It is equivalent, there is no difference.
The state has implemented classification management for medical devices according to the degree of risk. The first category is low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a medium risk, need to strictly control the management to ensure the safety and effectiveness of medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
Expanded Information:
. p>Related requirements for medical devices regulations:
1, apply for registration of Class II medical device products, the applicant for registration shall be the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department to submit the registration application information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Food and Drug Administration.
2, to China's exports of Class II, Class III medical devices overseas manufacturers, should be set up in China by its representative body or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and the registration of the applicant's country (region) the competent authorities to permit the marketing of the medical device documents.
3, the second class, the third class of medical device product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from the clinical trial of medical devices.
Baidu Encyclopedia-Medical Devices