3. The application materials contain content that is inconsistent with the declared project.

4. The application materials contain incomplete intellectual property certificates or unclear patent rights.

5. Where the prior review has explicitly stated that the product's primary working principle or mechanism of action is not originally developed in China, and the product design remains unchanged upon reapplication.

Article 11

For an application project that is proposed to be approved for inclusion in the special review after examination, upon verification and approval by Shanghai Municipal Medical Products Administration, information such as the applicant and product name shall be publicly announced on the Administration's official government website. The public announcement period shall be no less than 10 working days.

Any party with an objection to the content of the public announcement shall submit a written opinion and explain the reasons within the public announcement period. After the public announcement period ends, Shanghai Municipal Medical Products Administration shall study the relevant opinions and make a final review decision.

Article 12

Shanghai Municipal Medical Products Administration shall, within 60 working days from the date of receiving the application, make a review decision and notify the applicant of the result, excluding the public announcement period and the time for handling objections.

After review, for application projects that are not approved for the special review, Shanghai Municipal Medical Products Administration shall notify the applicant of the review opinions and reasons; this result shall not affect the applicant's application for the registration of the Class II medical device in accordance with the normal procedures.

For Class II innovative medical devices that are approved to be reviewed in accordance with these Procedures after review, if the applicant fails to file an application for medical device registration within five years from the date of being notified of the review result, the special review shall no longer be implemented in accordance with these Procedures. The applicant may reapply for the special review in accordance with these Procedures after five years.

Article 13

For Class II innovative medical devices, Shanghai Municipal Medical Products Administration and relevant technical institutions shall make priority arrangement for inspections, strengthen technical services and guidance, and give priority to issuing inspection reports.

Article 14

For Class II innovative medical devices, before the acceptance of the product registration application and during the technical review process, Shanghai Municipal Medical Products Administration shall assign dedicated personnel to provide early involvement services. These personnel shall conduct timely communication and provide full-process guidance in such links as clinical evaluation, performance verification, and registration process inspection. Records shall be made of the communications and exchanges, which shall serve as references for the subsequent product research and review work.

Article 15

For the registration applications of Class II innovative medical devices, Shanghai Municipal Medical Products Administration shall grant priority acceptance, priority review, priority process inspections, and priority approval. For the changing of registration applications of Class II innovative medical devices that have been approved for registration, relevant technical services shall be provided with reference to Articles 13 and 14 of these Procedures, and priority processing shall be granted to such applications.

The technical review shall be completed within 20 working days, and the administrative approval shall be completed within five working days.

Article 16

Shanghai Municipal Medical Products Administration may terminate these Procedures and notify the applicant if any one of the following circumstances applies:

1. The applicant voluntarily requests termination;

2. The applicant fails to fulfill the corresponding obligations in accordance with the specified time and requirements;

3. The applicant provides forged or false materials;

4. All applications for invention patents related to the core technology of the product are rejected or deemed withdrawn;

5. The applicant loses the patent rights or the right to use all invention patents related to the core technology of the product;

6. Upon review, it is found that the product applied for is not administrated as a Class II medical device; or

7. Upon discussion at the expert review meeting, it is determined that the product is no longer appropriate to be administrated in accordance with these Procedures.

Article 17

During the implementation of these Procedures, Shanghai Municipal Medical Products Administration shall strengthen communication and coordination with relevant departments, so as to keep updated with the R&D progress of innovative medical devices.

Article 18

Where a significant change is required for the research work of a Class II innovative medical device—such as revision of the clinical trial protocol, adjustment to the method of use, specifications and models, intended use, scope of application, or targeted crowds—the applicant shall assess the impact of the change on the safety, effectiveness, and quality control of the medical device. If there is a change to the main working principle or mechanism of action of the product, the applicant shall re-submit an application in accordance with these Procedures.

Article 19

For the Category-II innovative medical devices where these Procedures do not provide specific registration provisions, the relevant provisions of the Procedures for the Registration and Filing of Medical Devices and the Procedures for the Registration and Filing of In Vitro Diagnostic Reagents shall apply.

Article 20

Innovative medical device holders shall conduct post-marketing adverse event monitoring and re-evaluation of the said devices in accordance with law.

Article 21

These Procedures shall be effective as of September 1, 2025, and shall remain valid for five years, until August 31, 2030.