Medical device class I and II difference is: medical devices in accordance with the degree of risk is different.
1, the first class is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
2, the second class is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
3, the third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Expanded Information:
1, the first class of medical device products for the record, by the filing of the municipal people's government to the location of food and drug supervision and management department to submit the record. Information.
2, the export of Class I medical devices to China's territory of foreign production enterprises, set up by its representative office in our country or designate the enterprise legal person in our country as an agent, to the State Council Food and Drug Administration to submit the filing information and the filer's country (region) competent authorities to authorize the sale of the medical device on the market documents.
3, apply for registration of Class II medical device products, the applicant for registration shall be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to submit the registration application information.
4, apply for registration of Class III medical device products, the applicant shall submit an application for registration to the Food and Drug Administration of the State Council.
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