Secondly, to operate some Class II devices, it is also not required.
The directory is as follows:
Notice on the publication of the first batch of Class II medical device products that do not need to apply for a Medical Device Operator's License
/WS01/CL0845/10400.html
Other Class II and III medical devices, all of them need to apply for a medical device operator's license now.
How about confirming which class of medical devices you are dealing with:
Look at the medical device registration number:
The registration number is organized as follows:
×(×)1 (food) drug supervision and mechanical (×2) word ××××3 No. ×4××5 ××××6. Where:
×1 for the registration and approval of the department of the location of the abbreviation:
The third class of medical devices within the territory of medical devices, medical devices outside the territory, as well as Taiwan, Hong Kong, Macao and medical devices for the word "country";
International second class of medical devices for the registration and approval of the department of the province, autonomous region, Municipalities directly under the Central Abbreviations;
The first class of medical devices in the territory of the registration and approval department of the province, autonomous region, municipality directly under the Central Abbreviations plus the abbreviation of the municipal administrative region, as × × 1 (without the corresponding municipal administrative region, only for the province, autonomous region, municipality directly under the Central Abbreviations);
×2 for the form of registration (quasi, into the permit, permit):
The word "permit" applies to medical devices within the territory;
"In" applies to medical devices outside the territory;
"Permit" applies to medical devices in Taiwan, Hong Kong and Macao;
"Permit" applies to medical devices in Taiwan, Hong Kong, Macau;
××××3 is the year of approval for registration;
×4 is the product management category;
××5 is the product variety code;
××××6 is the registration number.