This is not explicitly stipulated and can be sold directly.
According to the "supervision and management of medical devices regulations" Chapter IV, Article 30: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the regulations of the proof of information.
Engaged in medical device business activities, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Expanded Information:
The first class of medical device filing
A class of medical devices for the record
1, medical devices for the record refers to the food and drug supervision and management department of the medical device filing (hereinafter referred to as the filer) to submit the first class of medical devices for the record information on file for inspection.
2, the implementation of the record of medical devices for the first class of medical devices catalog and the corresponding in vitro diagnostic reagents classified subdirectory of class I medical devices.
Inside the first class of medical devices for the record, the filing of municipal food and drug supervision and management departments to submit the record information. Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Hong Kong, Macao, Taiwan medical equipment for the record, with reference to the import of medical devices.
3, for the record of imported medical devices, should be registered in the filer or production address in the country (region) to obtain marketing authorization for medical devices.
Baidu Encyclopedia - Class I Medical Devices
Baidu Encyclopedia - Class II Medical Devices