Innovative medical devices welcome major benefits again! Qualified for direct admission to the hospital

In recent years, the government has issued a series of policies to encourage and promote the development of innovative medical devices and consumables. However, due to the fact that most innovative medical devices and consumables are not covered by medical healthcare security, it still brings many difficulties to the development of innovative products.

Therefore, in order to accelerate the promotion and application of innovative products, the Shanghai Municipal Commission of Economy and Information Technology and other departments issued the “Special Action for Promoting Large Scale equipment Updating and Expanding the Application of Innovative Products in the Industrial Sector in Shanghai” (hereinafter referred to as the Special Action) on May 31, 2024.

This also means that this round of medical equipment updates will further benefit the admission of innovative medical devices, especially medical imaging, radiation therapy, remote diagnosis and treatment, surgical robots and other medical equipment.

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Innovative medical devices will be included in medical healthcare security payments

After the launch of innovative medical devices, under the influence of current medical healthcare security cost control and other practical factors, some hospitals have a lower willingness to adopt innovative devices with higher prices. The lack of market acceptance will directly affect the commercialization effect of the product, thereby weakening the investment return rate of innovative medical devices.

In this regard, the National Medical Healthcare security Administration is studying and improving the online listing mechanism of the centralized procurement platform for pharmaceuticals, and promoting the establishment of a unified national online listing and transaction rules.

In recent years, the support for innovative medical devices in Shanghai’s medical healthcare security and centralized procurement has also been continuously increasing.

There are preferential policies given by the Shanghai Medical Healthcare security Bureau:

• Except for nationally negotiated drugs and centralised band purchasing of medicines and devices, other medicines and devices are independently bargained by enterprises and medical institutions.
• – During the trial period of the optimized new project, medical institutions are encouraged to accelerate the implementation of their own pricing mechanism.
• In terms of DRG/DIP payment, innovative pharmaceutical devices are prioritized, and payment standards for new technology application cases are raised. There is no control ratio for high rate cases of new technology application, and large-scale new technology applications can be independently grouped.
• Steadily expanding the scope of medical service projects and medical consumables healthcare security payments in this city, prioritizing the coverage of innovative drugs and devices.

According to the 2023 list of innovative medical device application demonstration projects released by the Shanghai Municipal Commission of Economy and Information Technology, a total of 69 innovative medical devices have been included in the list of application demonstration projects. Among them, medical imaging devices have received special attention, and a total of 14 projects have been selected, ranking first.

At the same time, the Special Action proposes that enterprises can directly apply for online procurement of products that have obtained national medical healthcare security consumables codes and meet the management regulations of the city’s separately chargeable consumables catalog.

According to the 2019 list of consumables that can be charged separately in Shanghai and the newly added products from 2023 to 2024, it can be seen that vascular intervention surgical equipment, artificial organs, nerve stimulators and accessories are the key product categories that Shanghai focuses on. Among them, 38 products of vascular intervention surgical equipment were selected, ranking first.

It is foreseeable that this policy will further shorten the time for innovative medical devices to enter the market, greatly benefiting the development of related innovative medical device enterprises.

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Innovating medical devices to accelerate the pace of admission to hospitals in Shanghai

Policy driven rapid growth in the scale of innovative medical device industry

In order to ensure the smooth commercialization of innovative medical devices and accelerate the pace of admission, on July 28, 2023, Shanghai further stipulated that the assessment mechanism of medical institutions should be adjusted and optimized, and hospitals should not restrict the admission of innovative medical devices based on the number of drug catalogs, the proportion of drugs/consumption, and other reasons.

At the same time, the Special Action also proposes more relevant preferential policies: medical device products included in the recommended catalog of innovative products in this city can be directly admitted for use according to regulations.

In 2023, the Shanghai Municipal Commission of Economy and Information Technology released the first and second batches of the 2023 Shanghai Innovative Product Recommendation Catalogue，ith a total of 48 products from 20 major categories selected.

As of now, according to data from   Joinchain mathematics

, a total of 43 innovative medical devices have been approved for market in Shanghai, including 39 national level projects and 4 provincial level projects. Among them, there are a large number of passive implantable devices, medical software, and medical imaging devices. Passive implant devices mainly include cardiovascular and cerebrovascular implant products such as aortic stents and drug balloons.

In the future, Shanghai will also release a supply list of over 20 key innovative medical equipment products, encouraging qualified medical institutions to accelerate the updating and transformation of medical equipment such as medical imaging, radiation therapy, remote diagnosis and treatment, and surgical robots.

According to Joinchain’s data, with the support of a series of national and Shanghai related policies such as “trade in”, the demand for high-end medical equipment such as medical imaging, medical endoscopes, and surgical robots has rapidly rebounded after the end of the epidemic, and the market size has rapidly expanded in recent years.

Among them, the annual compound growth rate of the CT market size in Shanghai is as high as 114.09%, and the annual compound growth rate of the surgical robot market size is as high as 43%. The market size of endoscopes and MRI is also steadily growing.

At present, both national and local medical healthcare security bureaus have clearly stated that innovative medical devices will be included in medical healthcare security payments, opening up a green channel for entering hospitals.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Joinchain

Translated & edited： Bradyknow