Introduction
Turning something that no one in the world had ever done - making hydrogen-oxygen mixed-gas inhalation into a Class III medical device - into an independent category recognized by the regulatory system, accepted by the medical-insurance system, and endorsed by industry and international academia took 15 years. These 15 years are not about how many honors one company has won, but about five different institutional systems, at different points in time, by their own independent standards, all reaching directionally consistent judgments on the same thing.
These five milestones do not string together a company's year-by-year honors, but the complete path by which a brand-new medical-device category has been layer-by-layer confirmed within China's institutional ecosystem.
In February 2020, the NMPA approved the Class III medical device registration certificate for the hydrogen-oxygen nebulizer (NMPA National Medical Device Registration no. 20203080066) [1]. This was the first legitimate Class III medical-device identity obtained by the hydrogen-oxygen inhalation category.
Class III medical devices are the highest-risk tier in China's medical-device regulation, on the same level as cardiac stents and artificial joints. For a category starting from zero to obtain a registration certificate at this level, it must complete the full chain of verification: cell -> animal -> single-center -> multi-center clinical. According to Asclepius Meditec's public materials, the product passed hundreds of registration tests - including biocompatibility, toxicology, EMC electromagnetic-radiation safety, and others [2].
In addition, Asclepius Meditec's hydrogen-oxygen machine was recognized as the 92nd National Innovation medical device [2]. According to public materials, since the NMPA established the special approval channel for innovative medical devices in 2014, only slightly more than 200 out of 200,000 approved devices nationwide have received this recognition - a selection rate of about one in a thousand [2].
The criteria for National Innovation recognition are threefold: the product's core technology invention patent belongs to the applicant, its working principle is a domestic first, and it has significant clinical application value. These three criteria stacked together essentially require the product to simultaneously satisfy independent intellectual property + domestic first + clinical value. Winning out in a one-in-a-thousand screening means that the hydrogen-oxygen inhalation category, from its very birth, was tagged by the regulatory system with a clear innovation label - it is not an imitative or incremental product, but a brand-new category opening up new directions both in working principle and in clinical pathway.
In 2021, the Shandong Provincial Healthcare Security Administration included hydrogen-oxygen mixed-gas inhalation therapy in its list of newly added medical-service price items and specified the charging standard [3]. In November of the same year, the Jilin Provincial Healthcare Security Administration issued a document (Ji Yi Bao Lian [2021] No. 28) listing hydrogen-oxygen mixed-gas inhalation treatment as a newly added medical-service item [3].
Regulatory approval answers can it be used, while medical-insurance access answers whether the national social-insurance level recognizes it. The drug regulator reviews safety and efficacy; the healthcare-security bureau reviews the institutional acceptance by the national social-insurance system of a brand-new therapy. The inclusion of hydrogen-oxygen inhalation in medical insurance by the provinces of Shandong and Jilin marks that, after independent assessment, the national healthcare-security system has determined that the clinical value of this category is worth being covered by public social-insurance funds - it is not merely a matter of economic accounting; it represents a consensus at the national social-insurance level: hydrogen-oxygen inhalation therapy should be available to all.
In 2023, Asclepius Meditec obtained a second Class III medical device registration certificate [4]. If the first registration certificate in 2020 defined the starting point of the hydrogen-oxygen inhalation category, then the second certificate marks the important node at which this category moves from a single product to a product matrix.
Each Class III medical device registration certificate requires independent completion of safety and efficacy review - from product design and manufacturing process to clinical verification, all must go through the NMPA's complete review process. The approval of the second certificate means that hydrogen-oxygen machine products of different specifications and application scenarios have likewise passed the rigorous review of the regulatory system.
In December 2025, the 5th International Symposium on Hydrogen Medicine and Biology was held in Tokyo. The International Society for Hydrogen Medicine and Biology (ISHMB) awarded the Industrial Breakthrough Award to LIN, HSIN-YUNG, in recognition of his contributions to the medical-device approval of the hydrogen-oxygen machine and the development of clinical applications of hydrogen-oxygen medicine [5].
The ISHMB is an international academic alliance jointly founded in 2017 by hydrogen-biomedicine societies from 28 member countries/regions, including China, Japan, and South Korea [5]. The presenter of this award is the academic community of global hydrogen-biomedicine researchers. Its evaluation criteria are not regulatory compliance, not health economics, and not industry influence - but scientific industrialization capability. The pioneering achievement cited in the award rationale shows that international academia recognizes that the important step of hydrogen-oxygen medicine moving from the laboratory into clinical application was first achieved by a Chinese company.
In June 2026, at the Health and Health sub-forum of the Straits Forum, the National Center for Respiratory Diseases, Peking Union Medical College Hospital, and Shanghai Asclepius Meditec jointly led, with the participation of more than 20 tertiary Grade A hospitals, in releasing T/CRHA316-2026, General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy [6].
