Where is the qualification of Class II medical devices?
One class is to the city to be furnished for the record;
The second class of medical devices is to the provincial, municipal, autonomous region of the provincial food and drug administration.
The third class of medical devices is to the State Food and Drug Administration to apply for a medical device registration certificate
What is the qualification of the second class of medical devices?
The opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions and municipalities directly under the Central People's Government Drug Administration for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions and municipalities directly under the Central People's Government Drug Administration for examination and approval, and issued the "medical equipment business enterprise license".
How to prepare for the filing of Class I, Class II and Class III medical devices?
June 1, 2014 has been obtained before the second class of medical devices business license, do not need to re-apply for the record. The expiration of the business license to continue to engage in business, should apply for the record.
June 1, 2014 has been accepted before the second class of medical devices business license application, the acceptance of the food and drug supervision and management department to notify the enterprise in accordance with the new provisions for the record.
Taobao Class II medical devices can be handled off-site?
Yes, you can.
At present, the national application for Class 2 medical device business filing can be sold on Taobao
Is Class 2 filing a business license?
No.
The Class 2 medical device business record certificate is the operation of Class 2 products are required to apply for, the medical device license is the operation of Class 3 products need to apply for. The difference between the two is as follows:
One, the second class of business filing certificate needs to be filed, the medical device business enterprise license is the approval system;
Two, the second class of medical equipment business filing certificate office address sampling, the office address of the medical device business enterprise license shall be verified, the requirements of the medical device management system is complete, complete personnel, office, warehouse equipment, cold storage in line with the acceptance criteria. Acceptance standards.