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Answer
  (1) For products where drugs play the main role and medical devices play the role of auxiliary drugs (such as syringes with preloaded drugs, etc.), they are managed as drugs.
  (2) For products that are mainly used by medical devices and supplemented by drugs (such as medicated stents, catheters with antibacterial coatings, medicated condoms, medicated birth control rings, etc.), they are managed as medical devices.
  (3) Wound dressings containing antibacterial and anti-inflammatory drugs are managed according to drugs.
Categories:
Medical common sense
2019-08-08 17:08:00
Categories:
Medical common sense
2019-08-08 17:07:17
Answer
  Medical device products are divided into 3 categories.
  The first category of medical devices refers to medical devices that can ensure their safety and effectiveness through routine management.
  The second category of medical devices refers to medical devices whose safety and effectiveness should be controlled.
  The third category of medical devices refers to medical devices that are implanted in the human body; used to support and maintain life; they are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled.
 
Categories:
Medical common sense
2019-08-08 17:07:17
Categories:
Medical common sense
2019-08-08 17:06:22
Answer
  The "Regulations on the Supervision and Administration of Medical Devices" promulgated by the State Council on January 4, 2000 defines a medical device, that is, a medical device refers to an instrument, equipment, appliance, material, or other items used on the human body alone or in combination, including the necessary The software; its use on the body surface and in the body is not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; its use is intended to achieve the following expected purposes:
  (1) Prevention, diagnosis, treatment, monitoring, and alleviation of diseases;
  (2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;
  (3) Research, substitution, and adjustment of anatomical or physiological processes;
 
Categories:
Medical common sense
2019-08-08 17:06:22
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