Condoms are classified as Class II hospital devices.
According to the "Supervision and Administration of Medical Devices", condoms are classified as Class II medical devices and need to be filed with the Class II medical device qualification.
It is recommended that you check the packaging of the condom products on the "Food and Drug Administration (quasi) word" labeling, labeled "Food and Drug Administration (quasi) word XXXX XXXX No. 2XXXXXXX" that is, the second class of medical devices. At the same time, the condom belongs to the adult products, so you also need to apply for adult products qualification record.
The second class of medical devices business record for the first time to record the conditions for acceptance:
1. With the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a state-recognized relevant professional qualifications or titles.
2. With the business scope and scale of operation of the business, storage space.
3. With the business scope and scale of operation of the storage conditions, all entrusted to other medical equipment business enterprises can not set up storage.
4. With the operation of medical devices and quality management system appropriate.
5. With the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support.