中山市TBT預(yù)警防控平臺
——技術(shù)性貿(mào)易措施資源
The definition and classification
時間: 2020-10-21
“Regulations for the Supervision and Administration of Medical Devices” as the legal basis for medical devices regulation took effective on April 1st, 2000, the Article 3 of which gave a definition for “medical device”.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:
l Diagnosis, prevention, monitoring, treatment or alleviation of a disease;
l Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
l Investigation, replacement or modification for anatomy or a physiological process;
l Control of conception.
SFDA administer medical devices are based on classification. In China, medical devices are generally classified into three different groups as shown in Table 1.
Table 1. Classification of medical devices in China
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CATEGORY
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scope and dEFINITION
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Class Ⅰ devices
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Safety and effectiveness can be ensured through routine administration
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Class Ⅱ devices
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Further control is required to ensure safety and effectiveness
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Class Ⅲ devices
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Implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.
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Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority. For medical devices that do not belong to these three categories, companies have to submit an application to SFDA for classification.
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn