(1) For products in which drugs play a major role and medical devices play an auxiliary role (such as syringes pre loaded with drugs), they shall be managed according to drug regulations.

(2) For products in which medical devices play the main role and drugs play an auxiliary role (such as drug-containing stents, catheters with antibacterial coatings, drug-containing condoms, drug-containing intrauterine devices, etc.), they shall be managed according to medical device regulations.

(3) Wound patches containing antibacterial and anti-inflammatory drugs are managed according to drug regulations.

(4) Traditional Chinese medicine topical application products, as traditional Chinese medicine topical applications, are managed according to drug regulations,

The "Regulations on the Supervision and Administration of Medical Devices" promulgated by the State Council on January 4, 2000 defines medical devices as instruments, equipment, appliances, materials, or other items used alone or in combination with the human body, including required software; Its effects on the surface and body of the human body are not obtained through pharmacological, immunological, or metabolic methods, but these methods may be involved and play a certain auxiliary role; Its use aims to achieve the following expected purposes:

（1） Prevention, diagnosis, treatment, monitoring, and mitigation of diseases;

（2） Diagnosis, treatment, monitoring, relief, and compensation for injury or disability,

（3） Research, substitution, and regulation of anatomical or physiological processes;

（4） Pregnancy control.