Guiding Principles for the Definition of New Biomedical Technologies, Drugs and Medical Devices (Interim)

New biomedical technologies represent an important new quality productive force driving the progress of modern medicine and the development of public health undertakings, and play a vital role in enhancing people’s health and well-being. To standardize the clinical research and clinical transformation and application of new biomedical technologies, promote advances and innovation in biomedical science and technology, safeguard medical quality and safety, and clarify the administrative boundaries between competent authorities, the National Health Commission, together with the National Medical Products Administration, formulates these Guiding Principles in accordance with Article 55 of the Regulations on the Administration of Clinical Research and Clinical Transformation & Application of New Biomedical Technologies (hereinafter referred to as the Regulations) and in light of the actual development of new biomedical technologies, drugs and medical devices.

I. General Approach

The definition of new biomedical technologies, drugs and medical devices shall be carried out following the approach below.

1. Coordinating development and safety

Emerging new biomedical technologies create more opportunities for industrial development and public health improvement, while also posing challenges to maintaining the bottom line of industry safety. The definition shall balance development and safety, focusing mainly on new biomedical technologies that are difficult to be developed into medical devices, as well as those with high innovation and personalization that cannot yet or are difficult to be developed into drugs. It standardizes their clinical research and translational application, supporting development on the premise of ensuring safety.

2. Being oriented to meeting people’s health needs

For certain diseases, traditional drug R&D features high costs and long cycles; for rare diseases, small market scale and insufficient R&D motivation remain prominent problems. The development of new biomedical technologies provides more treatment options for such patients. The definition shall be people’s health demand-oriented, focusing on offering new therapeutic directions for diseases with no effective treatment available, accelerating the progression of such technologies from conceptual exploration to clinical verification, enriching clinical treatment options and accumulating preliminary experience for industrial R&D.

3. Fully considering characteristics of different development stages

New biomedical technologies show distinct characteristics in early stages such as preclinical and clinical research, as well as in later translational application stages, with rapid iteration and high uncertainty regarding future clinical transformation. The definition shall fully respect stage-specific features, adopt differentiated definition methods for technologies at different stages, adapt to their high innovation, strong personalization and diverse translational forms, and guide standardized clinical research and application.

4. Emphasizing policy coherence and inter-departmental coordination

China has established a mature administration system for drugs and medical devices. The Regulations create a new pathway for clinical research and translational application of new biomedical technologies, fostering a more diversified and dynamic innovation ecosystem. The definition shall stress policy alignment and inter-departmental coordination, realize dislocation development and functional complementarity with the drug and device regulatory system, promote in-depth integration of industry, academia, research and clinical practice, and jointly drive technological progress and industrial development.

II. Definition of New Biomedical Technologies at the Clinical Research Stage

At early stages including preclinical and clinical research, new biomedical technologies feature rapid iteration, multiple influencing factors and high uncertainty in future transformation. In a spirit of inclusiveness and prudence, to support innovation, standardize technical naming and filing requirements, and improve filing efficiency and quality, the national health authority shall formulate and adjust the Guiding List for the Filing of Clinical Research on New Biomedical Technologies (hereinafter referred to as the Filing Guiding List), to guide clinical research initiators to independently classify the attribute of technologies to be launched for clinical research.

Clinical research initiators shall independently judge the attribute of technologies with reference to the Filing Guiding List. Those classified as biomedical technologies shall complete document submission and file records in accordance with standardized names and filing requirements specified in the List. Those classified as drugs or medical devices shall conduct relevant work in compliance with drug and device regulations.

For technologies involving boundary definition between new biomedical technologies and drugs: if classified as a new biomedical technology and filed for clinical research, the generated clinical data shall support its subsequent clinical transformation and application. If developed as a drug, clinical trials may only be launched upon official approval, followed by marketing registration application. The National Health Commission entrusts professional institutions to provide consultation on attribute definition for clinical research initiators.

1. Formulation of the Filing Guiding List

The National Health Commission organizes experts to formulate the List. Technologies included shall comply with the following principles:

1. Legality and compliance: Conform to laws, administrative regulations and national provisions, abide by ethical principles, and shall not harm public interests or national security.

