ISSUING AUTHORITIES:

Shanghai Stock Exchange

DATE OF ISSUANCE:

June 10, 2022

On June 10, 2022, the Shanghai Stock Exchange (SSE) issued the Guidelines of Shanghai Stock Exchange for the Application of the Rules for Issuance and Listing Review on the STAR Market No. 7 - Medical Device Companies under the Fifth Set of Listing Standards (hereinafter referred to as the “Guidelines No. 7”), to refine and clarify the application of such listing standards and support those medical device enterprises with “key and core technology” that have not yet generated a certain scale of income to issue and list on the Star Market.

STAR Market adopts five sets of listing standards with different requirements for market value, income and other factors. The fifth set features higher inclusiveness for innovative companies without a certain level of income.

The main content of the Guidelines No. 7 includes:

• First, the products with core technology shall fall within the fields encouraged and supported by the national strategy of sci-tech innovation in medical devices and relevant industrial policies, including equipment products and their key components, parts, accessories and basic materials in advanced inspection and testing, diagnosis, treatment, monitoring, life support, traditional Chinese medicine (TCM) diagnosis and treatment, implantation and intervention, and rehabilitation.

• Second, the specific requirements for achieving phased results are clarified. The applicant shall have at least one core technology product that has completed and passed product inspection and clinical evaluation in accordance with the relevant laws and regulations of medical devices, or have met other requirements for applying for medical device registration, with no major adverse areas that negatively affect the application registration and market registration for the product.

• Third, the applicant shall meet the requirement for having a large market space for the main business or products, and shall prudently forecast and disclose the details in meeting the standards based on certain criteria.

• Fourth, the applicant shall have obvious technological advantages in terms of the corresponding relationship between its core technologies and core products, measuring indicators, background and R&D achievements of the team, technological reserves, and ability of continuous R&D.

• Fifth, the applicant shall objectively and accurately disclose information and fully disclose relevant risks.

Reference:

《上海证券交易所科创板发行上市审核规则适用指引第7号——医疗器械企业适用第五套上市标准》