How to distinguish between drugs and medical devices containing drug ingredients?
Release time:
2024-08-30
For products where drugs play the main role and medical
(1) For products where drugs play the main role and medical devices serve as auxiliary drugs (such as syringes pre loaded with drugs), they shall be managed according to drug regulations.
(2) For products where 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 dressings containing antibacterial and anti-inflammatory drugs are managed according to drug regulations.
(4) Traditional Chinese medicine external application patches, as traditional Chinese medicine external application patches, are managed according to drug regulations.
Related News
Are all equipment suitable for home use?
2024-08-30
What are the causes of adverse events in medical devices?
2024-08-30
Enterprises engaged in disposable medical, hygiene product materials, and medical and health protective equipment