2. Clear medical purpose: Aim at health status assessment, disease prevention, treatment and health promotion; contribute to the prevention and treatment of major chronic diseases, infectious diseases, pediatric diseases, rare diseases and other conditions, and meet clinical and public health needs.

3. Clear mechanism and principle: The biological mechanism to achieve medical purposes shall be complete and well-supported by sufficient evidence; the direct acting biological structure or functional link operates at the molecular or cellular level.

4. Sufficient preliminary foundation: Necessary non-clinical studies such as laboratory research and animal experiments have been legally completed; sufficient evidence supports safety and efficacy to enable clinical research. For technologies acting on germ cells, embryos and fetuses, sufficient demonstration on offspring safety is required.

5. Not yet clinically applied: Innovative and advanced, being professional medical means and measures not yet applied clinically within China.

2. Adjustment of the Filing Guiding List

The National Health Commission dynamically adjusts the List according to technological development and clinical demands, solicits opinions from relevant authorities and stakeholders in accordance with the law, and publishes the List publicly. A dynamic adjustment mechanism is established for institutional inclusion proposals.

(1) Addition to the List

Institutions may propose to include eligible technologies not yet listed, and submit standardized technical name, medical purpose, mechanism principle, qualified non-clinical research reports, and necessity demonstration reports for clinical research. Specific requirements and procedures shall be formulated separately.

The National Health Commission organizes experts in medicine, life sciences, pharmacy, medical devices and ethics to conduct demonstration. Eligible technologies shall be incorporated into the List, with dedicated filing guidelines formulated to standardize clinical research conduct.

(2) Removal from the List

① Direct removal

A technology already included shall be directly removed under any of the following circumstances:

• Explicitly prohibited by laws, administrative regulations or national provisions;

• Having major ethical concerns;

• Having critical safety or efficacy defects;

• Causing uncontrollable risks or major adverse social impacts during clinical research.

Removed technologies shall no longer carry out clinical research or translational application under the Regulations. Ongoing filed projects shall be terminated promptly, with the rights and interests of research subjects properly protected.

② Removal after expert demonstration

If drugs or medical devices with basically identical indications and mechanisms have been approved for marketing in China, or if equivalent technologies have been approved as regulated medical technologies, the National Health Commission shall consult the National Medical Products Administration to organize timely demonstration and adjust the List accordingly.

After removal, new relevant clinical research shall follow the Measures for the Administration of Investigator-Initiated Clinical Research in Medical and Health Institutions (Guo Wei Ke Jiao Fa〔2024〕No.32). Ongoing filed research before removal may continue until completion upon re-ethical review, or be terminated as appropriate.

Technologies retained after demonstration shall avoid repetitive research by comparing with approved drugs, devices and clinical application technologies in terms of indications and mechanisms.

III. Definition of New Biomedical Technologies at the Clinical Transformation and Application Stage

Highly personalized technologies with no marketed drugs or initiated pivotal clinical trials adopting the same mechanism principle may apply to the National Health Commission for clinical transformation and application as new biomedical technologies. Technologies for rare disease treatment with no marketed drugs or pivotal trials for identical indications and mechanisms are also eligible for such application.

Technologies conforming to the definition of medical devices under the Regulations on the Supervision and Administration of Medical Devices shall complete regulatory registration in accordance with device laws and regulations, and are not eligible for application as new biomedical technologies.

The National Health Commission entrusts professional institutions to assess applications. Technologies proven safe, effective and ethically sound by clinical research, with consistent safety and efficacy conclusions achievable by other qualified institutions and professionals following operational specifications, shall be reviewed and approved and incorporated into regulated medical technology administration.

Upon approval, eligible medical institutions and professionals may carry out clinical application in accordance with relevant provisions and assume primary responsibilities. Specific application requirements, procedures and review rules shall be formulated separately by the National Health Commission.

IV. Miscellaneous Provisions

1. These Guiding Principles shall be interpreted jointly by the National Health Commission and the National Medical Products Administration.

2. These Guiding Principles shall come into force on May 1, 2026.

Appendix

Guiding List for the Filing of Clinical Research on New Biomedical Technologies (Version 1)

Scan the QR code to view the appendix.

Source: Official Website of the National Health Commission