On June 20, Li Li, Secretary of the Party Group and Director of the State Food and Drug Administration, presided over a meeting to study and deploy measures to support the innovation and development of high-end medical devices, and deliberated and approved the "Measures on Optimizing the Whole Life Cycle Supervision to Support the Innovation and Development of High-end Medical Devices".

The State Food and Drug Administration positions innovative medical devices as a key area for the new quality productivity of medical devices, and the draft puts forward relevant support measures from various aspects such as review, registration, post-market supervision and going overseas, and innovative medical devices have good prospects for industrial development.

In the future, the industry is expected to achieve multi-dimensional development relying on enterprise technology platformization, AI diagnosis and treatment expansion, and consumer medical extension breakthroughs, and the industry will shift from scale expansion to a higher-level development stage, optimistic about the high-quality development of the industry and long-term investment opportunities.

|The "artifact" of medical care of the future

First of all, what is a high-end medical device? To put it simply, it is those high-tech products that can greatly improve the level of medical services, such as: medical robots: such as surgical robots and rehabilitation robots; High-end medical imaging equipment: CT machine, magnetic resonance machine (MRI), etc.; Artificial intelligence medical devices: tools that use AI for diagnosis and treatment; Novel biomaterial medical devices: Implants or prosthetic devices made using new materials.

These products not only allow doctors to treat patients more precisely, but also allow patients to enjoy better medical care.

The State Food and Drug Administration pointed out that the introduction of the "Measures" is of great significance, mainly the following points:

Promote major innovation: encourage the application of more new technologies, new materials, new processes and new methods in the field of healthcare; Meet the health needs: by improving the technical level of medical devices, we can better meet the growing health needs of the people; Implementation of the national strategy: This is an important step for the drug regulatory department to implement the decisions and deployments of the Party Central Committee and the State Council, aiming to promote the high-quality development of China's medical device industry.

This policy is to pave the way for the development of high-end medical devices, so that more high-tech products can enter hospitals and serve patients. The "Measures" put forward ten specific measures, each of which is like a shot in the arm for the high-end medical device industry

Fully support major innovations

As early as March 31, the State Food and Drug Administration published this draft for comments on its official website, inviting comments and suggestions from all walks of life. This document aims to fully support the innovative development of high-end medical devices through a series of measures.

The draft puts forward ten measures to support the innovation of high-end medical devices in the whole chain. Policies focus on the optimization of review and approval, the construction of standard systems and the strengthening of supervision: accelerate the launch of innovative products, implement innovative special reviews for domestic and internationally leading high-end medical devices, promote the review to move to the R&D stage, and explore the "conditional approval" mechanism in the fields of artificial intelligence and brain-computer interface, simplify the change and registration process of algorithm-optimized products, and strengthen the research of new biomaterials such as additive manufacturing materials and brain-computer interface electrodes.

All-round support from R&D to market:

Optimization of review and approval: For example, the implementation of innovative special review for domestic first-of-its-kind and internationally leading high-end medical devices means that these products can enjoy the "green channel" and obtain approval quickly;

Standard system construction: Promote standardization construction to ensure product quality, especially in emerging fields such as artificial intelligence and brain-computer interfaces, and explore "conditional approval" mechanisms to simplify processes;

Full life cycle supervision: not only pay attention to the pre-market approval of products, but also pay attention to post-market supervision, especially for high-risk products such as surgical robots and high-end imaging equipment, establish a "regulatory consultation" mechanism to monitor product quality and safety in real time;

Support enterprises to "go overseas": help powerful enterprises expand overseas markets, improve the export sales certification system, promote the application of international standards, and enhance international competitiveness.

The latest developments of listed companies

According to incomplete statistics from the "Science and Technology Innovation Board Daily", the listed companies have made progress in high-end medical devices this year:

United Imaging Healthcare's affiliates released "uInterv C550 Percutaneous Interventional Robot", which can perform surgery remotely under the guidance of CT dynamic real-time image, has obtained the Class III medical device registration certificate issued by the National Medical Products Administration.

Siangyu Medical said on the interactive platform that the portable exoskeleton mobility robot that the company focuses on has entered the stage of small batches, and is expected to obtain the medical device registration certificate and go on sale within the year. Previously, the company announced that it is expected that 7 robot products will obtain medical device registration certificates in 2025.

Sanyou Medical announced that the "superficial porous polyetheretherketone interbody fusion device" of its holding subsidiary passed the special review procedure for innovative medical devices of the Medical Device Technology Evaluation Center of the National Medical Products Administration.

On the whole, the "Measures on Optimizing the Whole Life Cycle Supervision to Support the Innovation and Development of High-end Medical Devices" (hereinafter referred to as the "Measures") is expected to accelerate the innovation and commercialization of domestic high-end medical devices.

At present, most of the high-end medical device market is still dominated by imported products, but with the support of policies and the progress of technology, there is a lot of room for domestic substitution: enterprises with strong R&D capabilities: those with strong R&D capabilities and large-scale production capacity will benefit; Enterprises with leading overseas strategies: companies that actively explore overseas markets will also occupy a favorable position; Tariff issues promote domestic substitution: Tariff issues will further promote the localization process of high-end medical devices, especially the independent controllability of upstream core components.

Several noteworthy segments include: high-end imaging equipment: such as MRI, CT, etc.; Surgical robots: can improve the accuracy and safety of surgery; Sequencers: for genetic testing and personalized medicine; Electrophysiology equipment: used for the diagnosis and treatment of cardiac diseases.