Since June 1, 2014, engaged in the second class of medical equipment business, business enterprises should fill out the second class of medical equipment business filing form to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the filing materials of the second class of medical equipment business.
Receiving medical device business filing materials, the municipal food and drug supervision and management departments should be field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers.
The second class of medical equipment business filing vouchers for the record number numbering rules for: XX food and drug supervision and mechanical business XXXXXXXXXX. Where: the first X on behalf of the record department of the province, autonomous region, municipality directly under the central Chinese abbreviation, the second X on behalf of the location of the municipal administrative region of the Chinese abbreviation, the third to six X on behalf of the 4-digit year of filing, the seventh to ten X on behalf of the 4-digit number of filing water number.
Expanded Information:
There is a difference between leniency and strictness: high-risk products are "pressurized" and low-risk products are "loosened".
China's medical devices are many types, spanning a wide range of small to tongue depressors, masks, large to the nuclear magnetic **** vibration instruments and other types of diagnostic and therapeutic equipment, the risk of various products vary greatly, both directly affecting the implantable life safety of the device, but also on the health of the body does not have a direct impact on the auxiliary equipment.
"These characteristics of medical devices determine both the implementation of strict management, but not 'one size fits all'." Wang Zhenjiang, director of the UNESCO and Health Department of the State Council Legislative Affairs Office, said that the current classification and management system of medical device regulatory regulations is not perfect.
Some measures do not reflect the differences in classification, the supervision of high-risk products is not enough, and the supervision of some low-risk products that should be liberalized has not been liberalized, and the burden on enterprises is heavy.
Wang Zhenjiang said, in response to this problem, the newly revised regulations clearly stipulate that the medical devices according to the degree of risk to implement classification management, according to the risk from low to high medical devices are divided into one, two, three categories.
And according to the medical device production and operation of the use of product classification directory timely dynamic adjustment, and requires the development of adjustments to the directory, to fully listen to the views of all parties, with reference to the international practice of medical device classification. At the same time improve the classification of regulatory measures, follow the principle of leniency and strict differentiation, focusing on the supervision of high-risk products.
In terms of product management, it is clear that the first class of medical devices to implement product filing management, the second class by the provincial food and drug regulatory departments to implement product registration management, and the third class by the State Administration of the implementation of product registration management.
The whole process of governance: to strengthen the "during" "after" supervision
Hu Yinglian, associate professor at the National School of Administration, believes that the regulations further simplify and decentralize the approval of the production and operation of medical devices. But before the license is reduced, and after the incident supervision and follow up is particularly important.
Baidu Encyclopedia - Class II medical device business filing