NMPA: Rehabilitation Digital Therapy Software Products

I. Purpose

To guide the determination of the regulatory attribute and management category of rehabilitation digital therapy software products, these guiding principles are formulated according to the "Regulations for the Supervision and Administration of Medical Devices," the "Medical Device Classification Rules," the "Medical Device Classification Catalog," and other relevant regulations.

II. Scope

These guiding principles apply to digital therapy software products that utilize digital technologies to achieve purposes such as alleviating patients' functional impairments or compensating for or reconstructing lost functions. The core function of such products is rehabilitation training, while prevention, assessment, screening, and diagnosis may serve as auxiliary functions. Such products may be included under "21-06-01 Rehabilitation Training Software" in the "Medical Device Classification Catalog."

These guiding principles do not apply to digital therapy software products in non-rehabilitation training fields such as chronic disease management, pain relief, or treatment of mental or psychological disorders.

Note: According to ISO/TR 11147:2023 "Health informatics — Personalized digital health — Digital therapeutic health software systems," a digital therapeutic health software system refers to health software designed to treat or alleviate diseases, disorders, conditions, or injuries by generating and delivering medical interventions that have a significant positive therapeutic impact on patient health. This definition may currently be referenced to determine whether a product belongs to a digital therapy software product.

III. Principles for Defining Regulatory Attributes

1 Characteristics that rehabilitation digital therapy software products must simultaneously possess:

1. Provide software program-driven interventions to patients to offer rehabilitation training for functional impairments caused by diseases, injuries, or physiological structural defects.

2) Have clear clinical intended uses, usage scenarios, usage limitations, indications, and contraindications.

3) Be based on evidence-based medicine and follow recognized rehabilitation medical theories, such as clinical guidelines, standard treatment protocols, expert consensus, clinical studies, etc.

2  Situations not considered rehabilitation digital therapy software products:

1. Those used solely for personal health management (management of health behaviors and lifestyles, or electronic/scale-based statistics of publicly available documents, etc.) and not for rehabilitation training.

2. Those serving only as a communication platform between healthcare providers and patients during rehabilitation training, without providing interventions such as rehabilitation training plans for patients.

3. Those functioning merely as platforms for playing publicly available audio or video content in the rehabilitation field, without being based on evidence-based medicine.

Products with only the aforementioned intended uses do not meet the definition of a medical device and are not considered medical devices.

IV. Principles for Determining Management Category

For rehabilitation digital therapy software managed as medical devices, the management category needs to be comprehensively determined based on factors such as its intended use and algorithm maturity.

1  If the product is intended for rehabilitation training of speech, visual, and auditory impairments, or for motor rehabilitation, it is managed as a Class II medical device.

2  If the product is intended for rehabilitation training of mild cognitive impairment caused by organic lesions such as stroke, and does not involve rehabilitation training for mental or psychological disorders, it is managed as a Class II medical device.

3  If the product utilizes artificial intelligence technology to achieve its intended purpose, it shall be implemented with reference to the "Guiding Principles for the Classification and Definition of Artificial Intelligence Medical Software Products."

4  If the product is intended to be used in conjunction with or cooperate with auxiliary devices to achieve rehabilitation training, it needs to be comprehensively determined in combination with the management category of the auxiliary device.