NMPA: Medical Device Products Utilizing Nanomaterials

I. Purpose

To guide the determination of the regulatory attribute and management category of medical device products utilizing nanomaterials (hereinafter referred to as nano-devices), 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," the "Notice on Matters Concerning the Registration of Drug-Device Combination Products," and other relevant regulations.

II. Scope

1 The nano-devices referred to in these guiding principles are products that contain nanomaterials, where the part/component containing the nanomaterials directly or indirectly contacts the human body, and which conform to the definition of a medical device in the "Regulations for the Supervision and Administration of Medical Devices."

Note 1: Nanomaterial refers to any material with external dimensions, internal structure, or surface structure at the nanoscale, see GB/T 39855---2021 "Definition, Classification and Naming of Nano-Products."

Note 2: Nanoscale refers to the size range from 1 nm to 100 nm, see GB/T 39855---2021 "Definition, Classification and Naming of Nano-Products."

Note 3: If a medical device product contains nanomaterials, but the part/component containing the nanomaterials does not directly or indirectly contact the patient, its classification does not apply to these guiding principles. For example, tires of medical transport vehicles prepared with added nanocellulose material do not directly or indirectly contact the patient; therefore, the classification of the medical transport vehicle does not apply to these guiding principles.

Note 4: If the medical device product itself does not contain nanomaterials but may form nano-substances due to degradation or wear, although the risk assessment of such products should focus on this issue, this situation does not apply to these guiding principles.

2 These guiding principles do not apply to in vitro diagnostic reagent products utilizing nanomaterials.

III. Definition of Regulatory Attribute

The regulatory attribute of a product utilizing nanomaterials shall be comprehensively determined based on the product's intended use, mechanism of action, etc.

1  If the product does not conform to the definition of a medical device in the "Regulations for the Supervision and Administration of Medical Devices," it is not managed as a medical device. For example:

1） The product is nano-microspheres:

       (1) If they are only used for drug loading, are not pre-loaded with drugs upon leaving the factory, and require doctors to load the drugs at clinical institutions before use or are sold to medical institutions after being loaded with drugs by other enterprises, they are not managed as medical devices.

       (2) If they are only used for drug loading and are pre-loaded with drugs upon leaving the factory for direct clinical use, they are not managed as medical devices.

2）If the product achieves its intended use solely through the antibacterial therapeutic effect of the nanomaterials, it is not managed as a medical device.

2 If the product achieves a medical device purpose and also contains components that exert pharmacological, immunological, or metabolic effects, it shall be managed as a drug-device combination product. Usually, it is determined as a drug-device combination product primarily acting as a drug or primarily acting as a medical device based on the product's primary mode of action. Among these:

1） Medical dressings containing nano-antibacterial materials (except nano-silver):

    Medical dressing products claiming antibacterial therapeutic effects through nano-antibacterial materials (except nano-silver) shall provide non-clinical pharmacodynamic studies and/or clinical studies to confirm whether the product has an antibacterial therapeutic effect. Non-clinical pharmacodynamic studies and/or clinical studies and evaluation criteria used to determine whether the product has an antibacterial therapeutic effect can refer to non-clinical and clinical technical guidelines related to drug development.

       (1) If non-clinical pharmacodynamic studies and/or clinical studies confirm that the product has a clear antibacterial therapeutic effect, products that primarily achieve their intended use through the antibacterial therapeutic effect are determined to be drug-device combination products primarily acting as drugs; products that primarily achieve their intended use through physical wound coverage, exudate absorption, etc., are determined to be drug-device combination products primarily acting as medical devices.

       (2) If non-clinical pharmacodynamic studies and/or clinical studies do not show that the product has an antibacterial therapeutic effect, it is managed as a medical device.

2）If the product is nano-microspheres, which have both a medical device purpose (e.g., as vascular embolization microspheres) and are pre-loaded with drugs upon leaving the factory, it shall be managed as a drug-device combination product. Usually, it is determined as a drug-device combination product primarily acting as a drug or primarily acting as a medical device based on the product's primary mode of action.

3  If the product conforms to the definition of a medical device in the "Regulations for the Supervision and Administration of Medical Devices" and does not contain components that exert pharmacological, immunological, or metabolic effects, it is managed as a medical device.

IV. Definition of Medical Device Management Category

Unless otherwise specified, the management category of a nano-device shall be comprehensively determined based on factors such as the possible contact site, exposure pathway, and exposure time of the nanomaterials, as well as the product's intended use, material characteristics, structural features, and form of use. Its classification code shall be determined according to the product's intended use, with reference to the "Medical Device Classification Catalog."

1  The management category of a nano-device shall not be lower than Class II.

2  Nano-devices that only contact intact skin surfaces of the human body are managed as Class II medical devices; nano-devices that contact other parts of the human body (e.g., internal tissues, mucosal cavities, etc.) or wounds, besides intact skin surfaces, are managed as Class III medical devices.

3  Determination of the management category for specific types of nano-devices, for example:

1）  If the product is a mild thermal therapy device/appliance for use on intact skin surfaces, applied directly to the affected area during use, transferring heat to the affected area by conduction to promote local blood circulation and relieve pain, such as a medical thermal patch containing nano far-infrared ceramic powder, it is managed as a Class II medical device.

2） If the product is a medical dressing for wound care, it is managed as a Class III medical device.

3） If the product is a root canal sealing material among dental filling and restorative materials, a dental implant among oral implant and tissue reconstruction materials, or an auxiliary material for the treatment of oral ulcers or oral tissue wound healing, it is managed as a Class III medical device; if the product is a pit and fissure sealant among anti-caries materials, or an orthodontic adhesive among dental filling and restorative material adhesives, and the contained nanomaterials are not released or shed in nanoform after curing, it is managed as a Class II medical device.

4） If the product is an orthopedic filling and repair material for bone filler implantation, defect repair, etc., such as medical nano-hydroxyapatite bone filler material, it is managed as a Class III medical device.

5） If the product is nano-microspheres functioning as vascular embolization microspheres, used to control vascular bleeding caused by aneurysms, certain tumor arteriovenous malformations, or for arterial and venous embolization of the vascular system, it is managed as a Class III medical device.

V. Special Provisions

Special provisions are made for products containing nano-silver成分 (nano-silver components) as follows:

1  If the product contains nano-silver components and does not contain other components that exert pharmacological, immunological, or metabolic effects:

1）  If the product primarily achieves its intended use through the antibacterial therapeutic effect of the nano-silver components, such as solutions or gels containing nano-silver, it is not managed as a medical device.

2）  If the nano-silver components in the product are only compounded onto the medical device to add an antibacterial function, and the antibacterial function is auxiliary, such as a catheter with a nano-silver coating, medical dressings containing nano-silver components (excluding liquid, paste, and gel dressings), etc., they are managed as Class III medical devices.

2  If the product has a medical device purpose and, in addition to nano-silver components, contains other components that exert pharmacological, immunological, or metabolic effects, it is managed as a drug-device combination product. Usually, it is determined as a drug-device combination product primarily acting as a drug or primarily acting as a medical device based on the product's primary mode of action.