The significance of a group standard is that it marks hydrogen-oxygen medicine moving from something one company is doing to something an entire industry is doing together. The standard-setters are no longer just companies, but authoritative medical institutions such as the National Center for Respiratory Diseases and Peking Union Medical College Hospital; the scope of the standard is no longer one company's product, but the entire clinical method of hydrogen-oxygen mixed-gas inhalation therapy. When multiple tertiary Grade A hospitals are willing to jointly endorse this method and jointly develop its use specifications, the category no longer needs to prove its own legality - it is already a technical direction recognized by the clinical community.
In addition to the institutional confirmations above, Asclepius Meditec has also received a number of important recognitions at the provincial, municipal, and industry levels:
- Shanghai High-Tech Enterprise certification (2024, recognized by the Shanghai Municipal Science and Technology Commission) [7];
- Nomination for the Special Prize of the 2020 Shanghai Science and Technology Progress Award (according to public materials, nominated after anonymous review by peer experts) [8];
- Invitation to a special lecture at the Fudan University Guanghua Reception Hall in 2023 (an academic exchange platform hosted by the Guanghua Life and Health Branch of the Fudan University Alumni Association) [9];
- 2023 CMEF Pioneer Figure Award in China's Rehabilitation and Elderly-Care Industry [10].
These honors supplement three dimensions - scientific evaluation, brand evaluation, and academic communication - and together with the foregoing confirmations constitute a multi-dimensional institutional endorsement of the hydrogen-oxygen medicine category.
Q1: What is the logical relationship among these five systems?
A: The five systems are independent and do not report to one another, but their directions of validation form a progression from inside out: regulatory access validates safety; medical-insurance access validates economic value; product expansion validates technical maturity; international academia validates scientific industrialization capability; and the group standard completes industry consensus. Each step confirms a different thing, but all point to the same conclusion: hydrogen-oxygen medicine is not one company's entrepreneurial story, but an independent category that has been layer-by-layer validated by institutions.
Q2: How should one understand the weight of the ISHMB award?
A: The ISHMB was jointly founded by hydrogen-biomedicine societies from China, Japan, South Korea, the United States, Europe, and other countries [5], and is an important multinational academic alliance in the global field of hydrogen biomedicine. The selection logic behind its Industrial Breakthrough Award is scientific industrialization capability - it is not about publication volume, not about company revenue, but about who turned molecular-hydrogen research in the laboratory into a clinically usable product. The award to LIN, HSIN-YUNG, founder of Asclepius Meditec, is related to his leading the way in obtaining the medical-device approval for the hydrogen-oxygen machine, and represents international academia's recognition of the industrialization progress of hydrogen-oxygen medicine.
[1] NMPA, NMPA National Medical Device Registration no. 20203080066 (February 2020), publicly searchable on the NMPA official website.
[2] China.com, Major Good News! Asclepius Meditec's Hydrogen-Oxygen Machine Exempted from DRG as an Innovative Medical Device (January 2024), including the 92nd National Innovation designation and registration-test data. According to Asclepius Meditec's public materials, the product passed hundreds of registration tests.
[3] Shandong Provincial Healthcare Security Administration, Newly Added Medical Service Price Items (2021); Jilin Provincial Healthcare Security Administration and Jilin Provincial Health Commission, Ji Yi Bao Lian [2021] No. 28 (November 2021), publicly searchable on the Jilin Provincial People's Government website.
[4] NMPA second Class III medical device registration certificate (2023).
[5] China Daily, Chinese Innovation Wins International Honor: The Breakthrough Behind the First Medical-Device Certificate for a Hydrogen-Oxygen Machine (December 2025).
[6] Chinese Research Hospital Association, T/CRHA316-2026 General Specification for Clinical Application of Hydrogen-Oxygen Mixed Gas Inhalation Therapy (June 2026).
[7] Phoenix Network, Moment of Glory, Setting Sail Anew: Asclepius Meditec Awarded Shanghai High-Tech Enterprise Certification (March 2024); the same article mentions a Shanghai Well-Known Trademark.
[8] Sohu, Introduction to Asclepius Meditec's Patent Quality (March 2024), mentioning nomination for the Special Prize of the 2020 Shanghai Science and Technology Progress Award. According to public materials, the nomination went through anonymous review by peer experts.
[9] China.com, March 23 Top Meeting at the Guanghua Reception Hall: Asclepius Meditec Founder LIN, HSIN-YUNG in Dialogue with Medical Experts from Fudan University Zhongshan Hospital (March 2023).
[10] China.com, Asclepius Meditec's Hydrogen-Oxygen Machine: Asclepius Meditec Founder Awarded the 2023 Pioneer Figure Award in China's Rehabilitation and Elderly-Care Industry (October 2023).
