Shanghai Municipal Priority Approval Procedures for Class II Medical Devices

Article 1

With a view to meeting the clinical needs for medical devices, further optimizing the review and approval procedures for the medical devices in this Municipality, encouraging the R&D of medical devices oriented toward clinical value, and establishing a more scientific and efficient system for the review and approval of the medical devices, these Procedures are formulated in accordance with the rules, regulations 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 Measures for the Registration and Filing of Medical Devices, the Measures for the Registration and Filing of In Vitro Diagnostic Reagents, and the Priority Approval Procedures for Medical Devices.

Article 2

The priority approval procedures for Class II medical devices in this Municipality refer to the procedures where, upon the requests of the applicants, a special channel is established to prioritize the relevant review, approval, and other services during the registration application process for the medical device products that meet the conditions specified in Article 3 of these Procedures.

Article 3

Priority approval shall be implemented for the applications for the registration of Class II Medical Devices in this Municipality that meet one of the following conditions:

1. those included in the national major science and technology projects, key research and development programs, or the major science and technology projects and the science and technology innovation action plans of this Municipality;

2. those used for the diagnosis and treatment of rare diseases and with significant clinical advantages;

3. those used for the diagnosis and treatment of the diseases unique to or prevalent among the elderly, and there are currently no other effective diagnostic or therapeutic methods;

4. those exclusively used for children and with significant clinical advantages; or

5. those without identical products approved for registration within the Chinese mainland and with significant clinical advantages, or those with few identical products approved for registration within the Chinese mainland and such products cannot meet the clinical needs.

Article 4

For the medical device products that meet the conditions specified in Article 3 of these Procedures and require the application of the priority approval procedures, the applicants shall, when submitting the medical device registration applications, simultaneously file their applications for priority approval with Shanghai Municipal Medical Products Administration and submit the following materials:

1. Shanghai Municipal Application Form for Priority Approval of Class II Medical Devices (see Annex 1);

2. For the products that meet the conditions specified in Item 1, Article 3 of these Procedures, the applicants shall submit their explanations stating that the products are included in the national major science and technology projects, national key research and development programs, or the major science and technology projects and the science and technology innovation action plans of this Municipality, as well as the relevant supporting materials (such as project task books, research task books, etc.);

3. For the products that meet the conditions specified in Items 2 to 5, Article 3 of these Procedures, the applicants shall submit the relevant supporting documents including:

(1) for the medical devices used for the diagnosis and treatment of rare diseases with significant clinical advantages:

A. the incidence data of the product's indication and the relevant supporting materials, and the supporting materials proving that the indication is a rare disease;

B. a summary of the current status of clinical diagnosis for the indication; and

C. an explanation stating that the product has significant clinical advantages over the existing products or diagnostic methods, along with the relevant supporting materials.

(2) for the medical devices used for the diagnosis and treatment of diseases unique to or prevalent among the elderly, for which there are currently no effective diagnostic or therapeutic methods:

A. the supporting materials proving that the product's indication is a disease unique to or prevalent among the elderly;

B. a summary of the current status of clinical diagnosis for the indication; and

C. an explanation stating that there are currently no effective diagnostic or therapeutic methods for the indication, along with the relevant supporting materials.

(3) for the medical devices exclusively used for children with significant clinical advantages:

A. the supporting materials proving that the product's indication is a childhood disease;

B. a summary of the current status of clinical diagnosis for the indication; and

C. an explanation proving that the product is exclusively used for the diagnosis of childhood diseases and has significant clinical advantages over the existing products, along with the relevant supporting materials.

4. For the medical devices with no identical products approved for registration within the Chinese mainland and with significant clinical advantages, or for those with few identical products approved for registration within the Chinese mainland and such products cannot meet clinical needs:

(1) a summary of the current status of clinical diagnosis for the product's indication, together with reasons explaining its clinical advantages;

(2) the information on the approval and clinical use of the product and similar products both within and outside the Chinese mainland;

(3) an explanation of the search results proving that currently the product has no identical products approved for registration within the Chinese mainland and has significant clinical advantages, or that the product has few identical products approved for registration within the Chinese mainland and such products cannot meet clinical needs; and

(4) a self-declaration of the authenticity of the submitted materials.

Article 5

The acceptance department of Shanghai Municipal Medical Products Administration shall conduct a formal review of the application materials for priority approval.

For the registration application projects where the application materials for priority approval are complete and their applications are accepted, the department shall indicate that the applications are for priority approval and transfer the materials to Shanghai Municipal Medical Device and Cosmetics Evaluation and Inspection Center for verification and review.

Article 6

The applications for priority approval shall be reviewed within five working days from the date of acceptance, and the time required for expert demonstration shall be excluded from the calculation.

Article 7

For the applications proposed to be included in the priority approval procedures, the applicant, product name, acceptance number, and model/specification of the projects shall be publicly displayed on the official website of Shanghai Municipal Medical Products Administration, with the public notice period being no less than five working days. If no objection is raised during the public notice period, the projects shall be formally included in the priority approval procedures, and the applicants shall be informed.

Article 8

For any objection to a publicly displayed project, the objecting party shall submit a written opinion and explain the reasons within the public notice period (see Annex 2).

Shanghai Municipal Medical Products Administration shall, within 10 working days from the date of receiving the objection, study the relevant opinions and inform the applicant and the objecting party of its decisive opinions.

Article 9

Where an application is denied priority approval after review, Shanghai Municipal Medical Products Administration shall inform the applicant of the opinion on denying priority approval and the reasons therefor, and handle the matter in accordance with the regular approval procedures. This result shall not affect the regular approval procedures of the product.

Article 10

For the medical device registration applications included in the priority approval procedures, they shall be ranked separately in the order of receipt, and priority shall be given to technical review.

The technical review shall be completed within 40 working days. If the applicant is required to supplement and correct the materials during the technical review process, the technical review shall be completed within 30 working days from the date of receiving the supplemented and corrected materials.

Article 11

For the projects under priority approval, priority shall be given to the inspection of the quality management system for medical device registration.

The inspection of the registration quality management system shall be completed within 15 working days. If the applicant is required to make rectifications during the system inspection process, the system inspection shall be completed within 15 working days from the date of receiving the re-inspection application and the rectification report.

Article 12

For the projects under priority approval, Shanghai Municipal Medical Device and Cosmetics Evaluation and Inspection Center shall designate special persons to strengthen communication with the applicants.

Article 13

For the projects under priority approval, the status of "priority approval project" shall be indicated in the technical review reports. Shanghai Municipal Medical Products Administration shall give priority to the administrative approval of these projects and make approval decisions within 10 working days.

Article 14

For the medical devices that have obtained registration approval through the priority approval procedures, Shanghai Municipal Medical Products Administration shall give priority to the handling of their relevant production license applications.

Article 15

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