How do you distinguish between a drug and a medical device that contains a drug ingredient?


Release time:

2024-08-30

For products that are mainly drugs and supplemented by medical devices

How do you distinguish between a drug and a medical device that contains a drug ingredient?

(1) For products that are mainly drugs and supplemented by medical devices (such as syringes with pre-filled drugs), they should be managed in accordance with drug regulations.
(2) For products that are mainly medical devices and supplemented by drugs (such as drug-containing stents, catheters with antibacterial coatings, drug-containing condoms, drug-containing intrauterine devices, etc.), they should be managed in accordance with medical device regulations.
(3) Wound dressings containing antibacterial and anti-inflammatory drugs are administered in accordance with drug regulations.
(4) Traditional Chinese medicine external use patch as a traditional Chinese medicine external use patch, in accordance with drug regulations for management.

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