Device record number refers to the approved batch number of products such as medical devices or health care plasters. Belonging to medical instrument products. It is not a medicine, but a medical instrument. It is a low-risk medical device, and the implementation of national routine management can ensure its safety and effectiveness.
The name of machinery has clinical curative effect, which can be directly written in the manual and tested by clinical observation. Mechanical brand products are safer and have been put on record by the US Food and Drug Administration.
Do I need to go to the Food and Drug Administration for filing a class I medical device?
No need. According to the new "Measures for the Supervision and Administration of Medical Device Operation", the operation of Class I medical devices does not require permission and filing; The management of Class II medical devices shall be put on record; The operation of the third category of medical devices is subject to license management, and it is not necessary to file the first category of medical devices only, but to file the first category of medical devices.
Legal basis: Measures for the Supervision and Administration of Medical Device Operation
Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of the operation of medical devices nationwide. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.
Article 4 Medical devices shall be classified and managed according to their risk degree.
There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.
How to inquire about the medical device registration certificate?
The website of the State Administration of Medical Products can be viewed at the medical device product inquiry portal!
Can I enter hospitals and pharmacies?
Most mechanical brands of drugs are plasters, which can be used in pharmacies and hospitals, but it is difficult to ask the top three, which can be used in general hospitals.
Strictly speaking, pharmacies or medical device companies with medical device business licenses can sell drugs with mechanical brand names, and then your varieties win the bid in the medical system bidding, and you can also sell them in hospitals.
What effect does the filing of medical representatives have on the representatives?
The biggest impact is that the random flow of medical representatives is greatly restricted, which directly determines that medical representatives used to be composed of part-time staff, and now they must set up full-time staff.