SSE Publishes Guidelines for Application of 5th Set of Listing Standards on Medical Device Companies on STAR Market

10 Jun 2022

The Shanghai Stock Exchange (SSE) published and implemented on June 10 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), intended to further support the high-level self-reliance and self-improvement in science and technology, and encourage medical device enterprises to carry out research, development and innovation in key and core technologies and products.

The fifth set of listing standards for the STAR Market features higher inclusiveness for companies with “key and core technology”, which supports the companies in the research and development stage not yet generating a certain level of income for going public. Since the launch of the board, a number of innovative drug R&D companies have been successfully listed on the STAR Market through the fifth set of listing standards, triggering a clustering and demonstration effect for drug R&D companies. Formulated by the SSE under the guidance of the China Securities Regulatory Commission (CSRC), the Guidelines further clarify the circumstances and requirements for the fifth set of listing standards to apply to medical device companies, which is an important step to further improve the mechanism of the STAR Market for supporting the listing of medical device enterprises with “key and core technology”, and will give better play to the role of the STAR Market in serving the development strategy of sci-tech innovation.

Based on earlier review practice as well as the developments of sci-tech innovation and the industry regulatory requirements in the field of medical devices, the Guidelines provide the medical device companies applying under the fifth set of listing standards for the STAR Market with detailed rules on the scope of the products with core technology, phased results, market space, technological advantages, business sustainability, and information disclosure. The main content includes: First, the scope of the products with core technology is specified. The products with core technology of the applicant shall fall in the fields encouraged and supported by the national strategy of sci-tech innovation in medical devices and relevant industrial policies. Among those, mainly, are 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, attention is given to the demonstration of market space. 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 the innovativeness, R&D progress, advantages and disadvantages against competing products, clinical needs and market situation for the product with core technology. Fourth, obvious technological advantages are required. The applicant shall have obvious technological advantages, and shall disclose whether they have obvious technological advantages in terms of the corresponding relationship between its core technologies and core products, indicators measuring the level of the core technology, background and R&D achievements of the team, technological reserves, and ability of continuous R&D. Fifth, requirements for information disclosure and verification are put forward. The applicant shall objectively and accurately disclose information such as the core technology products and their level of advancement, research and development progress and phased results, approval and registration status, expected market space, and commercialization arrangements for future production and sales, and fully disclose relevant risks. In addition, the intermediary agencies shall effectively inspect and check the corresponding content.

Going forward, under the leadership of the CSRC, the SSE will actively guide qualified medical device companies in applying to go public on the STAR Market under the fifth set of listing standards, continuously improve the mechanism for supporting the listing of the companies with “key and core technology” on the STAR Market, and further propel the high-quality development of the STAR Market.

Attachment: Notice of Publishing 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